LINTHICUM, MD, July 23, 2012 – In response to new data from the Prostate Cancer Intervention vs. Observation Trial (PIVOT) released today in the New England Journal of Medicine, the American Urological Association (AUA) released the following statement, attributable to the AUA Chair of Health Policy David F. Penson, MD, MPH, a prostate cancer expert at Vanderbilt University:
“Though on the surface, these new data from PIVOT may imply that radical prostatectomy did not significantly reduce mortality in men with localized prostate cancer when compared with observation, the data do show a demonstrated positive effect in prostate cancer-specific mortality (as well as a trend in overall mortality) in high-risk patients. This trend is evident, despite the fact that PIVOT is an undersized study (its enrollment of 731 men is not large enough to give an adequate confidence interval) and suffers from other flaws that impact its ability to fully assess the effects of treatment. Had study enrollment been larger, this trend would be even more significant.
In this study, radical prostatectomy was shown to have little benefit in men with low-risk disease when compared to observation. These data corroborate additional models (such as those developed by CISNET investigators) suggesting potential overtreatment, and further reiterating belief that not all men require active treatment for their prostate cancers. However, the positive findings in the high-risk patients underscore a strong need for reliable, effective biomarkers that allow us to distinguish low-risk disease from high-risk disease so we can prescribe treatment accordingly. Until we are able to distinguish between indolent and aggressive disease, some men with low-risk prostate cancer will desire treatment; this is appropriate in the absence of a certainty that they will die with prostate cancer, not of prostate cancer.
While the study demonstrates that some men with low-grade disease may not benefit from surgical intervention, it is does not add to our understanding of who exactly these men are. This is due, in no small part, to the fact that only 10 percent of the men in PIVOT were under age 60 and only half of the patients (55 percent) had no other co-morbid conditions. Given that the median follow-up in PIVOT was only 10 years and the real possibility that patients with low-grade prostate cancer and longer life-expectancies may garner some benefit from surgical treatment with longer follow-up, younger, healthier patients with low-grade prostate cancer should still strongly consider surgical treatment for their disease.”
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 18,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.
Wendy Waldsachs Isett, AUA