OncoMatch/Clinical Trials/NCT05053152
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
Is NCT05053152 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Relugolix for oligometastatic prostate carcinoma.
Treatment: Relugolix — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: KLK3 any tested (PSA <= 10.0 ng/mL and meets recurrence definitions)
Serum total prostate-specific antigen (PSA) <= 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions
Required: AR wild-type
Currently on androgen deprivation or anti-androgen therapy [excluded]
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — curative-intent to prostate (external beam and/or brachytherapy, or radical prostatectomy with/without post-op RT)
Prior curative-intent treatment to the prostate, by either: External beam and/or brachytherapy ... or radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy
Cannot have received: androgen deprivation therapy
Exception: prior ADT allowed if discontinued and testosterone >= 100 ng/dL
Currently on androgen deprivation or anti-androgen therapy [excluded]
Cannot have received: chemotherapy
Exception: prior chemotherapy for a different cancer is allowed if disease-free >= 3 years
Prior chemotherapy for prostate cancer or bilateral orchiectomy [excluded]
Cannot have received: bilateral orchiectomy
Prior chemotherapy for prostate cancer or bilateral orchiectomy [excluded]
Cannot have received: high dose radiotherapy to a lesion
Exception: lesions included in or near a previously irradiated PTV are eligible if previous delivered dose < EQD2 of 50 Gy
Prior high dose radiotherapy to a lesion (i.e. oligometastatic recurrence by PET) [excluded]
Lab requirements
Liver function
Total bilirubin <= 1.5 x ULN (Gilbert's syndrome: direct bilirubin <= 1.5 x ULN); AST and ALT <= 2.5 x ULN
Total bilirubin: <= 1.5 x ULN ... AST and ALT: <= 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cancer Center at Saint Joseph's · Phoenix, Arizona
- Alta Bates Summit Medical Center-Herrick Campus · Berkeley, California
- Tower Cancer Research Foundation · Beverly Hills, California
- Marin General Hospital · Greenbrae, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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