Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery

Exclusion Criteria

• •Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.
• •Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start.
• •Evidence of metastatic disease
• •Prostate volume \>50cc
• •Prior prostate surgery (hyperthermia, cryotherapy, etc.)
• •Prior pelvic radiotherapy
• •Prior androgen ablation hormonal therapy (except finasteride if discontinued \> 3 mo. prior to enrollment)
• •Patients on corticosteroids or any immunosuppressive drugs.
• •History of liver disease, such as cirrhosis or active/chronic hepatitis B or C.
• •History of or current alcohol misuse/abuse within the past 12 months.
• •Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector/Valacyclovir).
• •Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).
• •No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years.
• •Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.
• •Patients \< 18 years of age
• •Unwilling or unable to comply with the study protocol.