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RECRUITING Phase 2

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

NCT05053152 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 194 participants
Start Date 2022-04-20
Est. Completion 2029-02-01
Phase Phase 2

Sponsor

NRG Oncology

162 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05053152 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05053152?

This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial