A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec

Prior treatment

• Participants on systemic corticosteroids (\> 10 mg prednisone per day) or other immunosuppressive drugs
• Participants planning to receive whole pelvic irradiation
• Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator.

Other illness

• Active liver disease, including known cirrhosis or active hepatitis
• Known HIV+ participants
• 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. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease.
• Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

Other

• Regional lymph node involvement or distant metastases
• Participants who had or plan to have orchiectomy as the form of hormonal ablation

• Participants must give study-specific informed consent prior to enrollment
• Histologically confirmed adenocarcinoma of the prostate
• Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
• Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)
• 18 years of age or older
• Performance status must be Eastern Cooperative Oncology Group 0-2
• The following laboratory criteria must be met (treatment group only):
  • Aspartate aminotransferase (AST) \< 3 x upper limit of normal
  • Serum creatinine \< 2 mg/dL
  • Calculated creatinine clearance \> 30 mL/min
  • White blood cells \> 3000/mm3
  • Platelets \>100,000/mm3