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

NCT07455903 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-GAR-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Localized Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  6 Months

• 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.

  6 Months

Secondary Outcomes (2)

• Prostate-Specific Antigen (PSA) response rate

  36 Months

• Biochemical recurrence-free survival (BCR) with testosterone recovery

  36 months

Study Arms (1)

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

EXPERIMENTAL

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; Drug: Degarelix; Drug: Relugolix; Drug: Triptorelin; Drug: Bicalutamide; Diagnostic Test: 18-F Flotufolastat PSMA PET; Procedure: Radical prostatectomy

Interventions

Leuprolide DRUG

22.5 mg IM every 3 months × 2 doses

Also known as: Lupron, Eligard

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

Degarelix DRUG

240 mg SC loading dose, then 80 mg SC q28 days × 6 months

Also known as: Firmagon

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

Relugolix DRUG

360 mg PO Day 1, then 120 mg PO daily × 6 months

Also known as: Orgovyx

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

Triptorelin DRUG

11.25 mg IM every 3 months × 2 doses

Also known as: Trelstar

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

Bicalutamide DRUG

Given only with leuprolide or triptorelin; 50 mg PO daily for 30 days

Also known as: Casodex

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

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.

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

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.

Also known as: Posluma

Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• cT3-cT4
• International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)
• 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:
• Hemoglobin ≥ 10.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
• Platelets ≥ 100 × 10⁹/L

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Related Links

• Miami Cancer Institute

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; luprolide acetate gel depot; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; relugolix; Triptorelin Pamoate; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Rohan Garje, M.D.

  Miami Cancer Institute at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohan Garje, M.D.

CONTACT

786-596-2000; rohan.garje@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)