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
Phase 2 Randomized Study to Assess Use of Androgen Deprivation to Enrich PSMA Expression and Improve Sensitivity of Staging PSMA PET/CT: The EnrichPSMA Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan."
- "In addition, patients undergo collection of blood samples throughout the study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a short course of relugolix, a drug that lowers testosterone, helps PSMA PET/CT scans find more prostate cancer. It may raise levels of PSMA, a protein on prostate cancer cells that the scan targets. The study is for adults with high-risk or very high-risk prostate cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and have prostate adenocarcinoma confirmed by a tissue test.
- Have high-risk or very high-risk cancer: grade group 4 or 5, PSA blood level above 20, or stage cT3 cancer seen on MRI.
- Have a testosterone level of at least 300.
- Be able to care for yourself and be out of bed or a chair for at least half of your waking hours (ECOG score 0–2).
- Have blood tests within 120 days before study entry showing hemoglobin of at least 9.0 g/dL, neutrophils of at least 1,500/mm³, and platelets of at least 100,000/mm³. These measure oxygen-carrying protein, infection-fighting cells, and cells that help blood clot.
- Use condoms during sex and do not donate semen during treatment and for 30 days after the last dose.
- If your female partner can become pregnant, have a documented vasectomy, avoid sex, or use effective birth control with your partner during treatment and for 30 days after the last dose.
- Sign a form agreeing to take part after learning about the study.
Who can't join
- Have had chemotherapy within 2 weeks before study entry, any prior hormone-lowering treatment for prostate cancer, or radiation to the pelvis.
- Have another serious illness that the study doctor believes would make the study unsafe or make its effects hard to assess.
- Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat.
- Have a mental health condition or social situation that would make it hard to follow study requirements.
- Are receiving another experimental drug to treat the prostate cancer.
- Have had another active cancer within the past year, except skin cancer that is not melanoma. If you had cancer before, you must not still be receiving treatment for it.
- Have had a heart attack within 6 months, or have heart failure requiring ongoing treatment for life-threatening abnormal heartbeats.
- Take medicines called P-glycoprotein inhibitors, which affect how some drugs move through the body.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
AZ
- Mayo Clinic in Arizona · Scottsdale, AZ 85259Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduJack R. Andrews, MD · Principal investigatorMore trials in Scottsdale