OncoMatch/Clinical Trials/NCT07025369
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial
Is NCT07025369 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Relugolix for prostate adenocarcinoma.
Treatment: Relugolix — This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IIC, III, IV (AJCC v8)
Grade: grade group 4grade group 5
Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. [Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: ≤ 2 weeks prior to registration/randomization
Chemotherapy ≤ 2 weeks prior to registration/randomization
Cannot have received: androgen deprivation therapy
Androgen deprivation therapy
Cannot have received: radiation therapy
Exception: pelvic
Pelvic radiation
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3 (all obtained ≤ 120 days prior to registration/randomization)
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 120 days prior to registration/randomization); Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 120 days prior to registration/randomization); Platelet count ≥ 100,000/mm^3 (obtained ≤ 120 days prior to registration/randomization)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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