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NCT05053152 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
A Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT05053152 is a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 194 participants, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT05053152, a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Bone Scan
- OTHER Fluciclovine F18
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Marin General Hospital - Greenbrae
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Memorial Medical Center - Modesto
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Sutter Medical Center Sacramento - Sacramento
- Sutter Pacific Medical Foundation - Santa Rosa
- Sutter Solano Medical Center/Cancer Center - Vallejo
Colorado
- UCHealth University of Colorado Hospital - Aurora
- Rocky Mountain Cancer Centers-Boulder - Boulder
- UCHealth Memorial Hospital Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- AdventHealth Porter - Denver
- Shaw Cancer Center - Edwards
- Poudre Valley Hospital - Fort Collins
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05053152
The ClinicalTrials.gov registry entry for NCT05053152 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (11% lower). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05053152 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT05053152 about?
NCT05053152 is a clinical study titled "Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study". 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 medi...
What is the current status of trial NCT05053152?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2022-04-20. Estimated completion is 2029-02-01.
What conditions does trial NCT05053152 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Oligometastatic Prostate Carcinoma, Prostate Ductal Adenocarcinoma, Prostate Intraductal Carcinoma.
What interventions are being tested in trial NCT05053152?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Fluciclovine F18 (OTHER).
Who is sponsoring clinical trial NCT05053152?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05053152 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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