The treatment of early stage prostate cancer is shrouded with controversy, as it is well recognized that many men are overtreated for malignancy that might never become clinically significant. Although evidence from previous trials had indicated limited benefit for radical prostatectomy compared with observation, these studies were conducted in the era before prostate-specific antigen (PSA) testing became widespread. Now, a randomized trial with 12 years follow-up data has shown that men with localized disease who remain untreated derive the same benefit as those treated with radical prostatectomy, but avoid the harms associated with surgery.

Timothy Wilt and colleagues conducted a randomized trial in 731 men with localized prostate cancer, aged 75 years or younger, to compare radical prostatectomy with observation. Overall, all-cause mortality and prostate-cancer mortality were not significantly different among men treated with surgery versus observation. Subgroup analyses showed no benefit of treatment in men with a PSA ≤10 ng/ml or with low-risk disease. However, in men with high-risk disease or PSA values >10 ng/ml, surgery reduced all-cause and prostate-cancer mortality.

Wilt highlights the significance of these findings, “this type of treatment trial is extremely challenging to undertake, but our study is successful in demonstrating that observation is a wise approach in the vast majority of men who can avoid the harms related to treatment and experience a long and healthy life. Although the results are not entirely unexpected, they provide the evidence needed for health-care providers to help patients to make an informed choice.”