Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

Inclusion Criteria include:

Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature

NCCN Intermediate Risk is defined as having at least one of the following: 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: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Planning to undergo standard prostate-only external beam radiation therapy
ECOG Performance Status 0-2

Exclusion Criteria include:

Liver disease, including known cirrhosis or active hepatitis
Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
Known HIV+ patients
Regional lymph node involvement or distant metastases
Patients planning to receive whole pelvic irradiation
Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
Patients who had or plan to have orchiectomy as the form of hormonal ablation
Known sensitivity or allergic reactions to acyclovir or valacyclovir