Figure 1. Scandinavian Prostate Cancer Group-4 (SPCG-4) study. Trial flow diagram of the 695 men randomly assigned in the SPCG-4 study. RT equals radiation therapy; RP equals radical prostatectomy. Copyright A. Bill-Axelson 2008. Published by Oxford University Press. All rights reserved.
In a post hoc subset analysis, there was a statistically significant difference in overall mortality favoring prostatectomy for men aged 65 and younger: 21.9% versus 40.2%, P = .004 (relative risk of death = 0.59; 95% confidence interval [CI], 0.41-0.85). In contrast, for men aged 65 years or older, the overall mortality at 12 years for the prostatectomy and watchful waiting arms was 42% versus 39.3%, P = 0.81; (relative risk of death = 1.04; 95% CI, 0.77-1.40). Overall prostate cancer-specific mortality in the full trial at 12 years favored prostatectomy: 12.5% versus 17.9%, P = 0.03; relative risk = 0.65; 95% CI; 0.45-0.94; see Figure 2.[Level of evidence: 1iiB]
Figure 2. Cumulative incidence with 95% confidence intervals (CIs) at 4, 8, and 12 years of endpoints for all patients. A) Overall mortality: relative risk (RR) equals 0.82; 95% CI, 0.65-1.03; P equals .09. B) Prostate cancer (PC) death: RR equals 0.65; 95% CI, 0.45-0.94; P equals .03. C) Metastases: RR equals 0.65; 95% CI, 0.47-0.88; P equals .006. D) Local progression: RR equals 0.36; 95% CI, 0.27-0.47; P less than .001. E) Hormonal treatment: RR equals 0.54; 95% CI, 0.44-0.68; P less than .001. F) Other palliative treatment: RR equals 0.63; 95% CI, 0.41-0.97; P equals .04. P values (two-sided) were calculated using Gray's test. Copyright A. Bill-Axelson 2008. Published by Oxford University Press. All rights reserved.
Results from the Prostate Intervention Versus Observation Trial (PIVOT-1), a randomized trial in the United States that compared radical prostatectomy with watchful waiting, have not been reported. The PIVOT used overall mortality as its primary endpoint.
A quality-of-life substudy was conducted in 326 of the men in the randomized study. Men filled out questionnaires at a median of about 4 years after study entry. The principal differences in symptoms between the two groups were in sexual and urinary function. (For more information on sexual and urinary function, refer to the Sexuality and Reproductive Issues summary.) In the surgery and watchful waiting groups, 80% versus 45% of the men answering the questionnaire said they seldom or never had erections sufficient for sexual intercourse. Forty-nine percent of men in the prostatectomy arm had urinary leakage at least once a week, 43% used protective aids regularly, and 14% used diapers or urine bags compared to 21%, 10%, and 1%, respectively, in the watchful waiting arm; however, the men on the watchful waiting arm had more obstructive symptoms (e.g., severe symptoms on the American Urologic Symptom Index of 7% in the watchful waiting arm vs. 10% in the prostatectomy arm and moderate symptoms of 42% vs. 24%).[Level of evidence: 1iiC]