Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)
NRG Oncology
194 participants
Apr 20, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Undergo urine and blood sample collection
Undergo bone scan
Undergo CT and/or PET/CT
Given fluciclovine F18
Undergo MRI and/or PET/MRI
Given PO
Undergo PET/CT and/or PET/MRI
Undergo PSMA PET/CT or PET/MRI
Given PO
Undergo SABR
Locations(239)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05053152