AUA Annual Meeting 2013

A new practice guideline released at the American Urological Association annual meeting presents the clinical framework to help weigh the risks and benefits of providing adjuvant and salvage radiation therapy after prostatectomy.

"There is now a document that guides us in offering the best clinical practices for anyone who undergoes radical prostatectomy regarding their follow-up care with radiotherapy," said Dr. Richard K. Valicenti of the department of radiation oncology at the University of California, Davis.

One practice standard in the guideline advises physicians to offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy, because studies have shown that this therapy can result in reductions in prostate-specific antigen (PSA) recurrence, local recurrence, and clinical progression. The adverse findings that would warrant this therapy include seminal vesicle invasion, positive surgical margins, or extraprostatic extension.

"The data are overwhelmingly consistent that it [radiotherapy] will improve on tumor control rates, as well as progression-free survival," Dr. Valicenti said, adding that these patients should also experience improved quality of life.

In addition to the above practice standard, the guideline, issued jointly by the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA), made the following recommendations:

• Inform patients with localized prostate cancer considering radical prostatectomy about the possibility that the pathologic findings will predict a higher risk of cancer recurrence.

• Advise patients with adverse pathologic findings, including seminal vesicle invasion, positive surgical margins, and extraprostatic extension, that adjuvant radiation therapy compared with radical prostatectomy only reduces the risk of PSA recurrence, local recurrence, and clinical progression of cancer;

• Warn patients that they are a higher risk of developing metastatic prostate cancer or death from the disease if there is a PSA recurrence after surgery;

• Define biochemical recurrence as a detectable or rising PSA value after surgery that is greater than or equal to 0.2 ng/mL with a second confirmatory level greater than or equal to 0.2 ng/mL.

• Consider a restaging evaluation in patients with a PSA recurrence.

• Offer salvage radiation therapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease.

• Inform patients that the effectiveness of radiation therapy for PSA recurrence is greatest when given at lower levels of PSA. and

• Inform patients that in addition to the benefits of controlling disease recurrence, radiation therapy could produce possible short- and long-term urinary, bowel, and sexual side effects.

Before recommending adjuvant or salvage radiotherapy, "look at the patients’ biological information obtained from the radical prostatectomy specimen, and balance that with the overall health status of the patients [and] concerns about certain aspects of quality of life, whether it be sexual activity or urinary function. They also need to balance that with any other medical conditions or previous treatments that would preclude the use of radiation therapy," Dr. Valicenti said.

"The Adjuvant and Salvage Radiotherapy After Prostatectomy: ASTRO/AUA Guideline" is a comprehensive review of 324 research articles on patients with detectable and undetectable PSA levels, toxicity, optimal imaging strategies, and the impact on quality of life to determine the appropriateness of radiation therapy in patients suspected of recurrence. Only studies in which PSA data were provided for at least 75% of patients were included in the guideline. The panel was led by Dr. Valicenti and Dr. Ian M. Thompson of the University of Texas Health Science Center.

The guideline is available at www.redjournal.org and www.auanet.org.

Dr. Valicenti reported no relevant disclosures.

A new practice guideline released at the American Urological Association annual meeting presents the clinical framework to help weigh the risks and benefits of providing adjuvant and salvage radiation therapy after prostatectomy.

"There is now a document that guides us in offering the best clinical practices for anyone who undergoes radical prostatectomy regarding their follow-up care with radiotherapy," said Dr. Richard K. Valicenti of the department of radiation oncology at the University of California, Davis.

One practice standard in the guideline advises physicians to offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy, because studies have shown that this therapy can result in reductions in prostate-specific antigen (PSA) recurrence, local recurrence, and clinical progression. The adverse findings that would warrant this therapy include seminal vesicle invasion, positive surgical margins, or extraprostatic extension.

"The data are overwhelmingly consistent that it [radiotherapy] will improve on tumor control rates, as well as progression-free survival," Dr. Valicenti said, adding that these patients should also experience improved quality of life.

In addition to the above practice standard, the guideline, issued jointly by the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA), made the following recommendations:

• Inform patients with localized prostate cancer considering radical prostatectomy about the possibility that the pathologic findings will predict a higher risk of cancer recurrence.

• Advise patients with adverse pathologic findings, including seminal vesicle invasion, positive surgical margins, and extraprostatic extension, that adjuvant radiation therapy compared with radical prostatectomy only reduces the risk of PSA recurrence, local recurrence, and clinical progression of cancer;

• Warn patients that they are a higher risk of developing metastatic prostate cancer or death from the disease if there is a PSA recurrence after surgery;

• Define biochemical recurrence as a detectable or rising PSA value after surgery that is greater than or equal to 0.2 ng/mL with a second confirmatory level greater than or equal to 0.2 ng/mL.

• Consider a restaging evaluation in patients with a PSA recurrence.

• Offer salvage radiation therapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease.

• Inform patients that the effectiveness of radiation therapy for PSA recurrence is greatest when given at lower levels of PSA. and

• Inform patients that in addition to the benefits of controlling disease recurrence, radiation therapy could produce possible short- and long-term urinary, bowel, and sexual side effects.

Before recommending adjuvant or salvage radiotherapy, "look at the patients’ biological information obtained from the radical prostatectomy specimen, and balance that with the overall health status of the patients [and] concerns about certain aspects of quality of life, whether it be sexual activity or urinary function. They also need to balance that with any other medical conditions or previous treatments that would preclude the use of radiation therapy," Dr. Valicenti said.

"The Adjuvant and Salvage Radiotherapy After Prostatectomy: ASTRO/AUA Guideline" is a comprehensive review of 324 research articles on patients with detectable and undetectable PSA levels, toxicity, optimal imaging strategies, and the impact on quality of life to determine the appropriateness of radiation therapy in patients suspected of recurrence. Only studies in which PSA data were provided for at least 75% of patients were included in the guideline. The panel was led by Dr. Valicenti and Dr. Ian M. Thompson of the University of Texas Health Science Center.

The guideline is available at www.redjournal.org and www.auanet.org.

Dr. Valicenti reported no relevant disclosures.

A new practice guideline released at the American Urological Association annual meeting presents the clinical framework to help weigh the risks and benefits of providing adjuvant and salvage radiation therapy after prostatectomy.

"There is now a document that guides us in offering the best clinical practices for anyone who undergoes radical prostatectomy regarding their follow-up care with radiotherapy," said Dr. Richard K. Valicenti of the department of radiation oncology at the University of California, Davis.

One practice standard in the guideline advises physicians to offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy, because studies have shown that this therapy can result in reductions in prostate-specific antigen (PSA) recurrence, local recurrence, and clinical progression. The adverse findings that would warrant this therapy include seminal vesicle invasion, positive surgical margins, or extraprostatic extension.

"The data are overwhelmingly consistent that it [radiotherapy] will improve on tumor control rates, as well as progression-free survival," Dr. Valicenti said, adding that these patients should also experience improved quality of life.

In addition to the above practice standard, the guideline, issued jointly by the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA), made the following recommendations:

• Inform patients with localized prostate cancer considering radical prostatectomy about the possibility that the pathologic findings will predict a higher risk of cancer recurrence.

• Advise patients with adverse pathologic findings, including seminal vesicle invasion, positive surgical margins, and extraprostatic extension, that adjuvant radiation therapy compared with radical prostatectomy only reduces the risk of PSA recurrence, local recurrence, and clinical progression of cancer;

• Warn patients that they are a higher risk of developing metastatic prostate cancer or death from the disease if there is a PSA recurrence after surgery;

• Define biochemical recurrence as a detectable or rising PSA value after surgery that is greater than or equal to 0.2 ng/mL with a second confirmatory level greater than or equal to 0.2 ng/mL.

• Consider a restaging evaluation in patients with a PSA recurrence.

• Offer salvage radiation therapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease.

• Inform patients that the effectiveness of radiation therapy for PSA recurrence is greatest when given at lower levels of PSA. and

• Inform patients that in addition to the benefits of controlling disease recurrence, radiation therapy could produce possible short- and long-term urinary, bowel, and sexual side effects.

Before recommending adjuvant or salvage radiotherapy, "look at the patients’ biological information obtained from the radical prostatectomy specimen, and balance that with the overall health status of the patients [and] concerns about certain aspects of quality of life, whether it be sexual activity or urinary function. They also need to balance that with any other medical conditions or previous treatments that would preclude the use of radiation therapy," Dr. Valicenti said.

"The Adjuvant and Salvage Radiotherapy After Prostatectomy: ASTRO/AUA Guideline" is a comprehensive review of 324 research articles on patients with detectable and undetectable PSA levels, toxicity, optimal imaging strategies, and the impact on quality of life to determine the appropriateness of radiation therapy in patients suspected of recurrence. Only studies in which PSA data were provided for at least 75% of patients were included in the guideline. The panel was led by Dr. Valicenti and Dr. Ian M. Thompson of the University of Texas Health Science Center.

The guideline is available at www.redjournal.org and www.auanet.org.

Dr. Valicenti reported no relevant disclosures.

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Of men given an ICD-9 diagnosis of erectile dysfunction, 25% receive any treatment for the condition.

Treatment frequency was higher in men who had low levels of testosterone (51% treated) and lower in those who had prostate cancer (15% treated). Treatment frequency did not vary significantly with other associated comorbidities, Dr. Brian T. Helfand said in a press briefing at the annual meeting of the American Urological Association.

Dr. Helfand of the department of urology at NorthShore University Health System in Evanston, Ill., and his associates used an IMS data set to identify 6,228,509 men over the age of 30 years who received an ICD-9 diagnosis of erectile dysfunction (ED) during a 12-month period that ended in July 2011. IMS is a large insurance claims data set that encompasses more than 80% of prescription data in the United States.

Men were classified as treated if they filled a prescription for a phosphodiesterase type-5 (PDE5) inhibitor, injection or urethral prostaglandins, or androgen replacement therapy. They were classified as untreated if they received an ED diagnosis but did not fill a prescription in the study period. The researchers monitored the therapies by prescription frequency, age, comorbidities, and physician specialty.

Among the 25% of men who filled prescriptions, PDE5 was the most commonly prescribed medication (75%), followed by androgen replacement therapy (31%). Fewer than 2% of patients used any prostaglandin therapy. "The men who were in the oldest age groups were the least likely to fill a prescription," Dr. Helfand said.

The greatest proportion of prescriptions overall were ordered by primary care physicians (28%), followed by endocrinologists (27%), and urologists (21%). The remaining 24% were ordered by various other clinicians.

Dr. Helfand said limitations of the study include the exclusion of Medicare data plus lack of information about the severity of ED, efficacy of treatments, and adherence to long-term therapy.

Dr. Ajay Nangia, who is an associate professor of urology at the University of Kansas Medical Center and the moderator of the press briefing, noted that ED is a medical disease that is often a portent of other disorders. Recognizing that men with ED go untreated may mean that they’re also possibly underinvestigated for associated condition such as diabetes, lipid disorders, and risk factors such as smoking.

Dr. Helfand said that he had no relevant financial conflicts to disclose. One of the study authors, Dr. Kevin McVary, disclosed consultant, advisory, or other roles with several companies, including Allergan, Lilly, NxThera, Watson, NeoTract, and GSK.

dbrunk@frontlinemedcom.com

SAN DIEGO – Of men given an ICD-9 diagnosis of erectile dysfunction, 25% receive any treatment for the condition.

Treatment frequency was higher in men who had low levels of testosterone (51% treated) and lower in those who had prostate cancer (15% treated). Treatment frequency did not vary significantly with other associated comorbidities, Dr. Brian T. Helfand said in a press briefing at the annual meeting of the American Urological Association.

Dr. Helfand of the department of urology at NorthShore University Health System in Evanston, Ill., and his associates used an IMS data set to identify 6,228,509 men over the age of 30 years who received an ICD-9 diagnosis of erectile dysfunction (ED) during a 12-month period that ended in July 2011. IMS is a large insurance claims data set that encompasses more than 80% of prescription data in the United States.

Men were classified as treated if they filled a prescription for a phosphodiesterase type-5 (PDE5) inhibitor, injection or urethral prostaglandins, or androgen replacement therapy. They were classified as untreated if they received an ED diagnosis but did not fill a prescription in the study period. The researchers monitored the therapies by prescription frequency, age, comorbidities, and physician specialty.

Among the 25% of men who filled prescriptions, PDE5 was the most commonly prescribed medication (75%), followed by androgen replacement therapy (31%). Fewer than 2% of patients used any prostaglandin therapy. "The men who were in the oldest age groups were the least likely to fill a prescription," Dr. Helfand said.

The greatest proportion of prescriptions overall were ordered by primary care physicians (28%), followed by endocrinologists (27%), and urologists (21%). The remaining 24% were ordered by various other clinicians.

Dr. Helfand said limitations of the study include the exclusion of Medicare data plus lack of information about the severity of ED, efficacy of treatments, and adherence to long-term therapy.

Dr. Ajay Nangia, who is an associate professor of urology at the University of Kansas Medical Center and the moderator of the press briefing, noted that ED is a medical disease that is often a portent of other disorders. Recognizing that men with ED go untreated may mean that they’re also possibly underinvestigated for associated condition such as diabetes, lipid disorders, and risk factors such as smoking.

Dr. Helfand said that he had no relevant financial conflicts to disclose. One of the study authors, Dr. Kevin McVary, disclosed consultant, advisory, or other roles with several companies, including Allergan, Lilly, NxThera, Watson, NeoTract, and GSK.

dbrunk@frontlinemedcom.com

SAN DIEGO – Of men given an ICD-9 diagnosis of erectile dysfunction, 25% receive any treatment for the condition.

Treatment frequency was higher in men who had low levels of testosterone (51% treated) and lower in those who had prostate cancer (15% treated). Treatment frequency did not vary significantly with other associated comorbidities, Dr. Brian T. Helfand said in a press briefing at the annual meeting of the American Urological Association.

Dr. Helfand of the department of urology at NorthShore University Health System in Evanston, Ill., and his associates used an IMS data set to identify 6,228,509 men over the age of 30 years who received an ICD-9 diagnosis of erectile dysfunction (ED) during a 12-month period that ended in July 2011. IMS is a large insurance claims data set that encompasses more than 80% of prescription data in the United States.

Men were classified as treated if they filled a prescription for a phosphodiesterase type-5 (PDE5) inhibitor, injection or urethral prostaglandins, or androgen replacement therapy. They were classified as untreated if they received an ED diagnosis but did not fill a prescription in the study period. The researchers monitored the therapies by prescription frequency, age, comorbidities, and physician specialty.

Among the 25% of men who filled prescriptions, PDE5 was the most commonly prescribed medication (75%), followed by androgen replacement therapy (31%). Fewer than 2% of patients used any prostaglandin therapy. "The men who were in the oldest age groups were the least likely to fill a prescription," Dr. Helfand said.

The greatest proportion of prescriptions overall were ordered by primary care physicians (28%), followed by endocrinologists (27%), and urologists (21%). The remaining 24% were ordered by various other clinicians.

Dr. Helfand said limitations of the study include the exclusion of Medicare data plus lack of information about the severity of ED, efficacy of treatments, and adherence to long-term therapy.

Dr. Ajay Nangia, who is an associate professor of urology at the University of Kansas Medical Center and the moderator of the press briefing, noted that ED is a medical disease that is often a portent of other disorders. Recognizing that men with ED go untreated may mean that they’re also possibly underinvestigated for associated condition such as diabetes, lipid disorders, and risk factors such as smoking.

Dr. Helfand said that he had no relevant financial conflicts to disclose. One of the study authors, Dr. Kevin McVary, disclosed consultant, advisory, or other roles with several companies, including Allergan, Lilly, NxThera, Watson, NeoTract, and GSK.

dbrunk@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com