Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

Inclusion Criteria include: * Histologically confirmed adenocarcinoma of the prostate * Patients choosing active surveillance * Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature * NCCN Low Risk is defined as having all of the following: PSA \< 10 ng/ml, Gleason ≤ 6, T1-T2a * NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c * High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a * Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1 * Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections. * ECOG Performance status 0-2 Exclusion Criteria include: * Active liver disease, including known cirrhosis or active hepatitis * Patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs * Known HIV+ patients * Regional lymph node involvement or distant metastases * Other current malignancy (except squamous or basal cell skin cancers) * Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up * Prior treatment for prostate cancer except TURP. If prior TURP, patient…