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

Prior treatment

• Patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs
• Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
• Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)

Other illness

• Active liver disease, including known cirrhosis or active hepatitis
• Known HIV+ patients
• 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
• Patients who had or plan to use ADT or have history of an orchiectomy.
• Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
• Known sensitivity or allergic reactions to acyclovir or valacyclovir

Other

• Regional lymph node involvement or distant metastases

• 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