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

NCT05053152 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-05-04

No results posted yet for this 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

  • Oligometastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Prostate Ductal Adenocarcinoma
  • Prostate Intraductal Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

OTHER

Fluciclovine F18

Given fluciclovine F18

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI and/or PET/MRI

DRUG

Placebo Administration

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT and/or PET/MRI

PROCEDURE

PSMA PET Scan

Undergo PSMA PET/CT or PET/MRI

DRUG

Relugolix

Given PO

RADIATION

Stereotactic Body Radiation Therapy

Undergo SABR

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Bridget F Koontz · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2029-02-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053152 on ClinicalTrials.gov