Study Suggests Radical Prostatectomy Does Not Significantly Reduce All-Cause or Prostate-Cancer Mortality
The treatment of early-stage prostate cancer remains controversial, especially for tumors detected by means of prostate-specific antigen (PSA) testing. Moreover, although the lifetime risk of receiving a diagnosis of prostate cancer is about 17%, the risk of dying from the disease is approximately 3%, suggesting that conservative management may be appropriate for many men. This randomized trial compared radical prostatectomy with observation in 731 men who had received a diagnosis of clinically localized prostate cancer in the early era of PSA testing. Enrollment of patients in this study began in 11/94 and ended in 1/02, with follow-up through 1/10. Patients were recruited from 44 VAMCs and 8 National Cancer Institute (NCI) sites. Study visits were scheduled every six months for a minimum of 8 years and a maximum of 15 years, or until the patient died. Investigators analyzed death from any cause, death from prostate cancer or treatment (with death from other causes treated as a competing risk), and bone metastases.
- Among men with localized prostate cancer, which was detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate cancer mortality, as compared with observation, through at least 12 years. During the median follow-up of 10 years, 171 of 364 men (47%) assigned to radical prostatectomy died, compared with 183 of 367 men (50%) that were assigned to observation. Among men assigned to radical prostatectomy, 21 (6%) died from prostate cancer or treatment compared with 31 men (8%) assigned to observation.
- Sub-group analyses suggest that surgery might reduce mortality among men with higher PSA values and possibly among men with higher-risk tumors (absolute reductions in mortality between 7% and 13%), but not among men with PSA levels of 10 ng per milliliter or less, or among men with low-risk tumors.
- The effect of treatment on all-cause and prostate cancer mortality did not differ according to the patient's age, race, co-existing conditions, or self-reported performance status.
- Peri-operative complications during the first 30 days after surgery occurred in 21% of men who underwent a radical prostatectomy, and included one death.
The authors note that their study was conducted in the early era of PSA testing. Current practices of performing repeated PSA testing, using a lower threshold for biopsy, obtaining more tissue-biopsy cores, and performing a repeat biopsy after initially negative findings increase the detection of smaller-volume indolent cancers. Along with histologic upgrading, these factors increase the likelihood of over-diagnosis and over-treatment. As a result, potential benefits of prostatectomy would likely be even smaller for men with a current diagnosis of prostate cancer.
This study was supported by VA's Cooperative Studies Program, the NCI, and the Agency for Healthcare Research and Quality. Dr. Wilt is part of VA/HSR&D's Center for Chronic Disease Outcomes Research, Minneapolis, MN.
Wilt T, Brawer M, Jones K, et al. Radical Prostatectomy versus Observation for Localized Prostate Cancer. The New England Journal of Medicine July 19, 2012;367(3):203-13.