drugset / Trial / NCT05053152

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

NCT05053152

Phase 2 Active not recruiting 194 enrolled NRG Oncology National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Timeline

Start
2022-04-20
Primary completion
2029-02-01
Completion
2029-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Relugolix Small molecule Oral