PIVOT Prostate Cancer Study Should Empower Men to Make Informed Decisions

An important study was published in the New England Journal of Medicine (NEJM) that addresses the use of the prostate-specific antigen test, or PSA test, for early detection and the challenges regarding proper early detection and early treatment of prostate cancer in the PSA era.

The results concern the Prostate Cancer Intervention Versus Observation Trial, or PIVOT study — a randomized controlled trial sponsored by the U.S. Department of Veterans Affairs (VA) and the National Cancer Institute (NCI). The study set out to determine which of two strategies — radical prostatectomy (surgery to remove the prostate) or observation — is superior for managing clinically localized prostate cancer.

From 1994 to 2002, researchers at the VA and eight NCI-designated cancer centers randomly assigned 731 men with localized prostate cancer to either radical prostatectomy or observation and followed them over 12 years.

They concluded that, compared to observation, radical prostatectomy did not significantly reduce mortality through at least 12 years of follow-up. Surgery was associated with lower mortality for some men, however — primarily in those with relatively high PSA values and those with aggressive (intermediate or high-risk) disease.

So, should we stop doing prostatectomies? Absolutely not. There are still many men for whom surgery to remove the prostate is the appropriate treatment option, and it’s important to note that the population of men studied in this trial was skewed toward older men who are in poor health.

The PIVOT trial should empower men with less aggressive cancers to say, “I can feel good about watching my PSA carefully and foregoing treatment, at least for now.” And it should tell urologists and radiation oncologists to be more selective about whom they’re recommending treatment for.

The study, available here, is “Radical Prostatectomy versus Observation for Localized Prostate Cancer” by Timothy J. Wilt, MD, MPH, of the Center for Chronic Disease Outcomes Research, U.S. Department of Veterans Affairs, and co-authors.

To read a longer commentary I wrote about this study and its implications, click here.