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

August 4, 2026 updated by: Baptist Health South Florida

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

  • Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.

    1. cT3-cT4
    2. International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)
    3. PSA >20 ng/mL
  • Clinically negative lymph nodes as established by PSMA PET/CT imaging. Patients who are node positive by PSMA PET/CT (e.g., N1), but whose nodes do not meet traditional size criteria for positivity (e.g., they measure ≥ 10mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 and would be eligible for this study.
  • Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant person or individual of childbearing potential (until 1 week after completing 18F-flotufolastat PSMA PET/CT Scans.

  • Clinical laboratory values during screening:

    1. Hemoglobin ≥ 10.0 g/dL
    2. Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
    3. Platelets ≥ 100 × 10⁹/L

Exclusion Criteria:

  • 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
  • Renal impairment (glomerular filtration rate <30 mL/min)
  • History of prior radiation therapy for prostate cancer
  • Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant ventricular arrhythmias, or New York Heart Association Class II to IV heart disease.
  • Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection.

  • Other malignancies other than prostate cancer in the past 5 years

    a. Cured basal cell or squamous cell skin cancers can be enrolled.

  • Severe or uncontrolled concurrent infections are not eligible.
  • Treated with concomitant cytotoxic cancer therapy for any other primary site.
  • Patients who are unable to complete the study requirements of 2nd PSMA imaging or surgery for the primary endpoints.
  • Any condition that, in the opinion of the investigator, would preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Leuprolide
22.5 mg IM every 3 months × 2 doses
Other Names:
  • Lupron
  • Eligard
Drug: Degarelix
240 mg SC loading dose, then 80 mg SC q28 days × 6 months
Other Names:
  • Firmagon
Drug: Relugolix
360 mg PO Day 1, then 120 mg PO daily × 6 months
Other Names:
  • Orgovyx
Drug: Triptorelin
11.25 mg IM every 3 months × 2 doses
Other Names:
  • Trelstar
Drug: Bicalutamide
Given only with leuprolide or triptorelin; 50 mg PO daily for 30 days
Other Names:
  • Casodex
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.
Other Names:
  • Posluma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) based on PSMA PET
Time Frame: 6 Months
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.
6 Months
ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0)
Time Frame: 6 Months
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate-Specific Antigen (PSA) response rate
Time Frame: 36 Months
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.
36 Months
Biochemical recurrence-free survival (BCR) with testosterone recovery
Time Frame: 36 months
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).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

Blue Earth Diagnostics

Investigators

  • Principal Investigator: Rohan Garje, M.D., Miami Cancer Institute at Baptist Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-GAR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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