Prostatectomy vs. Observation for Prostate Cancer: PIVOT

Allan S. Brett, MD


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In This Article

Abstract and Introduction


Prostatectomy did not lower 10-year mortality overall; the exception was men with PSA levels >10 ng/mL.


Until now, no randomized trial has been designed to compare surgery with "watchful waiting" in patients with primarily prostate-specific antigen (PSA)-detected, localized prostate cancer. PIVOT (Prostate Cancer Intervention versus Observation Trial), conducted in the U.S., fills this gap.

The participants — 731 men with localized prostate cancer and life expectancy of at least 10 years — were randomized to radical prostatectomy or observation. Three quarters of cases were diagnosed through PSA screening, two thirds of men had PSA levels ≤10 ng/mL, and two thirds had Gleason scores <7. During the study, 10% of men in the observation group crossed over to prostatectomy.

At median follow-up of 10 years, neither all-cause mortality nor prostate cancer–specific mortality was significantly lower in the prostatectomy group than in the observation group. However, among men with PSA levels >10 ng/mL, mortality was lower with prostatectomy ( Table ). Subgroups with higher-risk cancers (defined by criteria incorporating PSA levels, Gleason scores, and tumor staging) also showed trends toward lower mortality with surgery. Bone metastases occurred in 4.7% of prostatectomy patients and in 10.6% of observation patients (P<0.001).