XCancer

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

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).

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)

Government Study Link:

NCT07455903 - Click here to see study on

ClinicalTrials.gov

Flotufolastat

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
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)