The PIVOT trial: Radical prostatectomy versus observation [Classics Series]

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1. Prostatectomy did not significantly reduce all-cause mortality or prostate-cancer mortality when compared to observation

2. These findings support conservative management for men with localized prostate cancer, especially for those with PSA values less than 10 ng/mL and low-risk disease

Original Date of Publication: July 19, 2012

Study Rundown: The incidence of prostate cancer in men is relatively high, but high long-term survival rates have been observed with conservative management. The treatment of localized prostate cancer is controversial as few trials have compared surgical intervention to observation in the time since prostate specific antigen (PSA) testing has become a common screening tool. This study found no significant difference in all-cause or prostate-cancer mortality following radical prostatectomy compared to observation. These findings suggest that observation is a safe strategy in managing localized prostate cancer and avoids the unnecessary risks of intervention. The results also show that PSA levels and tumour risk may be useful in identifying patients who will benefit from radical prostatectomy. Strengths of the study include the representative sample and measurement of all-cause mortality as the primary outcome which avoids biased assessments of cause-of-death. Of note, the study may have been underpowered as the investigators intended to enroll 2,000 participants, but reduced the sample size to 731. In addition, a substantial number of patients did not adhere to the assigned treatment in both groups, which could influence the observed treatment effect.

Please click to read study in NEJM

In-Depth [randomized, controlled study]: Published in NEJM in 2012, this randomized controlled trial assessed the effectiveness of surgery versus observation for men with localized prostate cancer. The trial included 731 men and followed participants for a median of 10 years. The primary outcome was all-cause mortality and a secondary outcome was prostate-cancer mortality, defined as death due to prostate cancer or prostate cancer treatment. The rate of all-cause mortality was not significantly different between the two groups with an absolute risk reduction of 2.9 percentage points in the radical-prostatectomy group. There was also no significant difference between groups in prostate cancer mortality. A significant interaction was found between study group and baseline PSA value. In men with a PSA value greater than 10 ng/mL, a significant reduction in all-cause mortality was observed with surgery, though surgery did not reduce all-cause mortality in men with a PSA less than or equal to 10 ng/mL.

By Adrienne Cheung, Andrew Cheung, M.D.

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