Phase III Study of Mildly Hypo-fractionated Image Guided Proton Beam Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Morbidity Outcomes
To determine if androgen suppression along with high dose proton radiation therapy will result in a higher freedom from failure (FFF) than high dose proton radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression
after the initial 100 patients have had a median follow up of at least three years and then every year.
No
Carlos Vargas, MD
Principal Investigator
Proton Collaborative Group
United States: Institutional Review Board
GU003-10
NCT01492972
January 2012
December 2021
Name | Location |
---|---|
ProCure Proton Therapy Center | Warrenville, Illinois 60555 |
ProCure Proton Therapy Center | Oklahoma City, Oklahoma 73142 |