Observation or Radical Treatment in Patients With Prostate Cancer

OBJECTIVES: Primary * To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical, histological, or clinical progression criteria. Secondary * To compare overall survival, quality of life using the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory, distant disease-free survival, PSA relapse/progression after radical intervention, and initiation of androgen deprivation therapy between the two treatment arms. * To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer. * To determine if PSA doubling-time prior to diagnosis predicts eventual outcome. * To determine if molecular biomarkers predict outcome. OUTLINE: This is a prospective, randomized, multicenter study. Patients are stratified by treatment center, ECOG performance status (0 vs 1 or 2), disease stage (T1 vs T2), baseline PSA value (ng/mL or μg/L) (\< 5.0 vs ≥ 5.0 and ≤ 10.0), and age (\< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 arms. * Arm I: Patients undergo radical intervention (radical prostatectomy or radiotherapy \[external-beam radiotherapy 5 days a week for 4-8 weeks; permanent prostate brachytherapy; or high-dose rate temporary brachytherapy\], based on patient and physician preference). * Arm II: Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria (biochemical progression, histologic/grade progression, and/or clinical progression) are met. Quality of life is assessed by the EPIC-26, RAND SF-12, and State Anxiety Inventory at baseline, periodically during study treatment, and after completion of radical treatment. After completion of radical treatment, patients are followed every 6 months.