Randomized Controlled Trial of ProstAtak® 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