Prostatectomy of Mixed Mortality Benefit in Men With Cancer

By David Douglas

March 11, 2020

NEW YORK (Reuters Health) - Over decades, death from any cause is lower in some men who undergo radical prostatectomy but observation alone may be a better choice in others with prostate cancer, according to a long-term follow-up of a randomized trial.

As Dr. Timothy J. Wilt told Reuters Health by email, "While surgery may have important mortality benefits in men with long life expectancies having clinically detected, intermediate-risk, and possibly high-risk prostate cancer, our results, together with other treatment trials, provide convincing evidence that observation and PSA-based monitoring result in similar long-term mortality with less harm compared with surgery or radiation for men with PSA-detected low-risk prostate cancer and many with intermediate- or high-risk disease."

The trial included 731 men with localized prostate cancer who were 75 years or younger when they were randomized to radical prostatectomy or observation. Their prostate-specific antigen (PSA) level was below 50 ng/mL and their life expectancy was at least 10 years.

Over the course of 21.1 years, 246 of the 346 men assigned to surgery died compared to 269 of 367 assigned to observation (68% vs. 73%, P=0.044). The restricted mean survival time in the surgical group was 13.6 years compared to 12.6 years in the observation group (95% confidence interval, 0.0 to 2.0 years).

Results did not significantly vary by patient or tumor characteristics, but differences favoring surgery were greater in men who were white, aged less than 65 years and who had better health status.

Overall, say the researchers, "Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease."

"Early intervention results in morbidity and negatively impacts urinary, sexual, and erectile function, as well as physical comfort and activities of daily living," Dr. Wilt pointed out.

He concluded, "Clinicians should discuss these findings with their patients, and target early interventions to individuals needing and benefiting while reducing harms of ineffective treatments and/or overtreatment."

Dr. Jim C. Hu, a professor of urologic oncology at New York Presbyterian/Weill Cornell, in New York City, told Reuters Health by email, "The challenge of randomized trials for prostate cancer is the long period of time needed for meaningful differences to occur, and in turn, practice patterns change as we wait for these events."

"The authors note that the study was not powered for subgroup analysis and results should be interpreted with caution; however, this is the most meaningful way to look at this research," he added. "For instance, it is reassuring that surgery had no benefit for men with low-risk prostate cancer: at present most men with low-risk disease opt for active surveillance."

Also, he said, "white men were more likely to benefit from surgery versus blacks and others; surgery was more likely to be beneficial in younger men and those with no comorbid conditions."

Dr. Hu concluded, "taken together, surgery has a benefit in younger, healthy men, confirming the findings of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4)."

SOURCE: European Urology, online February 20, 2020.