Prostate Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage II Prostate Cancer Treatment
Evidence (radical prostatectomy compared with watchful waiting):
Radical prostatectomy has been compared with watchful waiting or active surveillance in men with early-stage disease (clinical stages T1b, T1c, or T2) in a randomized clinical trial performed in Sweden in the pre-PSA screening era.[14,15] Only about 5% of the men in the trial had been diagnosed by PSA screening.
The cumulative overall mortality at 15 years in the radical-prostatectomy and watchful-waiting study arms was 46.1% and 52.7%, respectively (absolute difference, 6.6%; 95% CI, -1.3–14.5; relative risk [RR]death of 0.75; 95% CI, 0.61–0.92).[Level of evidence: 1iiA]
The cumulative incidence of prostate cancer deaths at 15 years was 14.6% versus 20.7% (absolute difference, 6.1%; 95% CI, 0.2–12.0; RRdeath from prostate cancer, 0.62; 95% CI, 0.44–0.87).
In a post-hoc–subset analysis, the improvement in overall and prostate cancer-specific mortality associated with radical prostatectomy was restricted to men younger than 65 years.
The Prostate Intervention Versus Observation Trial (PIVOT) is the only published randomized trial conducted in the PSA screening era that directly compared radical prostatectomy with watchful waiting. From November 1994 through January 2002, 731 men aged 75 years or younger with localized prostate cancer (stage T1–2, NX, M0, with a blood PSA <50 ng/ml) and a life expectancy of at least 10 years were randomly assigned to radical prostatectomy versus watchful waiting.[Levels of evidence: 1iiA, 1iiB]
About 50% of the men had palpable tumors.
After a median follow-up of 10 years (range up to about 15 years), the all-cause mortality was 47.0% versus 49.9% in the radical-prostatectomy and watchful-waiting study arms, respectively, a difference that was not statistically significant (HR, 0.88; 95% CI, 0.71–1.08; P = .22). Prostate cancer-specific mortality was 5.8% versus 8.4%, and it also was not statistically significant (HR, 0.63; 95% CI, 0.36–1.09; P = .09).
Subgroup analyses showed a statistically significant reduction in overall mortality in the group of men with a baseline PSA greater than 10 ng/ml (61 of 126 men vs. 77 of 125 men; HR, 0.67) but no difference in men with a PSA of 10 ng/ml or less (110 of 238 men vs. 101 of 241 men; HR, 1.03; P for interaction = .04). Because the test for interaction was not adjusted for the numerous subgroup comparisons, it should be interpreted with caution.
Although there was a trend favoring prostatectomy, for prostate cancer-specific mortality, in men with a PSA greater than 10, the numbers were very small (7 of 126 men vs. 16 of 125 men for a PSA >10 ng/ml; 14 of 238 men vs. 15 of 241 men with lower PSA levels), and the interaction with the PSA level was not statistically significant ( P = .11). There were no statistically significant differences in efficacy associated with prostatectomy by age (< 65 years vs. ≥ 65 years), Gleason score, Charlson comorbidity status, race, or performance score.