Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by David S. Hong (uci)

Description

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.

Official Title

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Details

Keywords

Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Ductal Adenocarcinoma, Prostate Intraductal Carcinoma, Stage IVB Prostate Cancer AJCC v8, Carcinoma, Prostatic Neoplasms, Adenocarcinoma, Carcinoma, Intraductal, Noninfiltrating, Relugolix, Biospecimen Collection, Bone Scan, Computed Tomography, Fluciclovine F18, Magnetic Resonance Imaging, Positron Emission Tomography, PSMA PET Scan, Stereotactic Body Radiation Therapy, relugolix, SABR

Eligibility

Locations

Lead Scientist at University of California Health

  • David S. Hong (uci)
    Assistant Health Sciences Professor, Radiation Oncology, School of Medicine. Authored (or co-authored) 10 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT05053152
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 194 study participants
Last Updated