The prostate cancer intervention versus observation trial (PIVOT). 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 trial designed to determine whether early intervention with radical prostatectomy or expectant management should be the preferred treatment for men with clinically localized prostate cancer. This trial 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 over a 3‐year period and followed for a minimum of 12 years. Follow‐up data will include urologic symptoms, disease‐ and treatment‐related morbidity, and disease‐specific and overall quality of life. Evidence of disease persistence, recurrence, or progression will be measured by questionnaire, 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‐specific morbidity and mortality, health status, predictors of disease‐specific outcomes, and cost‐effectiveness. Cancer 1995;75:1963–8.