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

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT07455903
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)
    Participants will be prescribed one of four ADTs, administered over two treatment cycles spaced three months apart. * Leuprolide: Administered by a Health Care Practitioner (HCP), injecting the drug into the muscle every 3 months for 6 months total. * Degarelix: Administered by a HCP, injecting the drug under your skin every 28 days for 6 months. * Relugolix: Self-administered orally (pill), once daily for 6 months. * Triptorelin: Administered by a HCP, injecting the drug into the muscle every 3 months for 6 months total. Note: For those who receive leuprolide or triptorelin, bicalutamide also will be prescribed to take daily for 30 days starting from Day 1 of receiving leuprolide or triptorelin. All participants will receive a PET using 18F-flotufolastat at baseline and after 6 months of treatment with ADT. All participants will receive radical prostatectomy after the second 18F-flotufolastat PET scan.

Primary Outcome Measure

Objective response rate (ORR) based on PSMA PET [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Rohan Garje, MD
[email protected]
786-596-2000

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

Related Studies