AUA Annual Meeting 2014

ORLANDO – Two potential biomarkers for interstitial cystitis have been identified, according to Jayoung Kim, Ph.D.

The metabolites tyramine and 2-oxoglutarate appeared to discriminate 45 interstitial cystitis patients from 19 age- and gender-matched controls. The findings set the stage for prospective clinical trials of these potential biomarkers, Dr. Kim of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Urological Association.

Dr. Kim and her colleagues performed a nuclear magnetic resonance analysis of urine samples and identified 140 peaks that differed significantly between the two groups. Fifteen NMR peaks were identified as having the strongest signature for interstitial cystitis, she said.

Three of the peaks were annotated as the pain-related neuromodulator tyramine and two were 2-oxoglutarate. The findings suggest that levels of these two metabolites might be significantly upregulated in urine specimens from patients who have interstitial cystitis.

Patients with interstitial cystitis or painful bladder syndrome report variable symptoms, such as pelvic or perineal pain, discomfort, urinary frequency, and urinary urgency. A poor understanding of the mechanism of interstitial cystitis and the lack of convenient biomarkers have posed challenges to improving diagnosis and treatment. The findings elucidate clinically relevant disease indicators that could be important in the development of new treatments, Dr. Kim said.

This study was supported by grants from the National Institutes of Health, an ICA Pilot grant, the Fishbein Family IC Research Foundation/Interstitial Cystitis Association, the New York Academy of Medicine, and Children’s Hospital Boston Faculty Development.

ORLANDO – Two potential biomarkers for interstitial cystitis have been identified, according to Jayoung Kim, Ph.D.

The metabolites tyramine and 2-oxoglutarate appeared to discriminate 45 interstitial cystitis patients from 19 age- and gender-matched controls. The findings set the stage for prospective clinical trials of these potential biomarkers, Dr. Kim of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Urological Association.

Dr. Kim and her colleagues performed a nuclear magnetic resonance analysis of urine samples and identified 140 peaks that differed significantly between the two groups. Fifteen NMR peaks were identified as having the strongest signature for interstitial cystitis, she said.

Three of the peaks were annotated as the pain-related neuromodulator tyramine and two were 2-oxoglutarate. The findings suggest that levels of these two metabolites might be significantly upregulated in urine specimens from patients who have interstitial cystitis.

Patients with interstitial cystitis or painful bladder syndrome report variable symptoms, such as pelvic or perineal pain, discomfort, urinary frequency, and urinary urgency. A poor understanding of the mechanism of interstitial cystitis and the lack of convenient biomarkers have posed challenges to improving diagnosis and treatment. The findings elucidate clinically relevant disease indicators that could be important in the development of new treatments, Dr. Kim said.

This study was supported by grants from the National Institutes of Health, an ICA Pilot grant, the Fishbein Family IC Research Foundation/Interstitial Cystitis Association, the New York Academy of Medicine, and Children’s Hospital Boston Faculty Development.

ORLANDO – Two potential biomarkers for interstitial cystitis have been identified, according to Jayoung Kim, Ph.D.

The metabolites tyramine and 2-oxoglutarate appeared to discriminate 45 interstitial cystitis patients from 19 age- and gender-matched controls. The findings set the stage for prospective clinical trials of these potential biomarkers, Dr. Kim of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Urological Association.

Dr. Kim and her colleagues performed a nuclear magnetic resonance analysis of urine samples and identified 140 peaks that differed significantly between the two groups. Fifteen NMR peaks were identified as having the strongest signature for interstitial cystitis, she said.

Three of the peaks were annotated as the pain-related neuromodulator tyramine and two were 2-oxoglutarate. The findings suggest that levels of these two metabolites might be significantly upregulated in urine specimens from patients who have interstitial cystitis.

Patients with interstitial cystitis or painful bladder syndrome report variable symptoms, such as pelvic or perineal pain, discomfort, urinary frequency, and urinary urgency. A poor understanding of the mechanism of interstitial cystitis and the lack of convenient biomarkers have posed challenges to improving diagnosis and treatment. The findings elucidate clinically relevant disease indicators that could be important in the development of new treatments, Dr. Kim said.

This study was supported by grants from the National Institutes of Health, an ICA Pilot grant, the Fishbein Family IC Research Foundation/Interstitial Cystitis Association, the New York Academy of Medicine, and Children’s Hospital Boston Faculty Development.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Antibiotic prophylaxis was shown in the recently published RIVUR trial to halve the risk of recurrent febrile urinary tract infection in infants and young children with vesicoureteral reflux. Conversely, a meta-analysis of six controlled trials concluded there is little to no benefit of antibiotic prophylaxis in this population.

The conflicting data highlight the ongoing debate regarding the best approach for preventing and managing febrile urinary tract infections (UTIs) in children with vesicoureteral reflux (VUR).

The RIVUR (Randomized Intervention for Children with Vesicoureteral Reflux) trial findings, which were published in May in the New England Journal of Medicine, showed that among children with VUR who were aged 2-71 months, 2 years of treatment with trimethoprim-sulfamethoxazole halved the risk of febrile or symptomatic UTI recurrence (N. Eng. J. Med. 2014;370:2367-76). The difference between those who received prophylaxis and those who did not emerged early and increased over the 2-year study period, Dr. Saul Greenfield said during an update on the trial results at the annual meeting of the American Urological Association.

"The magnitude of treatment effect warrants serious consideration of prophylaxis in these children. We also feel that these results warrant reconsideration of the recent guideline recommendations by the American Academy of Pediatrics in 2011 ... advising against evaluation of children with a VCUG [voiding cystourethrogram] after their first UTI," said Dr. Greenfield, director of pediatric urology at Women and Children’s Hospital of Buffalo, N.Y. and one of the RIVUR investigators.

That AAP recommendation was based on a number of studies that showed no benefit from antibiotic prophylaxis in children with VUR, which suggests there is little value in diagnosing VUR (Pediatrics 2011;28:595-610).

In fact, a meta-analysis of six controlled trials, which also was presented at the AUA meeting, suggested that the benefit of antibiotic prophylaxis for preventing febrile UTIs in children with VUR is small at best, and evidence to support its use is lacking.

Pooled data for 986 patients included in the trials showed that in 417 with dilating VUR, the risk of recurrent febrile UTI was 22.46% in those who received antibiotics, and 29.79% in controls. The relative risk of treatment failure with antibiotic prophylaxis was 0.75, and the absolute risk reduction was 7.33%, Dr. José Netto reported.

The number needed to treat to prevent one UTI was 13.64, according to Dr. Netto of State University of Feira de Santana in Brazil.

In 515 patients with nondilating VUR, the risk of febrile UTI was 5.31% in patients who received prophylactic antibiotics, and 6.09% in those who did not. The relative risk of treatment failure was 0.87, and the absolute risk reduction was 0.78%. The number needed to treat was 129, Dr. Netto said.

The studies included in the meta-analysis were published prior to August 2013. Only one was placebo-controlled. Patients included in the study included 663 girls (67.2%), and the median age of all patients was 21 months.

The studies all used co-trimoxazole in standard doses, and three of the six also used co-amoxiclav or nitrofurantoin as alternative treatments.

Antibiotic prophylaxis is often used in children with VUR, but several recent studies have failed to demonstrate the usefulness of this approach with respect to reducing the risk of febrile UTI, Dr. Netto said, noting that the studies included heterogeneous populations with distinct grades of VUR and varying rates of recurrent UTI.

Based on the current findings, it remains uncertain whether antibiotic prophylaxis reduces the risk of febrile UTI in children with VUR, although it is possible – given the differences seen between those with dilating VUR and those with nondilating VUR – that specific subgroups of children with dilating VUR may benefit from prophylaxis, he concluded.

The conflicting findings between this meta-analysis, and the RIVUR trial underscore the importance of ongoing evaluation of antibiotic prophylaxis.

"The best ways to prevent and treat febrile urinary tract infections in children with VUR are still very much up for discussion," Dr. Anthony Atala, W.H. Boyce Professor and chair of the urology department at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in an AUA press statement.

"Examining and reexamining the AAP guidelines and practices that guide our work are critical to better understand the condition and improve the lives of those children who are living with the condition each day," said Dr. Atala, who is also director of the Wake Forest Institute for Regenerative Medicine.

Dr. Atala reported serving in a leadership position at Plureon Corp. Dr. Greenfield and Dr. Netto reported having no disclosures.

ORLANDO – Antibiotic prophylaxis was shown in the recently published RIVUR trial to halve the risk of recurrent febrile urinary tract infection in infants and young children with vesicoureteral reflux. Conversely, a meta-analysis of six controlled trials concluded there is little to no benefit of antibiotic prophylaxis in this population.

The conflicting data highlight the ongoing debate regarding the best approach for preventing and managing febrile urinary tract infections (UTIs) in children with vesicoureteral reflux (VUR).

The RIVUR (Randomized Intervention for Children with Vesicoureteral Reflux) trial findings, which were published in May in the New England Journal of Medicine, showed that among children with VUR who were aged 2-71 months, 2 years of treatment with trimethoprim-sulfamethoxazole halved the risk of febrile or symptomatic UTI recurrence (N. Eng. J. Med. 2014;370:2367-76). The difference between those who received prophylaxis and those who did not emerged early and increased over the 2-year study period, Dr. Saul Greenfield said during an update on the trial results at the annual meeting of the American Urological Association.

"The magnitude of treatment effect warrants serious consideration of prophylaxis in these children. We also feel that these results warrant reconsideration of the recent guideline recommendations by the American Academy of Pediatrics in 2011 ... advising against evaluation of children with a VCUG [voiding cystourethrogram] after their first UTI," said Dr. Greenfield, director of pediatric urology at Women and Children’s Hospital of Buffalo, N.Y. and one of the RIVUR investigators.

That AAP recommendation was based on a number of studies that showed no benefit from antibiotic prophylaxis in children with VUR, which suggests there is little value in diagnosing VUR (Pediatrics 2011;28:595-610).

In fact, a meta-analysis of six controlled trials, which also was presented at the AUA meeting, suggested that the benefit of antibiotic prophylaxis for preventing febrile UTIs in children with VUR is small at best, and evidence to support its use is lacking.

Pooled data for 986 patients included in the trials showed that in 417 with dilating VUR, the risk of recurrent febrile UTI was 22.46% in those who received antibiotics, and 29.79% in controls. The relative risk of treatment failure with antibiotic prophylaxis was 0.75, and the absolute risk reduction was 7.33%, Dr. José Netto reported.

The number needed to treat to prevent one UTI was 13.64, according to Dr. Netto of State University of Feira de Santana in Brazil.

In 515 patients with nondilating VUR, the risk of febrile UTI was 5.31% in patients who received prophylactic antibiotics, and 6.09% in those who did not. The relative risk of treatment failure was 0.87, and the absolute risk reduction was 0.78%. The number needed to treat was 129, Dr. Netto said.

The studies included in the meta-analysis were published prior to August 2013. Only one was placebo-controlled. Patients included in the study included 663 girls (67.2%), and the median age of all patients was 21 months.

The studies all used co-trimoxazole in standard doses, and three of the six also used co-amoxiclav or nitrofurantoin as alternative treatments.

Antibiotic prophylaxis is often used in children with VUR, but several recent studies have failed to demonstrate the usefulness of this approach with respect to reducing the risk of febrile UTI, Dr. Netto said, noting that the studies included heterogeneous populations with distinct grades of VUR and varying rates of recurrent UTI.

Based on the current findings, it remains uncertain whether antibiotic prophylaxis reduces the risk of febrile UTI in children with VUR, although it is possible – given the differences seen between those with dilating VUR and those with nondilating VUR – that specific subgroups of children with dilating VUR may benefit from prophylaxis, he concluded.

The conflicting findings between this meta-analysis, and the RIVUR trial underscore the importance of ongoing evaluation of antibiotic prophylaxis.

"The best ways to prevent and treat febrile urinary tract infections in children with VUR are still very much up for discussion," Dr. Anthony Atala, W.H. Boyce Professor and chair of the urology department at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in an AUA press statement.

"Examining and reexamining the AAP guidelines and practices that guide our work are critical to better understand the condition and improve the lives of those children who are living with the condition each day," said Dr. Atala, who is also director of the Wake Forest Institute for Regenerative Medicine.

Dr. Atala reported serving in a leadership position at Plureon Corp. Dr. Greenfield and Dr. Netto reported having no disclosures.

ORLANDO – Antibiotic prophylaxis was shown in the recently published RIVUR trial to halve the risk of recurrent febrile urinary tract infection in infants and young children with vesicoureteral reflux. Conversely, a meta-analysis of six controlled trials concluded there is little to no benefit of antibiotic prophylaxis in this population.

The conflicting data highlight the ongoing debate regarding the best approach for preventing and managing febrile urinary tract infections (UTIs) in children with vesicoureteral reflux (VUR).

The RIVUR (Randomized Intervention for Children with Vesicoureteral Reflux) trial findings, which were published in May in the New England Journal of Medicine, showed that among children with VUR who were aged 2-71 months, 2 years of treatment with trimethoprim-sulfamethoxazole halved the risk of febrile or symptomatic UTI recurrence (N. Eng. J. Med. 2014;370:2367-76). The difference between those who received prophylaxis and those who did not emerged early and increased over the 2-year study period, Dr. Saul Greenfield said during an update on the trial results at the annual meeting of the American Urological Association.

"The magnitude of treatment effect warrants serious consideration of prophylaxis in these children. We also feel that these results warrant reconsideration of the recent guideline recommendations by the American Academy of Pediatrics in 2011 ... advising against evaluation of children with a VCUG [voiding cystourethrogram] after their first UTI," said Dr. Greenfield, director of pediatric urology at Women and Children’s Hospital of Buffalo, N.Y. and one of the RIVUR investigators.

That AAP recommendation was based on a number of studies that showed no benefit from antibiotic prophylaxis in children with VUR, which suggests there is little value in diagnosing VUR (Pediatrics 2011;28:595-610).

In fact, a meta-analysis of six controlled trials, which also was presented at the AUA meeting, suggested that the benefit of antibiotic prophylaxis for preventing febrile UTIs in children with VUR is small at best, and evidence to support its use is lacking.

Pooled data for 986 patients included in the trials showed that in 417 with dilating VUR, the risk of recurrent febrile UTI was 22.46% in those who received antibiotics, and 29.79% in controls. The relative risk of treatment failure with antibiotic prophylaxis was 0.75, and the absolute risk reduction was 7.33%, Dr. José Netto reported.

The number needed to treat to prevent one UTI was 13.64, according to Dr. Netto of State University of Feira de Santana in Brazil.

In 515 patients with nondilating VUR, the risk of febrile UTI was 5.31% in patients who received prophylactic antibiotics, and 6.09% in those who did not. The relative risk of treatment failure was 0.87, and the absolute risk reduction was 0.78%. The number needed to treat was 129, Dr. Netto said.

The studies included in the meta-analysis were published prior to August 2013. Only one was placebo-controlled. Patients included in the study included 663 girls (67.2%), and the median age of all patients was 21 months.

The studies all used co-trimoxazole in standard doses, and three of the six also used co-amoxiclav or nitrofurantoin as alternative treatments.

Antibiotic prophylaxis is often used in children with VUR, but several recent studies have failed to demonstrate the usefulness of this approach with respect to reducing the risk of febrile UTI, Dr. Netto said, noting that the studies included heterogeneous populations with distinct grades of VUR and varying rates of recurrent UTI.

Based on the current findings, it remains uncertain whether antibiotic prophylaxis reduces the risk of febrile UTI in children with VUR, although it is possible – given the differences seen between those with dilating VUR and those with nondilating VUR – that specific subgroups of children with dilating VUR may benefit from prophylaxis, he concluded.

The conflicting findings between this meta-analysis, and the RIVUR trial underscore the importance of ongoing evaluation of antibiotic prophylaxis.

"The best ways to prevent and treat febrile urinary tract infections in children with VUR are still very much up for discussion," Dr. Anthony Atala, W.H. Boyce Professor and chair of the urology department at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in an AUA press statement.

"Examining and reexamining the AAP guidelines and practices that guide our work are critical to better understand the condition and improve the lives of those children who are living with the condition each day," said Dr. Atala, who is also director of the Wake Forest Institute for Regenerative Medicine.

Dr. Atala reported serving in a leadership position at Plureon Corp. Dr. Greenfield and Dr. Netto reported having no disclosures.

ORLANDO – Lignan-type phytoestrogens, but not isoflavone-type phytoestrogens, were associated with a decreased risk for incontinence symptoms in women, based on findings from a large prospective population-based cohort study.

Lignan-type phytoestrogens are found in a wide variety of plant-based foods including flaxseeds, sesame seeds, legumes, whole grains, fruits, and vegetables. Isoflavone-type phytoestrogens are found primarily in soybeans and soy-based products.

The study is the first to demonstrate an association between urinary phytoestrogen levels and urinary symptoms, according to the study’s author, Dr. Evgeniy I. Kreydin of Massachusetts General Hospital, Boston. Prospective studies are warranted to investigate the mechanism for this relationship, he added.

Increasing concentrations of the lignan phytoestrogens enterolactone and enterodiol were associated with significantly decreased likelihood of urge incontinence, bother from incontinence, and effect of urinary incontinence on daily living in 4,104 women who participated in the NHANES (National Health and Nutrition Examination Survey) between 2000 and 2010. Increasing concentrations of enterolactone were also associated with significantly decreased likelihood of "other incontinence," Dr. Kreydin reported during an "outstanding posters" session at the annual meeting of the American Urological Association.

Odds ratios for urinary symptoms per unit change in urinary enterodiol and enterolactone concentrations, respectively, were 0.43, 0.49, 0.32, and 0.14, and 0.47, 0.32, 0.30. The odds ratio per unit change was 0.24 for urge incontinence, other incontinence, incontinence bother, and incontinence effect on daily activities, Dr. Kreydin said.

Alternatively, none of the isoflavone-type phytoestrogens was associated with decreased urinary symptoms in this study. In fact, one isoflavone-type phytoestrogen – genistein – was associated with an increased likelihood of incontinence bother (odds ratio, 2.45).

Study subjects completed a urinary function and quality of life questionnaire and underwent measurement of urinary phytoestrogen levels. Urinary symptoms were assessed after adjusting for age, race, smoking status, body mass index, diabetes, parity, and menopausal status – factors known to affect lower urinary tract symptoms in women.

Dr. Kreydin reported having no relevant financial disclosures.

ORLANDO – Lignan-type phytoestrogens, but not isoflavone-type phytoestrogens, were associated with a decreased risk for incontinence symptoms in women, based on findings from a large prospective population-based cohort study.

Lignan-type phytoestrogens are found in a wide variety of plant-based foods including flaxseeds, sesame seeds, legumes, whole grains, fruits, and vegetables. Isoflavone-type phytoestrogens are found primarily in soybeans and soy-based products.

The study is the first to demonstrate an association between urinary phytoestrogen levels and urinary symptoms, according to the study’s author, Dr. Evgeniy I. Kreydin of Massachusetts General Hospital, Boston. Prospective studies are warranted to investigate the mechanism for this relationship, he added.

Increasing concentrations of the lignan phytoestrogens enterolactone and enterodiol were associated with significantly decreased likelihood of urge incontinence, bother from incontinence, and effect of urinary incontinence on daily living in 4,104 women who participated in the NHANES (National Health and Nutrition Examination Survey) between 2000 and 2010. Increasing concentrations of enterolactone were also associated with significantly decreased likelihood of "other incontinence," Dr. Kreydin reported during an "outstanding posters" session at the annual meeting of the American Urological Association.

Odds ratios for urinary symptoms per unit change in urinary enterodiol and enterolactone concentrations, respectively, were 0.43, 0.49, 0.32, and 0.14, and 0.47, 0.32, 0.30. The odds ratio per unit change was 0.24 for urge incontinence, other incontinence, incontinence bother, and incontinence effect on daily activities, Dr. Kreydin said.

Alternatively, none of the isoflavone-type phytoestrogens was associated with decreased urinary symptoms in this study. In fact, one isoflavone-type phytoestrogen – genistein – was associated with an increased likelihood of incontinence bother (odds ratio, 2.45).

Study subjects completed a urinary function and quality of life questionnaire and underwent measurement of urinary phytoestrogen levels. Urinary symptoms were assessed after adjusting for age, race, smoking status, body mass index, diabetes, parity, and menopausal status – factors known to affect lower urinary tract symptoms in women.

Dr. Kreydin reported having no relevant financial disclosures.

ORLANDO – Lignan-type phytoestrogens, but not isoflavone-type phytoestrogens, were associated with a decreased risk for incontinence symptoms in women, based on findings from a large prospective population-based cohort study.

Lignan-type phytoestrogens are found in a wide variety of plant-based foods including flaxseeds, sesame seeds, legumes, whole grains, fruits, and vegetables. Isoflavone-type phytoestrogens are found primarily in soybeans and soy-based products.

The study is the first to demonstrate an association between urinary phytoestrogen levels and urinary symptoms, according to the study’s author, Dr. Evgeniy I. Kreydin of Massachusetts General Hospital, Boston. Prospective studies are warranted to investigate the mechanism for this relationship, he added.

Increasing concentrations of the lignan phytoestrogens enterolactone and enterodiol were associated with significantly decreased likelihood of urge incontinence, bother from incontinence, and effect of urinary incontinence on daily living in 4,104 women who participated in the NHANES (National Health and Nutrition Examination Survey) between 2000 and 2010. Increasing concentrations of enterolactone were also associated with significantly decreased likelihood of "other incontinence," Dr. Kreydin reported during an "outstanding posters" session at the annual meeting of the American Urological Association.

Odds ratios for urinary symptoms per unit change in urinary enterodiol and enterolactone concentrations, respectively, were 0.43, 0.49, 0.32, and 0.14, and 0.47, 0.32, 0.30. The odds ratio per unit change was 0.24 for urge incontinence, other incontinence, incontinence bother, and incontinence effect on daily activities, Dr. Kreydin said.

Alternatively, none of the isoflavone-type phytoestrogens was associated with decreased urinary symptoms in this study. In fact, one isoflavone-type phytoestrogen – genistein – was associated with an increased likelihood of incontinence bother (odds ratio, 2.45).

Study subjects completed a urinary function and quality of life questionnaire and underwent measurement of urinary phytoestrogen levels. Urinary symptoms were assessed after adjusting for age, race, smoking status, body mass index, diabetes, parity, and menopausal status – factors known to affect lower urinary tract symptoms in women.

Dr. Kreydin reported having no relevant financial disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Treatment with enzalutamide significantly improved survival and radiographic progression-free survival in men with chemotherapy-naive metastatic prostate cancer – including those with visceral disease – according to a subgroup analysis of the randomized, double-blind PREVAIL study.

Of 1,717 patients in the study, 204 had visceral disease at screening, including 130 with lung disease and 74 with lung disease and/or liver disease. Those without visceral disease had lower baseline median prostate-specific antigen levels (46.8 vs. 72.5 ng/mL), better performance status (68.9 vs. 61.8%), and less lymph node disease (49.8% vs. 57.8%), than those with visceral disease, but the two groups had similar rates of bone disease (83.7% and 80.4%), Dr. Christopher Evans reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

"That patients with visceral disease were included in the study is very important, as other studies have excluded patients with visceral disease," Dr. Evans said.

Overall survival in the PREVAIL study, as reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February and online June 1 in the New England Journal of Medicine (N. Engl. J. Med. 2014 June 1 [doi:10.1056/NEJMoa1405095]), was significantly better in patients who received enzalutamide, compared with those who received placebo (32.4 vs. 30.2 months; hazard ratio, 0.71). In the current subgroup analysis comparing those with and without visceral disease, overall survival in those with visceral disease was 27.8 months and 22.8 months in the treatment and placebo groups, respectively (hazard ratio, 0.82). In those without visceral disease, the median time to death was not yet reached, said Dr. Evans of the department of urology, University of California Davis Health System, Sacramento.

Median radiographic progression-free survival duration in those with visceral disease was not yet reached in the treatment group and was 3.6 months in the placebo group, and in those without visceral disease it was 14.1 vs. 4.0 months with treatment vs. placebo (hazard ratio, 0.18), he said.

Additionally, patients without visceral disease, who may be more likely to be seen in the urologist’s office, were much less likely to use a subsequent life-extending therapy (typically docetaxel) if they received enzalutamide treatment rather than placebo (40% vs. 70%), Dr. Evans noted.

In a post hoc analysis, the secondary endpoint of time to cytotoxic chemotherapy was 28 vs. 10.8 months overall in the treatment vs. placebo group (HR, 0.35), 22.6 vs. 6.6 months for treatment vs. placebo in those with visceral disease (HR, 0.30), and 28.4 vs. 11.6 months for treatment vs. placebo in those without visceral disease (HR, 0.36).

"These curves are similar again in the visceral and nonvisceral subgroups. However, if we look at the placebo subgroup in the intention-to-treat population, we can see that median time to initiation of chemotherapy is 12 months. This is similar in the nonvisceral sub group, but is 6.5 months in the visceral subgroup – again showing that these patients have worse disease burden," he said.

In the intention-to-treat population, there was an 18-month improvement overall in the time to initiation of chemotherapy, giving urologists an opportunity to get involved in the treatment of these patients, he added.

The PREVAIL study examined the impact of oral enzalutamide (160 mg/day, compared with placebo, in asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic prostate cancer. The study, which was conducted at 207 centers in 22 countries between September 2010 and September 2012, was stopped at an interim analysis based on the significant survival benefits seen in the enzalutamide-treated patients. The current subgroup analysis demonstrates that although patients with visceral disease progressed more rapidly regardless of treatment allocation, the benefit of enzalutamide was consistent among patients with or without visceral disease.

Dr. Evans disclosed relationships with Amgen, Astellas, Medivation, Janssen, and Oncogenex, and investment interests in Medivation and Oncogenex.

ORLANDO – Treatment with enzalutamide significantly improved survival and radiographic progression-free survival in men with chemotherapy-naive metastatic prostate cancer – including those with visceral disease – according to a subgroup analysis of the randomized, double-blind PREVAIL study.

Of 1,717 patients in the study, 204 had visceral disease at screening, including 130 with lung disease and 74 with lung disease and/or liver disease. Those without visceral disease had lower baseline median prostate-specific antigen levels (46.8 vs. 72.5 ng/mL), better performance status (68.9 vs. 61.8%), and less lymph node disease (49.8% vs. 57.8%), than those with visceral disease, but the two groups had similar rates of bone disease (83.7% and 80.4%), Dr. Christopher Evans reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

"That patients with visceral disease were included in the study is very important, as other studies have excluded patients with visceral disease," Dr. Evans said.

Overall survival in the PREVAIL study, as reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February and online June 1 in the New England Journal of Medicine (N. Engl. J. Med. 2014 June 1 [doi:10.1056/NEJMoa1405095]), was significantly better in patients who received enzalutamide, compared with those who received placebo (32.4 vs. 30.2 months; hazard ratio, 0.71). In the current subgroup analysis comparing those with and without visceral disease, overall survival in those with visceral disease was 27.8 months and 22.8 months in the treatment and placebo groups, respectively (hazard ratio, 0.82). In those without visceral disease, the median time to death was not yet reached, said Dr. Evans of the department of urology, University of California Davis Health System, Sacramento.

Median radiographic progression-free survival duration in those with visceral disease was not yet reached in the treatment group and was 3.6 months in the placebo group, and in those without visceral disease it was 14.1 vs. 4.0 months with treatment vs. placebo (hazard ratio, 0.18), he said.

Additionally, patients without visceral disease, who may be more likely to be seen in the urologist’s office, were much less likely to use a subsequent life-extending therapy (typically docetaxel) if they received enzalutamide treatment rather than placebo (40% vs. 70%), Dr. Evans noted.

In a post hoc analysis, the secondary endpoint of time to cytotoxic chemotherapy was 28 vs. 10.8 months overall in the treatment vs. placebo group (HR, 0.35), 22.6 vs. 6.6 months for treatment vs. placebo in those with visceral disease (HR, 0.30), and 28.4 vs. 11.6 months for treatment vs. placebo in those without visceral disease (HR, 0.36).

"These curves are similar again in the visceral and nonvisceral subgroups. However, if we look at the placebo subgroup in the intention-to-treat population, we can see that median time to initiation of chemotherapy is 12 months. This is similar in the nonvisceral sub group, but is 6.5 months in the visceral subgroup – again showing that these patients have worse disease burden," he said.

In the intention-to-treat population, there was an 18-month improvement overall in the time to initiation of chemotherapy, giving urologists an opportunity to get involved in the treatment of these patients, he added.

The PREVAIL study examined the impact of oral enzalutamide (160 mg/day, compared with placebo, in asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic prostate cancer. The study, which was conducted at 207 centers in 22 countries between September 2010 and September 2012, was stopped at an interim analysis based on the significant survival benefits seen in the enzalutamide-treated patients. The current subgroup analysis demonstrates that although patients with visceral disease progressed more rapidly regardless of treatment allocation, the benefit of enzalutamide was consistent among patients with or without visceral disease.

Dr. Evans disclosed relationships with Amgen, Astellas, Medivation, Janssen, and Oncogenex, and investment interests in Medivation and Oncogenex.

ORLANDO – Treatment with enzalutamide significantly improved survival and radiographic progression-free survival in men with chemotherapy-naive metastatic prostate cancer – including those with visceral disease – according to a subgroup analysis of the randomized, double-blind PREVAIL study.

Of 1,717 patients in the study, 204 had visceral disease at screening, including 130 with lung disease and 74 with lung disease and/or liver disease. Those without visceral disease had lower baseline median prostate-specific antigen levels (46.8 vs. 72.5 ng/mL), better performance status (68.9 vs. 61.8%), and less lymph node disease (49.8% vs. 57.8%), than those with visceral disease, but the two groups had similar rates of bone disease (83.7% and 80.4%), Dr. Christopher Evans reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

"That patients with visceral disease were included in the study is very important, as other studies have excluded patients with visceral disease," Dr. Evans said.

Overall survival in the PREVAIL study, as reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February and online June 1 in the New England Journal of Medicine (N. Engl. J. Med. 2014 June 1 [doi:10.1056/NEJMoa1405095]), was significantly better in patients who received enzalutamide, compared with those who received placebo (32.4 vs. 30.2 months; hazard ratio, 0.71). In the current subgroup analysis comparing those with and without visceral disease, overall survival in those with visceral disease was 27.8 months and 22.8 months in the treatment and placebo groups, respectively (hazard ratio, 0.82). In those without visceral disease, the median time to death was not yet reached, said Dr. Evans of the department of urology, University of California Davis Health System, Sacramento.

Median radiographic progression-free survival duration in those with visceral disease was not yet reached in the treatment group and was 3.6 months in the placebo group, and in those without visceral disease it was 14.1 vs. 4.0 months with treatment vs. placebo (hazard ratio, 0.18), he said.

Additionally, patients without visceral disease, who may be more likely to be seen in the urologist’s office, were much less likely to use a subsequent life-extending therapy (typically docetaxel) if they received enzalutamide treatment rather than placebo (40% vs. 70%), Dr. Evans noted.

In a post hoc analysis, the secondary endpoint of time to cytotoxic chemotherapy was 28 vs. 10.8 months overall in the treatment vs. placebo group (HR, 0.35), 22.6 vs. 6.6 months for treatment vs. placebo in those with visceral disease (HR, 0.30), and 28.4 vs. 11.6 months for treatment vs. placebo in those without visceral disease (HR, 0.36).

"These curves are similar again in the visceral and nonvisceral subgroups. However, if we look at the placebo subgroup in the intention-to-treat population, we can see that median time to initiation of chemotherapy is 12 months. This is similar in the nonvisceral sub group, but is 6.5 months in the visceral subgroup – again showing that these patients have worse disease burden," he said.

In the intention-to-treat population, there was an 18-month improvement overall in the time to initiation of chemotherapy, giving urologists an opportunity to get involved in the treatment of these patients, he added.

The PREVAIL study examined the impact of oral enzalutamide (160 mg/day, compared with placebo, in asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic prostate cancer. The study, which was conducted at 207 centers in 22 countries between September 2010 and September 2012, was stopped at an interim analysis based on the significant survival benefits seen in the enzalutamide-treated patients. The current subgroup analysis demonstrates that although patients with visceral disease progressed more rapidly regardless of treatment allocation, the benefit of enzalutamide was consistent among patients with or without visceral disease.

Dr. Evans disclosed relationships with Amgen, Astellas, Medivation, Janssen, and Oncogenex, and investment interests in Medivation and Oncogenex.

ORLANDO – Screening men who are at high genetic risk for prostate cancer appears to provide a mortality benefit, according to an analysis of data from a randomized trial.

Of 73,200 men who participated in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial and who had complete records available, 297 died of prostate cancer, 8,432 were considered high risk, and 5,326 had a known family history of the disease. Screening in the PLCO trial did not provide an overall mortality benefit, but genetic high risk was found to be associated with prostate cancer mortality (African Americans and whites with a family history of prostate cancer, for example, had odds ratios for mortality of 2.6 and 1.5, respectively), Dr. Michael Liss, a urologic oncology fellow at the University of California, San Diego, reported during a "Best Abstracts" presentation at the annual meeting of the American Urological Association.

Furthermore, the incidence of prostate cancer was higher among those with a family history than among those with no family history (16.7% vs. 10.7%), and those with a family history who were screened, compared with those who received usual care, had lower prostate specific antigen levels at diagnosis (5.8 vs. 6.5), a faster time to diagnosis (4.6 vs. 5.8 years), and a more favorable Gleason score (312 vs. 236 had a score less than 6, 120 vs. 129 had a score of 7, and 37 vs. 41 had a score greater than 8, for example).

In the current analysis of only those with a family history of prostate cancer, 9 who were screened, compared with 18 who were not, died of prostate cancer (hazard ratio, 0.488).

"In a multivariable analysis, we noted a 50% reduction in prostate cancer death [in those who were screened]. However, due to limited events, we did not reach statistical significance, though a trend was noted," Dr. Liss said.

The median age of PLCO participants was 62 years, and median follow-up was 12.6 years.

The findings are important, because the U.S. Preventive Services Task Force recently recommended against PSA screening, and although the AUA currently recommends screening, particularly for men at high risk, there currently are no clinical data to support this practice, he said.

These findings support the AUA position and suggest that screening men at high genetic risk may yield benefits in terms of prostate cancer mortality.

"We noted that patients with a family history only accounted for 7% of patients in the trial, indicating that there’s some bias in family history, and that possibly in the future, genetic variants could apply additional knowledge to people who are family history negative for prostate cancer," he said.

Dr. Liss reported having no financial disclosures.

ORLANDO – Screening men who are at high genetic risk for prostate cancer appears to provide a mortality benefit, according to an analysis of data from a randomized trial.

Of 73,200 men who participated in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial and who had complete records available, 297 died of prostate cancer, 8,432 were considered high risk, and 5,326 had a known family history of the disease. Screening in the PLCO trial did not provide an overall mortality benefit, but genetic high risk was found to be associated with prostate cancer mortality (African Americans and whites with a family history of prostate cancer, for example, had odds ratios for mortality of 2.6 and 1.5, respectively), Dr. Michael Liss, a urologic oncology fellow at the University of California, San Diego, reported during a "Best Abstracts" presentation at the annual meeting of the American Urological Association.

Furthermore, the incidence of prostate cancer was higher among those with a family history than among those with no family history (16.7% vs. 10.7%), and those with a family history who were screened, compared with those who received usual care, had lower prostate specific antigen levels at diagnosis (5.8 vs. 6.5), a faster time to diagnosis (4.6 vs. 5.8 years), and a more favorable Gleason score (312 vs. 236 had a score less than 6, 120 vs. 129 had a score of 7, and 37 vs. 41 had a score greater than 8, for example).

In the current analysis of only those with a family history of prostate cancer, 9 who were screened, compared with 18 who were not, died of prostate cancer (hazard ratio, 0.488).

"In a multivariable analysis, we noted a 50% reduction in prostate cancer death [in those who were screened]. However, due to limited events, we did not reach statistical significance, though a trend was noted," Dr. Liss said.

The median age of PLCO participants was 62 years, and median follow-up was 12.6 years.

The findings are important, because the U.S. Preventive Services Task Force recently recommended against PSA screening, and although the AUA currently recommends screening, particularly for men at high risk, there currently are no clinical data to support this practice, he said.

These findings support the AUA position and suggest that screening men at high genetic risk may yield benefits in terms of prostate cancer mortality.

"We noted that patients with a family history only accounted for 7% of patients in the trial, indicating that there’s some bias in family history, and that possibly in the future, genetic variants could apply additional knowledge to people who are family history negative for prostate cancer," he said.

Dr. Liss reported having no financial disclosures.

ORLANDO – Screening men who are at high genetic risk for prostate cancer appears to provide a mortality benefit, according to an analysis of data from a randomized trial.

Of 73,200 men who participated in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial and who had complete records available, 297 died of prostate cancer, 8,432 were considered high risk, and 5,326 had a known family history of the disease. Screening in the PLCO trial did not provide an overall mortality benefit, but genetic high risk was found to be associated with prostate cancer mortality (African Americans and whites with a family history of prostate cancer, for example, had odds ratios for mortality of 2.6 and 1.5, respectively), Dr. Michael Liss, a urologic oncology fellow at the University of California, San Diego, reported during a "Best Abstracts" presentation at the annual meeting of the American Urological Association.

Furthermore, the incidence of prostate cancer was higher among those with a family history than among those with no family history (16.7% vs. 10.7%), and those with a family history who were screened, compared with those who received usual care, had lower prostate specific antigen levels at diagnosis (5.8 vs. 6.5), a faster time to diagnosis (4.6 vs. 5.8 years), and a more favorable Gleason score (312 vs. 236 had a score less than 6, 120 vs. 129 had a score of 7, and 37 vs. 41 had a score greater than 8, for example).

In the current analysis of only those with a family history of prostate cancer, 9 who were screened, compared with 18 who were not, died of prostate cancer (hazard ratio, 0.488).

"In a multivariable analysis, we noted a 50% reduction in prostate cancer death [in those who were screened]. However, due to limited events, we did not reach statistical significance, though a trend was noted," Dr. Liss said.

The median age of PLCO participants was 62 years, and median follow-up was 12.6 years.

The findings are important, because the U.S. Preventive Services Task Force recently recommended against PSA screening, and although the AUA currently recommends screening, particularly for men at high risk, there currently are no clinical data to support this practice, he said.

These findings support the AUA position and suggest that screening men at high genetic risk may yield benefits in terms of prostate cancer mortality.

"We noted that patients with a family history only accounted for 7% of patients in the trial, indicating that there’s some bias in family history, and that possibly in the future, genetic variants could apply additional knowledge to people who are family history negative for prostate cancer," he said.

Dr. Liss reported having no financial disclosures.

ORLANDO – Specially trained dogs accurately detected specific prostate cancer volatile organic compounds in urine samples from patients with varying stages of disease and risk levels in a controlled study.

One dog was able to distinguish 320 urine samples taken from prostate cancer patients from 357 control samples with 100% sensitivity, 97.8% specificity, and 98.9% accuracy. A second dog performed with 98.6% sensitivity, 95.9% specificity, and 97.3% accuracy, Dr. Gianluigi Taverna of Humanitas Research Hospital, Milan, reported at the annual meeting of the American Urological Association.

The combined performance of the dogs – German shepherds trained by a dedicated research team using hundreds of urine samples over several months – resulted in 98.1% accuracy, 99.2% sensitivity, and 97.1% specificity.

Samples used in the study were from prostate cancer patients with cancer raging from very low risk disease to metastatic disease, and controls were a heterogeneous cohort of healthy subjects or patients affected by nonneoplastic diseases or nonprostatic tumors.

An evaluation of the wrongly detected cases showed that there were no differences in the specimens with respect to epidemiological, clinical, or histopathological characteristics, Dr. Taverna said.

Interest in the analysis of volatile organic compounds (VOCs) in urine is increasing, as this is considered a promising approach to cancer detection, and based on the findings of the current study it appears that a rigorously trained canine olfactory system can recognize prostate cancer VOCs, and thus represents a "real clinical opportunity" to reduce unnecessary biopsies and identify patients at high risk for prostate cancer, he concluded.

Dr. Brian Stork of West Shore Urology, Muskegon, Michigan, who moderated a press briefing where the findings were presented, said that the data highlight the potential value of VOCs in urine as a means for cancer detection.

"The possibility of using dogs in identifying cancer is something most would never have considered possible a decade or two ago. It’s an interesting concept that ‘man’s best friend’ could help save your life," he said in press statement.

It has been long known, however, that dogs have a highly sensitive olfactory system, with roughly 200 million olfactory cells in their noses, compared with about 5 million for humans, and interest in tapping their potential in medicine has been on the rise. Research has shown that dogs are capable of detecting epileptic seizure onset, and breast and lung malignancies through the detection of VOCs. In 2010, a small study of 33 patients suggested that dogs could detect prostate cancer VOCs in urine; the current study, in a much larger cohort, confirms those findings.

Dr. Taverna reported having no disclosures.

ORLANDO – Specially trained dogs accurately detected specific prostate cancer volatile organic compounds in urine samples from patients with varying stages of disease and risk levels in a controlled study.

One dog was able to distinguish 320 urine samples taken from prostate cancer patients from 357 control samples with 100% sensitivity, 97.8% specificity, and 98.9% accuracy. A second dog performed with 98.6% sensitivity, 95.9% specificity, and 97.3% accuracy, Dr. Gianluigi Taverna of Humanitas Research Hospital, Milan, reported at the annual meeting of the American Urological Association.

The combined performance of the dogs – German shepherds trained by a dedicated research team using hundreds of urine samples over several months – resulted in 98.1% accuracy, 99.2% sensitivity, and 97.1% specificity.

Samples used in the study were from prostate cancer patients with cancer raging from very low risk disease to metastatic disease, and controls were a heterogeneous cohort of healthy subjects or patients affected by nonneoplastic diseases or nonprostatic tumors.

An evaluation of the wrongly detected cases showed that there were no differences in the specimens with respect to epidemiological, clinical, or histopathological characteristics, Dr. Taverna said.

Interest in the analysis of volatile organic compounds (VOCs) in urine is increasing, as this is considered a promising approach to cancer detection, and based on the findings of the current study it appears that a rigorously trained canine olfactory system can recognize prostate cancer VOCs, and thus represents a "real clinical opportunity" to reduce unnecessary biopsies and identify patients at high risk for prostate cancer, he concluded.

Dr. Brian Stork of West Shore Urology, Muskegon, Michigan, who moderated a press briefing where the findings were presented, said that the data highlight the potential value of VOCs in urine as a means for cancer detection.

"The possibility of using dogs in identifying cancer is something most would never have considered possible a decade or two ago. It’s an interesting concept that ‘man’s best friend’ could help save your life," he said in press statement.

It has been long known, however, that dogs have a highly sensitive olfactory system, with roughly 200 million olfactory cells in their noses, compared with about 5 million for humans, and interest in tapping their potential in medicine has been on the rise. Research has shown that dogs are capable of detecting epileptic seizure onset, and breast and lung malignancies through the detection of VOCs. In 2010, a small study of 33 patients suggested that dogs could detect prostate cancer VOCs in urine; the current study, in a much larger cohort, confirms those findings.

Dr. Taverna reported having no disclosures.

ORLANDO – Specially trained dogs accurately detected specific prostate cancer volatile organic compounds in urine samples from patients with varying stages of disease and risk levels in a controlled study.

One dog was able to distinguish 320 urine samples taken from prostate cancer patients from 357 control samples with 100% sensitivity, 97.8% specificity, and 98.9% accuracy. A second dog performed with 98.6% sensitivity, 95.9% specificity, and 97.3% accuracy, Dr. Gianluigi Taverna of Humanitas Research Hospital, Milan, reported at the annual meeting of the American Urological Association.

The combined performance of the dogs – German shepherds trained by a dedicated research team using hundreds of urine samples over several months – resulted in 98.1% accuracy, 99.2% sensitivity, and 97.1% specificity.

Samples used in the study were from prostate cancer patients with cancer raging from very low risk disease to metastatic disease, and controls were a heterogeneous cohort of healthy subjects or patients affected by nonneoplastic diseases or nonprostatic tumors.

An evaluation of the wrongly detected cases showed that there were no differences in the specimens with respect to epidemiological, clinical, or histopathological characteristics, Dr. Taverna said.

Interest in the analysis of volatile organic compounds (VOCs) in urine is increasing, as this is considered a promising approach to cancer detection, and based on the findings of the current study it appears that a rigorously trained canine olfactory system can recognize prostate cancer VOCs, and thus represents a "real clinical opportunity" to reduce unnecessary biopsies and identify patients at high risk for prostate cancer, he concluded.

Dr. Brian Stork of West Shore Urology, Muskegon, Michigan, who moderated a press briefing where the findings were presented, said that the data highlight the potential value of VOCs in urine as a means for cancer detection.

"The possibility of using dogs in identifying cancer is something most would never have considered possible a decade or two ago. It’s an interesting concept that ‘man’s best friend’ could help save your life," he said in press statement.

It has been long known, however, that dogs have a highly sensitive olfactory system, with roughly 200 million olfactory cells in their noses, compared with about 5 million for humans, and interest in tapping their potential in medicine has been on the rise. Research has shown that dogs are capable of detecting epileptic seizure onset, and breast and lung malignancies through the detection of VOCs. In 2010, a small study of 33 patients suggested that dogs could detect prostate cancer VOCs in urine; the current study, in a much larger cohort, confirms those findings.

Dr. Taverna reported having no disclosures.

ORLANDO – A four kallikrein assay panel of human kallikrein and total, free, and intact prostate-specific antigen combined in an algorithm with age, digital rectal examination, and prior biopsy status provides a very high degree of discrimination for prostate cancer, compared with a PSA-based clinical algorithm, according to Dr. Daniel Lin.

The test (4Kscore test) was adapted from European studies which demonstrated that it is an accurate predictor of biopsy results, particularly for Gleason score 7 or greater disease, Dr. Lin of the University of Washington Medical Center, Seattle, reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

In a prospective, blinded study, calibration of the 4Kscore algorithm in the first 300 patients enrolled from October 2013 to January 2014 was nearly perfect, compared with the European version, showing that the score works on an individual level, he said.

At one illustrative cut point, the score would have reduced the number of biopsies by 41%, with a negative-predictive value of 97%.

The test is of value at the population level, as well.

For high-grade disease, the 4Kscore test had a "very high and very robust" area under the curve of 0.82.

"The best comparator might be the [Prostate Cancer Prevention Trial] risk calculator, which takes into account age, PSA, Gleason grade, race, prior biopsy status, and the rectal examination," Dr. Lin said, explaining that findings with the two scores were "clearly nonoverlapping."

Even in the high-grade disease with a PSA of 2-10 in the "diagnostic gray zone," the 4Kscore test showed superiority for discrimination of high-grade disease.

A decision analysis demonstrated that clinical decision-making would be improved by the use of the 4Kscore test, he said.

Study subjects were 1,300 men scheduled for biopsy at any of 26 U.S. urology centers. Following phlebotomy, participants underwent at least a 10-core transrectal ultrasound-guided biopsy. The first 300 patients represented a calibration cohort, and the remaining 1,000 are part of a validation cohort.

The findings are of note, because controversy exists with respect to the use of PSA screening.

"We all know there are several challenges surrounding the early detection of prostate cancer, and particularly screening with PSA," Dr. Lin said, noting that positive screens lead to unnecessary biopsies.

In fact, about 60% of initial biopsies are negative, and about half of those that are positive are low-grade, potentially indolent disease, he said.

This, along with the fact that biopsies can be associated with complications and patient anxiety, has led to a negative perception of PSA screening among some medical organizations such as the U.S. Preventive Services Task Force, which has recommended against PSA screening of healthy men, despite evidence that PSA screening reduces mortality, Dr. Lin said.

Furthermore, treatment of low-risk disease is controversial, and data suggest that active surveillance is an acceptable strategy.

"Conversely, the treatment of intermediate- and high-risk disease has been supported by randomized, controlled trials, and there is a survival benefit for those men with intermediate- or high-risk disease," he said, noting that this underscores the importance of detecting high-grade disease.

The 4Kscore test addresses the controversies surrounding PSA screening and will address the concerns of policy makers who question prostate screening in general.

"The 4Kscore test yields superior performance to a clinical model based on the reduction of unnecessary biopsies and minimization of delay in diagnosing high-grade disease. The 4Kscore test is optimized for clinically relevant and actionable high-grade disease and can inform our decision making between the physician and patient, allowing for a unique personalization of risk. This will allow us to focus our efforts on treatment and evidence surrounding high-grade disease, which is clinically relevant," he concluded.

Funding for this study was provided by OPKO Diagnostics.

ORLANDO – A four kallikrein assay panel of human kallikrein and total, free, and intact prostate-specific antigen combined in an algorithm with age, digital rectal examination, and prior biopsy status provides a very high degree of discrimination for prostate cancer, compared with a PSA-based clinical algorithm, according to Dr. Daniel Lin.

The test (4Kscore test) was adapted from European studies which demonstrated that it is an accurate predictor of biopsy results, particularly for Gleason score 7 or greater disease, Dr. Lin of the University of Washington Medical Center, Seattle, reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

In a prospective, blinded study, calibration of the 4Kscore algorithm in the first 300 patients enrolled from October 2013 to January 2014 was nearly perfect, compared with the European version, showing that the score works on an individual level, he said.

At one illustrative cut point, the score would have reduced the number of biopsies by 41%, with a negative-predictive value of 97%.

The test is of value at the population level, as well.

For high-grade disease, the 4Kscore test had a "very high and very robust" area under the curve of 0.82.

"The best comparator might be the [Prostate Cancer Prevention Trial] risk calculator, which takes into account age, PSA, Gleason grade, race, prior biopsy status, and the rectal examination," Dr. Lin said, explaining that findings with the two scores were "clearly nonoverlapping."

Even in the high-grade disease with a PSA of 2-10 in the "diagnostic gray zone," the 4Kscore test showed superiority for discrimination of high-grade disease.

A decision analysis demonstrated that clinical decision-making would be improved by the use of the 4Kscore test, he said.

Study subjects were 1,300 men scheduled for biopsy at any of 26 U.S. urology centers. Following phlebotomy, participants underwent at least a 10-core transrectal ultrasound-guided biopsy. The first 300 patients represented a calibration cohort, and the remaining 1,000 are part of a validation cohort.

The findings are of note, because controversy exists with respect to the use of PSA screening.

"We all know there are several challenges surrounding the early detection of prostate cancer, and particularly screening with PSA," Dr. Lin said, noting that positive screens lead to unnecessary biopsies.

In fact, about 60% of initial biopsies are negative, and about half of those that are positive are low-grade, potentially indolent disease, he said.

This, along with the fact that biopsies can be associated with complications and patient anxiety, has led to a negative perception of PSA screening among some medical organizations such as the U.S. Preventive Services Task Force, which has recommended against PSA screening of healthy men, despite evidence that PSA screening reduces mortality, Dr. Lin said.

Furthermore, treatment of low-risk disease is controversial, and data suggest that active surveillance is an acceptable strategy.

"Conversely, the treatment of intermediate- and high-risk disease has been supported by randomized, controlled trials, and there is a survival benefit for those men with intermediate- or high-risk disease," he said, noting that this underscores the importance of detecting high-grade disease.

The 4Kscore test addresses the controversies surrounding PSA screening and will address the concerns of policy makers who question prostate screening in general.

"The 4Kscore test yields superior performance to a clinical model based on the reduction of unnecessary biopsies and minimization of delay in diagnosing high-grade disease. The 4Kscore test is optimized for clinically relevant and actionable high-grade disease and can inform our decision making between the physician and patient, allowing for a unique personalization of risk. This will allow us to focus our efforts on treatment and evidence surrounding high-grade disease, which is clinically relevant," he concluded.

Funding for this study was provided by OPKO Diagnostics.

ORLANDO – A four kallikrein assay panel of human kallikrein and total, free, and intact prostate-specific antigen combined in an algorithm with age, digital rectal examination, and prior biopsy status provides a very high degree of discrimination for prostate cancer, compared with a PSA-based clinical algorithm, according to Dr. Daniel Lin.

The test (4Kscore test) was adapted from European studies which demonstrated that it is an accurate predictor of biopsy results, particularly for Gleason score 7 or greater disease, Dr. Lin of the University of Washington Medical Center, Seattle, reported during a late-breaking abstract session at the annual meeting of the American Urological Association.

In a prospective, blinded study, calibration of the 4Kscore algorithm in the first 300 patients enrolled from October 2013 to January 2014 was nearly perfect, compared with the European version, showing that the score works on an individual level, he said.

At one illustrative cut point, the score would have reduced the number of biopsies by 41%, with a negative-predictive value of 97%.

The test is of value at the population level, as well.

For high-grade disease, the 4Kscore test had a "very high and very robust" area under the curve of 0.82.

"The best comparator might be the [Prostate Cancer Prevention Trial] risk calculator, which takes into account age, PSA, Gleason grade, race, prior biopsy status, and the rectal examination," Dr. Lin said, explaining that findings with the two scores were "clearly nonoverlapping."

Even in the high-grade disease with a PSA of 2-10 in the "diagnostic gray zone," the 4Kscore test showed superiority for discrimination of high-grade disease.

A decision analysis demonstrated that clinical decision-making would be improved by the use of the 4Kscore test, he said.

Study subjects were 1,300 men scheduled for biopsy at any of 26 U.S. urology centers. Following phlebotomy, participants underwent at least a 10-core transrectal ultrasound-guided biopsy. The first 300 patients represented a calibration cohort, and the remaining 1,000 are part of a validation cohort.

The findings are of note, because controversy exists with respect to the use of PSA screening.

"We all know there are several challenges surrounding the early detection of prostate cancer, and particularly screening with PSA," Dr. Lin said, noting that positive screens lead to unnecessary biopsies.

In fact, about 60% of initial biopsies are negative, and about half of those that are positive are low-grade, potentially indolent disease, he said.

This, along with the fact that biopsies can be associated with complications and patient anxiety, has led to a negative perception of PSA screening among some medical organizations such as the U.S. Preventive Services Task Force, which has recommended against PSA screening of healthy men, despite evidence that PSA screening reduces mortality, Dr. Lin said.

Furthermore, treatment of low-risk disease is controversial, and data suggest that active surveillance is an acceptable strategy.

"Conversely, the treatment of intermediate- and high-risk disease has been supported by randomized, controlled trials, and there is a survival benefit for those men with intermediate- or high-risk disease," he said, noting that this underscores the importance of detecting high-grade disease.

The 4Kscore test addresses the controversies surrounding PSA screening and will address the concerns of policy makers who question prostate screening in general.

"The 4Kscore test yields superior performance to a clinical model based on the reduction of unnecessary biopsies and minimization of delay in diagnosing high-grade disease. The 4Kscore test is optimized for clinically relevant and actionable high-grade disease and can inform our decision making between the physician and patient, allowing for a unique personalization of risk. This will allow us to focus our efforts on treatment and evidence surrounding high-grade disease, which is clinically relevant," he concluded.

Funding for this study was provided by OPKO Diagnostics.

ORLANDO – Tumors detected following prostate-specific antigen screening in black men aged 40-54 years had more favorable clinico-pathologic characteristics than those detected in black men aged 55-70 years, according to a study of more than 2,700 veterans.

The findings provide clinical support for the recommendation that black men who desire prostate cancer screening undergo prostate-specific antigen (PSA) testing at an earlier age than is suggested for white men – a recommendation based primarily on observed racial disparities in prostate cancer outcomes for men older than 50 years of age, Amanda Saltzman, Pharm.D., reported at the annual meeting of the American Urological Association.

Among the observed racial disparities in outcomes are higher tumor grade, greater likelihood of nonlocalized disease, and advanced-stage prostate cancer at diagnosis, as well as higher tumor volume in prostatectomy specimens, higher index PSA levels, younger age at diagnosis, lower likelihood of low-risk prognostic data, and higher mortality. However, it has been unclear whether earlier testing confers a survival benefit, she said.

In the current study, Dr. Saltzman and her colleagues sought to determine whether the diagnosis of tumors with characteristics associated with increased mortality was less likely in black men tested at ages 40-54 years, compared with those tested at ages 55-70 years, and compared with white men tested at ages 40-54 years in an "equal insurance coverage system," Dr. Saltzman of Louisiana State University, New Orleans explained during a press briefing at the meeting.

The men were part of a cohort of more than 231,000 otherwise healthy veterans aged 40-70 years who underwent PSA testing between October 2000 and September 2007. A total of 1,044 black veterans and 1,700 white veterans were diagnosed with prostate cancer. A total of 397 black men aged 40-54 years were compared with 647 black men aged 55-70 years and with the white veterans aged 40-54 years.

No difference was seen between the younger and older black cohort with respect to prebiopsy PSA. For example, 9.3% and 9.4% of men in the groups, respectively, had PSA greater than 20 ng/mL.

"When we looked at our young black cohort and our white cohort, however, there was a statistically significant difference, with our blacks having a higher index PSA [9.3% younger blacks vs. 6% whites had PSA greater than 20 ng/mL]. When we looked at biopsy Gleason sums, there was a significant difference between our older blacks and our younger blacks, with our older blacks tending to have higher Gleason scores than the younger blacks [15% vs. 12% had scores greater than eight, for example]," Dr. Saltzman said.

There was no difference between the young black veterans and the white veterans in Gleason scores, and no difference between any of the groups with respect to tumor stage.

In the older blacks, there was a nonsignificant trend toward higher risk, compared with younger blacks.

"This trend persisted ... with our younger black men tending to be at higher risk than our white veterans," she noted.

"PSA testing of black men younger than age 55 provides a benefit specifically with respect to Gleason score at diagnosis. We know that Gleason sum strongly predicts disease-free survival in men with clinical localized disease. In contrast to prior general population studies, we did not observe any racial disparities with respect to clinical stage, tumor grade, or D’Amicorisk stratification for prostate cancer in veterans aged 40-54, so our equal insurance coverage seems to have eliminated some of the previously reported disparities," she said, adding that she and her colleagues hope to further explore whether earlier testing reduces prostate cancer deaths in blacks, and whether equal insurance coverage and equal access to screening and detection tools eliminates previously reported racial disparities in prostate cancer death.

The current findings provide the first evidence to support the current recommendations for screening at an earlier age in black men, she concluded, adding: "I would definitely advocate for screening black men early. The specific age is unclear, but certainly before age 55."

Dr. Saltzman reported having no disclosures.

ORLANDO – Tumors detected following prostate-specific antigen screening in black men aged 40-54 years had more favorable clinico-pathologic characteristics than those detected in black men aged 55-70 years, according to a study of more than 2,700 veterans.

The findings provide clinical support for the recommendation that black men who desire prostate cancer screening undergo prostate-specific antigen (PSA) testing at an earlier age than is suggested for white men – a recommendation based primarily on observed racial disparities in prostate cancer outcomes for men older than 50 years of age, Amanda Saltzman, Pharm.D., reported at the annual meeting of the American Urological Association.

Among the observed racial disparities in outcomes are higher tumor grade, greater likelihood of nonlocalized disease, and advanced-stage prostate cancer at diagnosis, as well as higher tumor volume in prostatectomy specimens, higher index PSA levels, younger age at diagnosis, lower likelihood of low-risk prognostic data, and higher mortality. However, it has been unclear whether earlier testing confers a survival benefit, she said.

In the current study, Dr. Saltzman and her colleagues sought to determine whether the diagnosis of tumors with characteristics associated with increased mortality was less likely in black men tested at ages 40-54 years, compared with those tested at ages 55-70 years, and compared with white men tested at ages 40-54 years in an "equal insurance coverage system," Dr. Saltzman of Louisiana State University, New Orleans explained during a press briefing at the meeting.

The men were part of a cohort of more than 231,000 otherwise healthy veterans aged 40-70 years who underwent PSA testing between October 2000 and September 2007. A total of 1,044 black veterans and 1,700 white veterans were diagnosed with prostate cancer. A total of 397 black men aged 40-54 years were compared with 647 black men aged 55-70 years and with the white veterans aged 40-54 years.

No difference was seen between the younger and older black cohort with respect to prebiopsy PSA. For example, 9.3% and 9.4% of men in the groups, respectively, had PSA greater than 20 ng/mL.

"When we looked at our young black cohort and our white cohort, however, there was a statistically significant difference, with our blacks having a higher index PSA [9.3% younger blacks vs. 6% whites had PSA greater than 20 ng/mL]. When we looked at biopsy Gleason sums, there was a significant difference between our older blacks and our younger blacks, with our older blacks tending to have higher Gleason scores than the younger blacks [15% vs. 12% had scores greater than eight, for example]," Dr. Saltzman said.

There was no difference between the young black veterans and the white veterans in Gleason scores, and no difference between any of the groups with respect to tumor stage.

In the older blacks, there was a nonsignificant trend toward higher risk, compared with younger blacks.

"This trend persisted ... with our younger black men tending to be at higher risk than our white veterans," she noted.

"PSA testing of black men younger than age 55 provides a benefit specifically with respect to Gleason score at diagnosis. We know that Gleason sum strongly predicts disease-free survival in men with clinical localized disease. In contrast to prior general population studies, we did not observe any racial disparities with respect to clinical stage, tumor grade, or D’Amicorisk stratification for prostate cancer in veterans aged 40-54, so our equal insurance coverage seems to have eliminated some of the previously reported disparities," she said, adding that she and her colleagues hope to further explore whether earlier testing reduces prostate cancer deaths in blacks, and whether equal insurance coverage and equal access to screening and detection tools eliminates previously reported racial disparities in prostate cancer death.

The current findings provide the first evidence to support the current recommendations for screening at an earlier age in black men, she concluded, adding: "I would definitely advocate for screening black men early. The specific age is unclear, but certainly before age 55."

Dr. Saltzman reported having no disclosures.

ORLANDO – Tumors detected following prostate-specific antigen screening in black men aged 40-54 years had more favorable clinico-pathologic characteristics than those detected in black men aged 55-70 years, according to a study of more than 2,700 veterans.

The findings provide clinical support for the recommendation that black men who desire prostate cancer screening undergo prostate-specific antigen (PSA) testing at an earlier age than is suggested for white men – a recommendation based primarily on observed racial disparities in prostate cancer outcomes for men older than 50 years of age, Amanda Saltzman, Pharm.D., reported at the annual meeting of the American Urological Association.

Among the observed racial disparities in outcomes are higher tumor grade, greater likelihood of nonlocalized disease, and advanced-stage prostate cancer at diagnosis, as well as higher tumor volume in prostatectomy specimens, higher index PSA levels, younger age at diagnosis, lower likelihood of low-risk prognostic data, and higher mortality. However, it has been unclear whether earlier testing confers a survival benefit, she said.

In the current study, Dr. Saltzman and her colleagues sought to determine whether the diagnosis of tumors with characteristics associated with increased mortality was less likely in black men tested at ages 40-54 years, compared with those tested at ages 55-70 years, and compared with white men tested at ages 40-54 years in an "equal insurance coverage system," Dr. Saltzman of Louisiana State University, New Orleans explained during a press briefing at the meeting.

The men were part of a cohort of more than 231,000 otherwise healthy veterans aged 40-70 years who underwent PSA testing between October 2000 and September 2007. A total of 1,044 black veterans and 1,700 white veterans were diagnosed with prostate cancer. A total of 397 black men aged 40-54 years were compared with 647 black men aged 55-70 years and with the white veterans aged 40-54 years.

No difference was seen between the younger and older black cohort with respect to prebiopsy PSA. For example, 9.3% and 9.4% of men in the groups, respectively, had PSA greater than 20 ng/mL.

"When we looked at our young black cohort and our white cohort, however, there was a statistically significant difference, with our blacks having a higher index PSA [9.3% younger blacks vs. 6% whites had PSA greater than 20 ng/mL]. When we looked at biopsy Gleason sums, there was a significant difference between our older blacks and our younger blacks, with our older blacks tending to have higher Gleason scores than the younger blacks [15% vs. 12% had scores greater than eight, for example]," Dr. Saltzman said.

There was no difference between the young black veterans and the white veterans in Gleason scores, and no difference between any of the groups with respect to tumor stage.

In the older blacks, there was a nonsignificant trend toward higher risk, compared with younger blacks.

"This trend persisted ... with our younger black men tending to be at higher risk than our white veterans," she noted.

"PSA testing of black men younger than age 55 provides a benefit specifically with respect to Gleason score at diagnosis. We know that Gleason sum strongly predicts disease-free survival in men with clinical localized disease. In contrast to prior general population studies, we did not observe any racial disparities with respect to clinical stage, tumor grade, or D’Amicorisk stratification for prostate cancer in veterans aged 40-54, so our equal insurance coverage seems to have eliminated some of the previously reported disparities," she said, adding that she and her colleagues hope to further explore whether earlier testing reduces prostate cancer deaths in blacks, and whether equal insurance coverage and equal access to screening and detection tools eliminates previously reported racial disparities in prostate cancer death.

The current findings provide the first evidence to support the current recommendations for screening at an earlier age in black men, she concluded, adding: "I would definitely advocate for screening black men early. The specific age is unclear, but certainly before age 55."

Dr. Saltzman reported having no disclosures.