NCT07455903 · Baptist Health South Florida
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
What this study is about
The purpose of this research study is to test the effectiveness 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).
View original scientific description
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).
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
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.
Where
- Miami, Florida
Collaborators
Blue Earth Diagnostics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations