INTREPId (INTermediate Risk Erection PreservatIon Trial): A Randomized Trial of Radiation Therapy and Darolutamide for Prostate Cancer
Brief description of study
This is a randomized non-inferiority trial of 6-months of gonadotropin releasing hormone (GnRH) agonist and bicalutamide plus radiation therapy (RT) versus 6-months of Darolutamide plus RT for intermediate risk prostate cancer. Participants will be stratified by Decipher classification (low/intermediate vs high risk), RT modality (EBRT vs Brachytherapy/SBRT/combination RT), and age (>65 vs <65). The goal of this trial is to determine whether men who receive Darolutamide with RT are better able to preserve erectile function without sacrificing the potential for long-term disease control.
Clinical Study Identifier: s20-01236
ClinicalTrials.gov Identifier: NCT04025372
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