Clinical Research Directory

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. 1. cT3-cT4 2. International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10) 3. 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: 1. Hemoglobin ≥ 10.0 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L 3. 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.