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, 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)
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