Radical prostatectomy RCT

Perhaps you’ve heard about the results of the latest randomized controlled trial (RCT) of radical prostatectomy for treatment of prostate cancer. It’s written up in the New England Journal of Medicine along with an editorial. Both are ungated. The editorial highlights the limitations of the study and is short. The full research article takes more time to read, and, my guess, is that many interested in this topic won’t.

However, Tara Parker-Pope did a good job in the New York Times laying out the results in a more accessible, summarized form and putting them in context. Her whole piece is worth reading, but here’s a portion:

The latest research, called the Prostate Cancer Intervention Versus Observation Trial, or Pivot, focuses on what happens after a man receives a diagnosis of early-stage cancer, often as a result of a P.S.A. test. The men in the study were randomly assigned either to surgical removal of the prostate or to an observation group, where a man’s cancer was monitored but not treated unless it showed signs of progressing. Although the study originally set out to recruit 2,000 men, the researchers could not reach that goal and revised the research plan to include 731 men.

By the end of the 15-year study, 354 men had died, but most of them had died of from a cause other than prostate cancer. There was no statistical difference in overall mortality rates in the surgical group, which had 171 deaths, compared with the observation group, which had 183 deaths.

During the study, only 52 men, or about 7 percent of the study subjects, died of prostate cancer, but again there was no statistical difference in the prostate cancer mortality rate between the groups.

But in a secondary analysis, the researchers did find an important difference between the groups, suggesting that surgery may benefit men with early-stage disease who have a high P.S.A. score. Among men with a P.S.A. value higher than 10 nanograms per milliliter of blood, surgery lowered a man’s risk of dying by 33 percent compared with the observation group. Overall, among men with high P.S.A. scores, there were 13 percent fewer deaths in the surgery group compared with the observation group. No difference was seen among men with a P.S.A. value of 10 or less.

The study was funded, in part by the Agency for Healthcare Research and Quality (AHRQ). The House is preparing to vote on terminating that agency.


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