NCT07455903

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a single-arm, phase II, open label study in patients with localized high- risk prostate cancer (LHRPC) treated with neoadjuvant ADT (leuprolide, degarelix, relugolix, or triptorelin) followed by radical prostatectomy (RP). This study aims to evaluate the efficacy of neoadjuvant ADT based on maximal standardized uptake value (SUVmax) changes on 18F-Flotufolastat prostate- specific membrane antigen (PSMA) PET/CT scan in patients with LHRPC. Additionally, it will investigate the prognostic value of SUVmax changes in predicting biochemical recurrence-free survival.

Conditions

• Prostate Cancer
• Localized Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	Leuprolide	22.5 mg IM every 3 months × 2 doses
DRUG	Degarelix	240 mg SC loading dose, then 80 mg SC q28 days × 6 months
DRUG	Relugolix	360 mg PO Day 1, then 120 mg PO daily × 6 months
DRUG	Triptorelin	11.25 mg IM every 3 months × 2 doses
DRUG	Bicalutamide	Given only with leuprolide or triptorelin; 50 mg PO daily for 30 days
DIAGNOSTIC_TEST	18-F Flotufolastat PSMA PET	296 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.
PROCEDURE	Radical prostatectomy	Surgery 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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-10-01
• Completion: 2030-10-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study