The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
Signed informed consent must be obtained prior to participation in the study.
Males aged ≥18 years.
ECOG performance status ≤ 1
Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
Unable to receive androgen deprivation therapy.
Prostate cancer with significant neuroendocrine or other rare variant pathology
Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
Single group
Leuprolide
Drug22.5 mg IM every 3 months × 2 doses
Degarelix
Drug240 mg SC loading dose, then 80 mg SC q28 days × 6 months
Relugolix
Drug360 mg PO Day 1, then 120 mg PO daily × 6 months
Triptorelin
Drug11.25 mg IM every 3 months × 2 doses
Bicalutamide
DrugGiven only with leuprolide or triptorelin; 50 mg PO daily for 30 days
18-F Flotufolastat PSMA PET
Diagnostic test296 MBq (8mCi) administered as an intravenous bolus injection prior to PSMA PET scan. May be administered diluted in normal saline (NS) or undiluted. The maximum volume of undiluted 18F-flotufolastat is 5mL. After administration, a flush with 0.9% NS will be given to ensure full delivery of the dose.
Radical prostatectomy
Procedure/SurgerySurgery to occur 14 to 90 days after the pre-surgery visit. All RPs will be performed per institutional standard of care by fellowship-trained urologic oncologists, with an extended pelvic lymph-node dissection when clinically indicated.
Objective response rate (ORR) based on PSMA PET
ORR is based on changes in maximum standard uptake value (SUVmax) on PSMA PET/CT imaging pre- and post-ADT. Complete response (CR) is defined as resolution of all PSMA-avid lesions. Partial response (PR) is defined as \>30% decrease in SUVmax. Progressive disease (PD) is defined as \>30% increase in SUVmax or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on SUVmax.
ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0)
ORR in this endpoint is based on RECIP 1.0 criteria. Complete response (CR) is defined as disappearance of all PSMA-avid disease. Partial response (PR) is defined as ≥30% increase in total tumor volume. Progressive disease (PD) is defined as ≥20% increase in total tumor volume or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on RECIP 1.0.
Prostate-Specific Antigen (PSA) response rate
Defined as the proportion of participants with a PSA reduction of at least 50% (PSA50) immediately prior to RP compared with baseline PSA after treatment with ADT.
Biochemical recurrence-free survival (BCR) with testosterone recovery
BCR with testosterone recovery is defined as the time from ADT initiation to PSA ≥0.2 ng/mL after RP once testosterone has normalized. Median times will be calculated for responders (CR and PR) and non-responders (SD and PD).
Click on the lead sponsor to view all of their trials.
Baptist Health South Florida
Lead sponsor
Blue Earth Diagnostics
Collaborator
