MedTrace Logo

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

NCT07455903 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Blue Earth Diagnostics

    collaborator INDUSTRY

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Rohan Garje, M.D. · Miami Cancer Institute at Baptist Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2029-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455903 on ClinicalTrials.gov