Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

Inclusion Criteria

• •1. Histologically confirmed adenocarcinoma of the prostate.
• •2. Age ≥ 18 years.
• •3. Clinically localized prostate cancer:
• •* T1 (Cancer can only be seen under a microscope),
• •* NX (Regional lymph nodes cannot be assessed) or N0 (Cancer cannot be seen in the lymph nodes),
• •* MX (Presence of distant metastasis cannot be assessed) or M0 (Cancer hasn't spread to other parts of the body).
• •4. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
• •5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• •6. Patients must have the following laboratory values:
• •1. Absolute neutrophil count (ANC) \> 1500/µL
• •2. Platelet count \>100,000/µL
• •3. Hemoglobin \> 10 g/dL
• •4. Bilirubin \< 1.5 x upper limits of normal
• •5. Aspartate aminotransferase (AST) \< 1.5 x upper limits of normal
• •6. Adequate estimated glomerular filtration rate (eGFR) \> 30 mL/min per 1.73 m2 (adjusted for race)
• •7. Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
• •8. Patient is accessible and compliant for follow-up.
• •9. Prostate biopsy requirements:
• •1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
• •2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit. Patients must have been diagnosed with prostate cancer within 2 years of randomization (no history of prostate adenocarcinoma in any biopsies taken more than 2 years prior to randomization).
• •10. Must have NCCN low or favorable-intermediate risk prostate cancer defined as:
• •* \<50% of cores involved with cancer for eligibility and 50% or greater of cores involved with cancer progression. Only cores from standard TRUS biopsy (not MRI-guided cores) will be counted towards the number of cores involved.
• •* No primary Gleason pattern 4 (Gleason score 4+3) disease in any cores (TRUS or MRI-guided)
• •* PSA less than 20 ng/mL
• •* No extracapsular extension (\<T3)
• •11. Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include:
• •1. surgical sterilization (patient and/or patient's partner),
• •2. approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot),
• •3. barrier methods (such as a condom or diaphragm) used with a spermicide, and
• •4. an intrauterine device (IUD).