Actively Recruiting
Phase 2 Randomized Study to Assess Androgen Deprivation with Relugolix to Improve PSMA PET/CT Imaging Sensitivity in High Risk Prostate Cancer The EnrichPSMA Trial
Led by Mayo Clinic · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a short course of androgen deprivation therapy (ADT) with relugolix affects the expression of prostate-specific membrane antigen (PSMA) and the quality of diagnostic imaging using PSMA PET/CT in patients with high or very high risk prostate cancer. PSMA PET/CT is commonly used to detect prostate cancer, but it has limitations in identifying cancer spread to lymph nodes. Relugolix works by reducing testosterone production, which may increase PSMA expression on tumor cells, potentially improving detection of smaller cancer areas. Participants are assigned to one of three groups receiving different durations of relugolix: 5, 10, or 15 days. Each patient undergoes a PSMA PET/CT scan with flotufolastat F 18 before starting relugolix and another scan after completing their assigned treatment duration. Following these scans, patients have robotic radical prostatectomy with pelvic lymph node dissection within 90 days. Blood samples are collected throughout the study to monitor effects and safety. During the trial, patients have multiple PET/CT scans and blood tests to assess changes in PSMA expression and lymph node involvement. Researchers measure uptake values of the radioactive tracer in tumors before and after ADT to evaluate imaging improvements. They also monitor for any adverse events up to 90 days after the second scan. The study's total duration includes treatment, imaging, surgery, and follow-up assessments to understand the impact of relugolix on prostate cancer imaging.
CONDITIONS
Brief 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 18 years or older
- Male with histological confirmation of prostate adenocarcinoma
- High risk or very high risk prostate cancer per NCCN criteria (grade group 4 or 5, PSA over 20, or radiographic cT3 on MRI)
- Testosterone level 300 or higher
- ECOG performance status 0, 1, or 2
- Hemoglobin 9.0 g/dL or higher (within 120 days before enrollment)
- Absolute neutrophil count 1500/mm^3 or higher (within 120 days before enrollment)
- Platelet count 100,000/mm^3 or higher (within 120 days before enrollment)
- Commitment to use contraception or abstinence 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 enrollment
- Previous androgen deprivation therapy
- Prior pelvic radiation
- Severe co-morbid illnesses or conditions interfering with safety or assessment
- Uncontrolled infection, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Use of other investigational treatments for prostate cancer
- Other active cancers within 1 year except non-melanotic skin cancer
- History of recent myocardial infarction (within 6 months) or life-threatening heart arrhythmias
- Use of P-glycoprotein inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 to 15 days
Participants receive relugolix orally once daily for 5, 10, or 15 days depending on their assigned group. They undergo PET/CT scans with flotufolastat F 18 before treatment and after completing relugolix.
2 PET/CT visits (in-person) and daily oral medication for up to 15 days
Duration - Up to 90 days
Participants undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days after the second PET/CT scan.
1 surgical procedure and follow-up visits within 90 days
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
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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