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

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