Radical prostatectomy reduced death and progression more than watchful waiting in early prostate cancer.

M e t h o d s Design: Randomized controlled trial (Scandinavian Prostate Cancer Group Study Number 4). Allocation: {Concealed}†.* Blinding: Blinded {outcome assessors, data safety and monitoring committee, and data analysts}†.* Follow-up period: Mean 8.5 to 8.8 years (median 8.2 y). Setting: 14 centers in Sweden, Finland, and Iceland. Patients: 695 men < 75 years of age (mean age 65 y) with newly diagnosed, untreated, localized prostate cancer; tumor stage T0d (later changed to T1b), T1, or T2; life expectancy > 10 years; prostate-specific antigen (PSA) level < 50 ng/mL; and no abnormalities on bone scan. Intervention: RP (n = 347) or WW (n = 348). Outcomes: Death from prostate cancer, distant metastasis, local progression, and death from any cause. Patient follow-up: 100% (intention-to-treat analysis).