Background: The lack of evidence regarding the effectiveness of treatment options for clinically localised prostate cancer continues to impact on clinical decision-making. Two such options are radical prostatectomy (RP) and watchful waiting (WW). WW involves providing no initial treatment and monitoring the patient with the intention of providing palliative treatment if there is evidence of disease progression.
Objectives: To compare the beneficial and harmful effects of RP versus WW for the treatment of localised prostate cancer.
Search strategy: MEDLINE, EMBASE, The Cochrane Library, ISI Science Citation Index, DARE and LILACS were searched through 30 July 2010.
Selection criteria: Randomised or quasi-randomised controlled trials comparing the effects of RP versus WW for clinically localised prostate cancer.
Data collection and analysis: Data extraction and quality assessment were carried out independently by two authors.
Main results: Two trials met the inclusion criteria. Both trials commenced prior to the widespread availability of prostate-specific antigen (PSA) screening; hence the results may not be applicable to men with PSA-detected disease.One trial (N = 142), conducted in the US, was judged to be of poor quality. All cause (overall) mortality was not significantly different between RP and WW groups after fifteen years of follow up (Hazard Ratio (HR) 0.9 (95% Confidence Interval (CI) 0.56 to 1.43).The second trial (N = 695), conducted in Scandinavia, was judged to be of good quality. After 12 years of follow up, the trial results were compatible with a beneficial effect of RP on the risks of overall mortality, prostate cancer mortality and distant metastases compared with WW but the precise magnitude of the effect is uncertain as indicated by the width of the confidence intervals for all estimates (risk difference (RD) -7.1% (95% CI -14.7 to 0.5); RD -5.4% (95% CI -11.1 to 0.2); RD -6.7% (95% CI -13.2 to -0.2), respectively). Compared to WW, RP increased the absolute risks of erectile dysfunction (RD 35% (95% CI 25 to 45)) and urinary leakage (RD 27% (95% CI 17 to 37)). These estimates must be interpreted cautiously as they are derived from data obtained from a self-administered questionnaire survey of a sample of the trial participants (N = 326), no baseline quality of life data were obtained and nerve-sparing surgery was not routinely performed on trial participants undergoing RP.
Authors' conclusions: The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer. The results of ongoing trials should help to inform treatment decisions for men with screen-detected localised prostate cancer.