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Relugolix and Imaging for High-Risk Prostate Cancer (The EnrichPSMA Trial)

This study, called The EnrichPSMA Trial, is looking at how a short course of relugolix, a medication that lowers male hormones (androgen deprivation therapy or ADT), can improve imaging for prostate cancer. Specifically, it's investigating if relugolix helps a special type of scan called PSMA PET/CT (positron emission tomography/computed tomography) better detect prostate cancer, especially in lymph nodes. PSMA PET/CT is a common imaging tool for high-risk prostate cancer, but it can sometimes miss cancer in lymph nodes. The study aims to see if relugolix can increase the amount of PSMA protein on cancer cells, making them easier to see on the scan. You may be eligible if you are an adult male with high-risk or very high-risk prostate adenocarcinoma. The main goal is to compare how well the PSMA PET/CT scan works before and after taking relugolix.

Study design
This is an interventional study with a planned enrollment of 30 participants. Participants will be assigned to one of three groups to receive different durations of relugolix.
What's involved
You would undergo blood draws, PSMA PET/CT scans, and take relugolix daily for 5 or 10 days. Some participants will also have robotic radical prostatectomy and pelvic lymph node dissection.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured up to day 15 after starting the study, but some procedures like surgery may occur within 90 days of the second PET/CT scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~30 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyFlotufolastat F-18 GalliumLaparoscopic Radical Prostatectomy with RoboticsPelvic LymphadenectomyPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET)
Measured over Day 0 up to day 15
+1 more outcome measured

Conditions

Prostate Adenocarcinoma
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8

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Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Jack R. Andrews, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 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. \[Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI\]
Testosterone greater than or equal to 300
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
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)
Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:
Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix)
Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix)
Those with female partners of childbearing potential may be enrolled if they are:
Documented to be surgically sterile (i.e., vasectomy);
Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or
Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix)
Provide written informed consent

Exclusion

Any of the following prior therapies:
Chemotherapy ≤ 2 weeks prior to registration/randomization
Androgen deprivation therapy
Pelvic radiation
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy ≤ 1 year prior to registration
EXCEPTIONS: Non-melanotic skin cancer
NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Use of P-glycoprotein inhibitors

What this trial measures

  • Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET)Day 0 up to day 15

    Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups.

  • Mean standard uptake value (SUVmean) for pre and post ADT PSMA PETDay 0 up to day 15

    Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups