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The management of patients with prostate-specific antigen (PSA)-screening-detected early-stage prostate cancer remains controversial. Now, investigators report results of a trial initiated in 1994 that compared outcomes associated with prostatectomy versus observation in 731 men (age, ≤75) with localized disease (stage T1–2, NX, M0) and PSA values <50 ng/mL.
Patients were randomized to radical prostatectomy or observation; the observation group was offered systemic therapy or other palliative treatment for symptomatic or metastatic progression. Patients were seen every 6 months for 8 to 15 years, and bone scans were obtained every 5 years. The original study was powered on the basis of 2000 patients, but slow accrual led to study amendment a…