In this review the best available evidence comparing the effects of two treatment options for localised prostate cancer, namely radical prostatectomy (RP) which involves surgically removing the prostate gland versus a "watchful waiting" (WW) approach was examined. In this review, WW is defined as any conservative approach to the management of prostate cancer whereby a decision is made to provide no initial treatment and to monitor the patient. If the monitoring procedure provides evidence of disease progression, then palliative treatment is offered to the patient, which is intended to alleviate disease symptoms without attempting to cure the disease.
Two completed randomised controlled trials were identified. One trial was considered to be of good quality whilst the second trial was of poor quality. The two trials commenced prior to the widespread use of the prostate-specific antigen (PSA) blood test as a screening test for prostate cancer, and hence did not involve many men with PSA-detected cancers. Ongoing trials (PIVOT; ProtecT; START) will provide evidence of the comparative effects of RP and observation protocols for men with PSA-detected cancers.
The one good quality trial included in this review involved men with cancers detected by methods other than screening who were randomly allocated to either RP or WW and followed up for 12 years. This single trial does not provide sufficient evidence to allow confident statements to be made about the magnitude of any beneficial and harmful effects of RP compared with WW for men with clinically detected prostate cancers. The trial results indicate that RP is likely to reduce the risks of overall mortality, prostate-cancer mortality and distant metastases (cancer spread) compared to WW, but the magnitude of the effect is unclear. Furthermore, the risk reductions appear to have been limited to men less than 65 years of age. This trial also provides evidence that RP increases the risks of erectile dysfunction and urinary leakage. However, because of the manner in which the data on adverse effects were collected in the trial, confident statements cannot be made about how frequently these adverse effects occur. In addition, nerve-sparing surgery, which has the potential to reduce these complications, was not routinely performed on participants in the trial.
A shared approach to decision-making is required whereby patients and their healthcare providers openly discuss the patient's personal values, preferences, and the limitations of the available evidence on potential benefits and potential harms of these treatment options.