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NCT07025369 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Prostate Adenocarcinoma and Stage IV Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07025369 is a Phase 2 study of Prostate Adenocarcinoma and Stage IV Prostate Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 30 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07025369, a Phase 2 study of Prostate Adenocarcinoma and Stage IV Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Flotufolastat F-18 Gallium
- PROCEDURE Laparoscopic Radical Prostatectomy with Robotics
- PROCEDURE Pelvic Lymphadenectomy
Study Locations (1)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07025369
The ClinicalTrials.gov registry entry for NCT07025369 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07025369 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT07025369 about?
NCT07025369 is a clinical study titled "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". 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...
What is the current status of trial NCT07025369?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-08-25. Estimated completion is 2026-12-31.
What conditions does trial NCT07025369 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT07025369?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Flotufolastat F-18 Gallium (OTHER), Laparoscopic Radical Prostatectomy with Robotics (PROCEDURE), Pelvic Lymphadenectomy (PROCEDURE).
Who is sponsoring clinical trial NCT07025369?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07025369 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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