Clinical Research Directory

Inclusion Criteria: * • Able to understand and sign informed consent form (ICF); * Males aged ≥ 18 years; * Histologically confirmed adenocarcinoma of the prostate; * Participants with high-risk prostate cancer according to either of the following: a) High-risk disease - at least one of the following: i. T3a ii. Gleason 8 or less iii. PSA ≤ 30 ng/mL iv. Gleason 9 (4+5) not more than 30% of the biopsy (e.g. a 10-needle biopsy can only have a maximum of 3 x 9 \[4+5\]); * PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC); * PSMA-PET within 90 days prior to randomization: negative for nodal or distant disease. * Candidate for definitive radiation to prostate and pelvis; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of ≥70%; * Testosterone ≥150 ng/dL or 5 nmol/L; * Adequate hematologic, renal, liver function (Hemoglobin ≥10 g/dL, Absolute Neutrophil Count ≥1.5x10⁹/L, Platelets ≥100x10⁹/L); * Judged to be medically fit for ADT and RT; * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment. Exclusion Criteria: * • Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors \[ARIs\]); * PSMA-PET positive nodal or distant metastases; * PTEN loss or equivocal by IHC (at least more than 50%); * Evidence of nodal or distant metastases on conventional imaging; * Prior pelvic radiation or prostate surgery interfering with RT (except biopsy/TURP); * Life expectancy \<5 years regardless of the prostate cancer; * Severe concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment (e.g. cardiovascular disease, hypertension, diabetes, etc); * Uncontrolled cardiovascular disease including: * Myocardial infarction within 6 months; * Unstable angina; * Congestive Heart Failure: New York Heart Association (NYHA) class III or IV; * Severe arrhythmia; * Active severe infection or immunocompromised; * Active second malignancy within 5 years with the exception of: * Non-melanoma skin cancer; * Chronic Lymphocytic Leukemia (CLL) that is stable and not actively treated; * Any condition compromising adherence to the protocol.