Trials / Recruiting
RecruitingNCT07025369
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVE: I. Comparison of maximum standard uptake value (SUVmax) and SUVmean values of the dominate primary prostate lesion between pre and post androgen deprivation therapy (ADT) imaging using flotufolastat F-18 gallium (POSLUMA \[flotufolastat F 18\]) PET/CT. SECONDARY OBJECTIVES: I. Evaluate and compare the lymph node sensitivity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT. II. Comparison of lymph node prostate-specific membrane antigen (PSMA) avidity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT. OUTLINE: Patients are randomized to 1 of 3 arms. ARM A: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix orally (PO) once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 5. 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. ARM B: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 10. 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. ARM C: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-15 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 15. 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.
Conditions
- Prostate Adenocarcinoma
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-08-25
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2025-06-17
- Last updated
- 2026-03-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07025369. Inclusion in this directory is not an endorsement.