[Adenovirus-mediated interleukin-12 gene therapy for prostate cancer]

As a human prostate cancer gene therapy trial, we have performed Herpes Simplex Virus-thymidine kinase gene transduction and ganciclovir therapy in locally advanced prostate cancer after radiation therapy(USA) or endocrine therapy(Japan). Safety and clinical efficacy were confirmed. In our current studies, we demonstrated the efficacy and safety of gene therapy approaches using recombinant adenoviral vector that transduce interleukin-12 in an orthotopic mouse model of prostate cancer. These preclinical studies will soon be resulted in the initiation of clinical trials using this approach(USA: FDA approved, Japan: Under IRB review) in advanced prostate cancer patients with or without metastasis after endocrine therapy. In this chapter, preclinical data and clinical protocol are introduced.