[Gene therapy for castration resistant prostate cancer]

Prostate is an ideal target organ for the gene therapy as a translational research (TR). It has advantages as follows: prostate is not a life keeping organ, can be approached easily by ultrasound as a routine clinical technique and PSA is a potent tumor marked for the evaluation of clinical response. Many clinical gene therapy trials for castration resistant prostate cancer (CRPC) have been conducted in many institutes showing clinical safety and efficacy including Japanese trial. A phase I/II study of adenovirus-mediated REIC/Dkk-3 gene therapy for CRPC was initiated in Okayama university hospital and oncolytic Herpes virus therapy was also ongoing in Tokyo university hospital. In spite of limited cases, some clinically positive results are observed. In this paper ongoing development of gene therapy for CRPC is reported and legal issues which are essential for the management of clinical gene therapy are also explained.