THE PROSTATE-CANCER INTERVENTION VERSUS OBSERVATION TRIAL - A RANDOMIZED 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 controlled trial sponsored by the Department of Veterans A ffairs and the National Cancer Institute. PIVOT will enroll 2,000 part icipants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less th an 75 years old will be randomized to either radical prostatectomy wit h early intervention for disease persistence/recurrence or expectant m anagement with palliative therapy reserved for symptomatic or metastat ic disease progression. Participants will be excluded if they have rec eived prior therapy for prostate cancer (except transurethral resectio n of the prostate) or are judged not to be candidates for radical pros tatectomy. All patients with newly diagnosed prostate cancer will be r ecorded on the PIVOT screening log. Registry information will include patient age, race, prostate specific antigen level, clinical stage, hi stological tumor grade, initial therapy, and vital status. Patients me eting eligibility criteria will watch an information and randomization video tape developed for PIVOT. Participants will be randomized over a 3-year period and followed for a minimum of 12 years. Data collected at followup will include urological symptoms, disease and treatment r elated morbidity, and disease specific and overall quality of life. Ev idence of symptomatic or asymptomatic disease persistence, recurrence or progression will be measured by questionnaire, physical examination , digital rectal examination, prostate specific antigen and annual bon e scan. The primary study end point will be all cause mortality. Secon dary outcomes will include prostate cancer and treatment specific morb idity and mortality rates, health status, predictors of disease specif ic outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relati ve decrease in prostate cancer specific mortality rate by either treat ment strategy.