Implications of the prostate intervention versus observation trial (PIVOT).

PSA screening improves early detection of prostate cancer but can lead to overtreatment if all of these cancers are treated. The first randomized treatment study for men with PSA detected cancers has now been reported. The PIVOT (prostatectomy intervention versus observation trial) results are noteworthy. There were no overall or cancer-specific survival benefits from radical prostatectomy versus observation. This result was primarily driven by the largest subset, men with ‘low risk’ prostate cancer (organ-confined, Gleason 6, and PSA ,10 ng ml-1). Even though men enrolled in PIVOT were older and sicker as compared to most radical prostatectomy series, there was a strong tendency toward improved prostate cancer specific survival for participants with a PSA .10 ng ml-1 or Gleason scores of 7 or higher. This important study underscores the benefits of observation for those with ‘low risk’ prostate cancer and the potential benefits of surgery for those in higher risk categories.

RCT Entities:   Population Interventions Outcomes