Actively Recruiting
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Led by Baptist Health South Florida · Updated on 2026-05-13
50
Participants Needed
1
Research Sites
231 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
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
Official 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 prior to participation
- Male aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed prostate adenocarcinoma eligible for radical prostatectomy
- At least one high-risk feature based on NCCN guidelines: cT3-cT4, ISUP Grade group 4 or 5 (Gleason score 8-10), or PSA over 20 ng/mL
- Clinically negative lymph nodes by PSMA PET/CT, including nodes positive by PSMA PET/CT but smaller than 10mm by imaging
- Willing to use barrier contraception plus another effective contraceptive method if sexually active with a pregnant person or individual of childbearing potential until one week after 18F-flotufolastat PSMA PET/CT scans
- Laboratory values during screening: hemoglobin 10.0 g/dL or higher, absolute neutrophil count 1.8 x 10^9/L or higher, platelets 100 x 10^9/L or higher
You will not qualify if you...
- Allergies, hypersensitivity, 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 the bifurcation of the common iliac arteries on PSMA PET/CT
- Renal impairment with glomerular filtration rate below 30 mL/min
- History of prior radiation therapy for prostate cancer
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, significant ventricular arrhythmias, or NYHA Class II-IV heart disease within 6 months before treatment
- Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection
- Other malignancies except cured basal or squamous cell skin cancers within 5 years
- Severe or uncontrolled infections
- Concurrent cytotoxic cancer therapy for other primary cancer
- Inability to complete required PSMA imaging or surgery
- Any condition that investigator believes would prevent study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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