Clinical Trial · NCT07455903

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

Overview

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).

Sponsor

Baptist Health South Florida

Phase

Phase 2

Contacts

Rohan Garje, M.D. (CONTACT)

rohan.garje@baptisthealth.net

786-596-2000

Rohan Garje, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07455903

Drug / Compound

Flotufolastat

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.
Hemoglobin ≥ 10.0 g/dL
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.
Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
cT3-cT4
Platelets ≥ 100 × 10⁹/L
PSA \>20 ng/mL

Exclusion

Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
Prostate cancer with significant neuroendocrine or other rare variant pathology
Renal impairment (glomerular filtration rate \<30 mL/min)