Context

Prostate cancer (PCA) remains a common and potentially fatal condition. Effective and safe treatment options are needed. However, few randomised trials have assessed the benefits and harms of radical prostatectomy (RPX), radiation therapy (XRT) and watchful waiting/observation to provide the evidence base for treating men with clinically localised PCA. The Scandinavian Prostate Cancer Group-4 (SPCG-4) trial randomised 695 men diagnosed in the pre-prostate-specific antigen (PSA) era, most had palpable disease, to surgery or observation.1 After a median follow-up of 13.4 years, surgery reduced PCA deaths by 44% (HR=0.56; 95% CI 0.41 to 0.77; absolute risk reduction=11 percentage points). All-cause mortality was reduced by 12.7 percentage points. Reductions were confined to men <65 years of age.

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) randomised 731 men from the early PSA era to RPX or observation.2 After a 10-year median follow-up, surgery did not reduce disease-specific mortality (HR=0.63; 95% CI 0.36 to 1.09). There was also no significant reduction for all-cause mortality. Absolute differences were <3 percentage points for PCA and all-cause mortality. However, there was some evidence suggesting a subgroup effect favouring surgery in men with a PSA >10 ng/mL or intermediate risk disease (p for interaction=0.11 for PCA mortality in both subgroups). The Prostate Testing …