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Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate
Timothy J Wilt1, Tien N Vo2, Lisa Langsetmo2
1Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA.
European Urology
|February 25, 2020
Summary
Radical prostatectomy surgery for early prostate cancer may offer a small, very long-term reduction in all-cause mortality compared to observation. This approach can increase life-years gained, particularly for men with intermediate-risk disease.
Area of Science:
- Urology
- Oncology
- Clinical Trials
Background:
- Uncertainty exists regarding very long-term mortality differences between surgery and observation for early prostate cancer.
- Early prostate cancer management requires evaluation of long-term outcomes.
Purpose of the Study:
- To determine the long-term effects of radical prostatectomy versus observation on all-cause mortality in men with early prostate cancer.
- To assess survival outcomes and life-years gained from surgical intervention compared to watchful waiting.
Main Methods:
- A randomized trial followed 731 men (≤75 years) with localized prostate cancer for a median of 18.6 years.
- Intention-to-treat analysis using Kaplan-Meier methods and Cox proportional hazard models assessed all-cause mortality.
- Evaluated cumulative incidence, risk differences, and relative risks between radical prostatectomy and observation groups.
Main Results:
- Over 22.1 years, 515 men died. Surgery (68% mortality) showed a trend towards lower mortality than observation (73%), with a hazard ratio of 0.84 (p=0.044).
- Surgery was associated with a mean gain of 1 life-year (restricted mean survival: 13.6 vs. 12.6 years).
- Benefits were more pronounced in younger men, white men, those with better health, and intermediate-risk disease, but not high-risk disease.
Conclusions:
- Radical prostatectomy is associated with small, very long-term reductions in all-cause mortality and increased life-years gained.
- Absolute survival benefits were smaller in low-risk disease but greater in intermediate-risk disease.
- Strategies are needed to identify men who will benefit from surgery, avoiding overtreatment.

