Actively Recruiting
Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)
Led by Baptist Health South Florida · Updated on 2026-05-13
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of neoadjuvant androgen deprivation therapy (ADT) on prostate-specific membrane antigen (PSMA) levels in patients with localized high-risk prostate cancer (LHRPC). This phase II, open-label study aims to measure changes in PSMA uptake using 18F-Flotufolastat PET/CT scans before and after ADT treatment. The study also investigates whether these changes can predict biochemical recurrence-free survival after surgery. Participants will receive one of four ADT treatments: leuprolide or triptorelin injections every three months for six months, degarelix injections every 28 days for six months, or daily oral relugolix for six months. Those receiving leuprolide or triptorelin will also take daily bicalutamide for 30 days. All participants will have PET scans at the start and after six months of ADT, followed by radical prostatectomy within 14 to 90 days after the last scan. During the study, participants will undergo blood tests and symptom tracking for up to 48 months after prostate removal as part of standard care. Researchers will assess treatment response through PET scan measurements and monitor prostate-specific antigen (PSA) levels and biochemical recurrence-free survival over 36 months. Safety monitoring and follow-up visits are included throughout the study timeline.
CONDITIONS
Brief Title
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before participation
- Male aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed prostate adenocarcinoma eligible for radical prostatectomy
- Pathologically proven prostate adenocarcinoma with at least one high-risk feature (cT3-cT4 stage, ISUP Grade group 4 or 5, or PSA >20 ng/mL)
- Clinically negative lymph nodes per PSMA PET/CT imaging criteria
- Willingness to use barrier contraception and another effective contraceptive method if sexually active with a person of childbearing potential until one week after the last PET/CT scan
- Screening laboratory values: hemoglobin ≥ 10.0 g/dL, absolute neutrophil count ≥ 1.8 × 10⁹/L, platelets ≥ 100 × 10⁹/L
You will not qualify if you...
- Known allergy or intolerance to 18F-flotufolastat
- Unable to receive androgen deprivation therapy
- Prostate cancer with significant neuroendocrine or rare variant pathology
- Evidence of metastatic disease involving bone, viscera, or lymph nodes above iliac artery bifurcation on PSMA PET/CT
- Renal impairment with glomerular filtration rate below 30 mL/min
- Prior radiation therapy for prostate cancer
- Severe or unstable cardiac conditions or heart disease within 6 months before treatment
- Uncontrolled severe hypertension, diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection
- Other malignancies except cured basal or squamous cell skin cancer within past 5 years
- Severe or uncontrolled infections
- Receiving cytotoxic cancer therapy for other primary cancers
- Unable to complete required imaging or surgery
- Any condition that would prevent study participation as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive neoadjuvant androgen deprivation therapy (ADT) using one of four drugs over approximately 6 months. Participants receiving leuprolide or triptorelin also take bicalutamide daily for 30 days. Participants undergo 18F-flotufolastat PSMA PET/CT scans at the start and end of treatment to evaluate therapy efficacy.
Monthly visits for injections or medication monitoring; 2 PET/CT scan visits (baseline and after 6 months of treatment)
Duration - Approximately 3 months
Participants undergo radical prostatectomy 14 to 90 days after completing ADT and the second PET/CT scan. Surgery is performed by specialized urologic oncologists following standard care protocols.
1 surgical visit and approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Rohan Garje, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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