THE PROSTATE-CANCER INTERVENTION VERSUS OBSERVATION TRIAL (PIVOT) - ARANDOMIZED TRIAL COMPARING RADICAL PROSTATECTOMY VERSUS EXPECTANT MANAGEMENT FOR THE TREATMENT OF CLINICALLY LOCALIZED PROSTATE-CANCER

The Prostate cancer Intervention Versus Observation Trial (PIVOT) is a randomized trial designed to determine whether early intervention wit h radical prostatectomy or expectant management should be the preferre d treatment for men with clinically localized prostate cancer. This tr ial will enroll 2000 participants younger than 75 years of age from 75 Department of Veterans Affairs and National Cancer Institute medical centers. Men will be excluded if they are judged not to be candidates for radical prostatectomy. Eligible participants will be randomized ov er a 3-year period and followed for a minimum of 12 years. Follow-up d ata will include urologic symptoms, disease- and treatment-related mor bidity, and disease-specific and overall quality of life. Evidence of disease persistence, recurrence, or progression will be measured by qu estionnaire, physical examination, prostate specific antigen measure, and bone scan. The primary study end point will be all-cause mortality . Secondary outcomes will include prostate cancer and treatment-specif ic morbidity and mortality, health status, predictors of disease-speci fic outcomes, and cost-effectiveness.