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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: Recruiting Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by NRG Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The rPFS curves will be estimated by the Kaplan-Meier method and compared between the two treatment arms using a one-sided, logrank test stratified by the three randomization factors.
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 |
What NCT05053152 shows while recruiting
NCT05053152 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (11% lower).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05053152's enrollment target sits among peer trials
194 23rd of 99 higher than 77 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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