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Study of ADT with PSMA PET/CT for High-Risk Prostate Cancer

This study is looking at how well different hormone therapies (leuprolide, degarelix, relugolix, or triptorelin, sometimes with bicalutamide) work for men with high-risk prostate cancer that hasn't spread. These treatments are given before surgery to remove the prostate. Researchers will use a special scan called an 18F-Flotufolastat PSMA PET/CT to see if the treatments shrink the cancer. The study aims to see how much the cancer marker (PSMA) changes after treatment. You might be able to join if you are a man aged 18 or older with high-risk prostate cancer that can be removed by surgery. The study is currently unclear on its recruitment status.

Study design
This is a single-arm, open-label study involving 50 participants. It is designed to test the effectiveness of treatments without comparing them to a placebo or another treatment group.
What's involved
You would receive hormone therapy for about 6 months, followed by prostate removal surgery. After surgery, you will have blood tests and report any new or worsening symptoms for 48 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 48 months after your prostate removal surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07455903

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Baptist Health South Florida
~50 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:LeuprolideDegarelixRelugolixTriptorelinBicalutamide18-F Flotufolastat PSMA PET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) based on PSMA PET
Measured over 6 Months
+1 more outcome measured

Conditions

Prostate Cancer
Localized Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Rohan Garje, M.D.
[email protected]
786-596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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:

Exclusion

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
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.

What this trial measures

  • Objective response rate (ORR) based on PSMA PET6 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.

  • ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0)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.