NCT07025369 · Mayo Clinic
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
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Computed Tomography
Undergo PET/CT
OTHER
Flotufolastat F-18 Gallium
Given flotufolastat F 18
PROCEDURE
Laparoscopic Radical Prostatectomy with Robotics
Undergo robotic assisted radical prostatectomy
PROCEDURE
Pelvic Lymphadenectomy
Undergo pelvic lymph node dissection
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
DRUG
Relugolix
Given PO
Primary outcome measures
Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET)
Time frame: 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 PET
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Scottsdale, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations