The @entity263 Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized XXXX .

@entity1 @entity263 @entity5 @entity10094 @entity1486
The @entity263 Intervention Versus Observation Trial (PIVOT) is a randomized controlled trial sponsored by the Department of Veterans Affairs and the National @entity5 Institute. PIVOT will enroll 2,000 @entity1 from at least 80 Veterans Administration and National @entity5 Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized @entity263 (stage T1/T2NXM0) of all histological grades. @entity1 less than 75 years old will be randomized to either radical prostatectomy with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. @entity1 will be excluded if they have received prior therapy for @entity263 (except transurethral resection of the prostate) or are judged not to be candidates for radical prostectomy. All @entity1 with newly diagnosed @entity263 will be recorded on the PIVOT screening log. Registry information will include @entity1 age, race, @entity1486 level, clinical stage, histological @entity5 grade, initial therapy, and vital status. @entity1 meeting eligibility criteria will watch an information and randomization video tape developed for PIVOT. @entity1 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 related morbidity, and disease specific and overall quality of life. Evidence of symptomatic or @entity10094 persistence, recurrence or progression will be measured by questionnaire, physical examination, digital rectal examination, @entity1486 and annual bone scan. The primary study end point will be all cause mortality. Secondary outcomes will include @entity263 and treatment specific morbidity and mortality rates, health status, predictors of disease specific outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in @entity263 specific mortality rate by either treatment strategy.
