Actively Recruiting
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
Led by Mayo Clinic · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years
- Histological confirmation of prostate adenocarcinoma
- Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification (grade group 4 or 5, PSA > 20, or radiographic cT3 on MRI)
- Testosterone greater than or equal to 300
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Hemoglobin 63; 9.0 g/dL (obtained 64; 120 days before registration/randomization)
- Absolute neutrophil count (ANC) 63; 1500/mm3 (obtained 64; 120 days before registration/randomization)
- Platelet count 63; 100,000/mm3 (obtained 64; 120 days before registration/randomization)
- Male patients committed to using condoms during treatment and for 30 days after last dose of relugolix
- Male patients who do not donate semen during treatment and for 30 days after last dose of relugolix
- Male patients with female partners of childbearing potential must be surgically sterile, practice abstinence, or use effective contraception during treatment and for 30 days after last dose of relugolix
- Provide written informed consent
You will not qualify if you...
- Prior chemotherapy within 2 weeks before registration/randomization
- Prior androgen deprivation therapy
- Prior pelvic radiation
- Severe concurrent diseases or systemic illnesses that could interfere with safety or assessment
- Uncontrolled illness including active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents for primary cancer treatment
- Any other active cancer within 1 year prior to registration except non-melanotic skin cancer
- History of myocardial infarction within 6 months or congestive heart failure requiring ongoing maintenance therapy
- Use of P-glycoprotein inhibitors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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