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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 c…