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
Mayo Clinic
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.
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 a…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 (obtaine…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo PET/CT
- OtherFlotufolastat F-18 Gallium
Given flotufolastat F 18
- ProcedureLaparoscopic Radical Prostatectomy with Robotics
Undergo robotic assisted radical prostatectomy
- ProcedurePelvic Lymphadenectomy
Undergo pelvic lymph node dissection
- ProcedurePositron Emission Tomography
Undergo PET/CT
- Drug
Location
- Mayo Clinic in ArizonaScottsdale, Arizona