PHASE I-II STUDY ON HSV-TK GENE THERAPY + RADIOTHERAPY FOR PROSTATE CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with radiotherapy in previously untreated prostate cancer. This study is comprised of three arms (see below for subject population criteria). Arm A will include low risk patients (with favorable prognostic factors) while arm B will have high risk patients (with unfavorable prognostic factors). Arm C is comprised of patients with pathologic proven iliac lymph node metastasis (Stage D1). Arms B and C patients will receive neoadjuvant androgen ablation as part of their standard of care. Clinical response as evaluated by changes in serum PSA level and digital rectal examination as well as by histological alterations on re-biopsy such as the presence of apoptosis, necrosis, tumor proliferation and immunologic response, will be assessed following HSV-tk + valacyclovir treatment. Blood samples are also taken for assessment of systemic immunological response. Serum testosterone will be measured. Additionally, patients will be followed closely to assess nadir PSA, freedom from PSA-progression, and freedom from local and distant progression and overall survival.