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
Principal Investigator: Aaron Edward Katz.
Other Investigators: David Jaihun Byun, Victor Ricardo Adorno Febles, Peter B. Schiff, James R Lewis, Anthony Corcoran, Thomas B. Daniels, Minas Platon Economides, Jonathan W Lischalk, Scot Niglio, Todd J Carpenter, Jeffrey Todd Schiff, Jonathan Haas, Jagdeep Raince, Andrew J Evans, Michael J. Zelefsky, Hank Ng, David R. Wise.


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