An Asia-wide Translational Research on High-risk Group Detection for Prostate Cancer

Purpose of Research， Research Contents， Collaborative Research Organization， Roadmap

In order to seek a complete and total cure for prostate cancer in Asia, where it is predicted to drastically increase
with the westernization of Asia life-style including diet, we will conduct the Asian ms-SNP analysis to identify
high risk groups and the translational research of IL-12 gene therapy as an international collaborative research.
Through this collaborative research, we will depict the Asia-wide genetic predisposition for prostate cancer by
ms-SNP data analyzed for disease risk and recurrence risk combined with conventional clinical risk factors and
standardize the clinical parameters for immune gene therapy. We will eventually seek better ways to carry out
various Asian translational studies in advanced clinical application fields including gene therapy.

First, we prospectively analyze Okayama University's ms-SNP data, i.e.cumulative association of several variants
with Japanese prostate cancer, in Korean, Chinese, and Singaporean populations. Through theses Asia-wide
analyses, we will elucidate genetic predisposition for prostate cancer among the East Asian, which, together with
conventional parameters, enables us to identify high risk groups.
Second, multi-institutional clinical studies on IL-12 immunogene therapy for prostate cancer will be carried out.
A phaseⅠ/Ⅱ study to assess the safety and maximum tolerated dose of adenoviral vector is being conducted
at Okayama University（As of Feb.2009）. A clinical protocol for the institutional review board at participating
institutions as well as for their government will be prepared based on the authorized protocol in Japan and carried
out using an optimum dose detected by Okayama University. These multi-institutional clinical studies will lead to
establish an international network for translational research.
Finally, Neoadjuvant IL-12 gene therapy, i.e.,gene therapy before radical prostatectomy to prevent cancer
recurrence, will be applied to the resulting "high risk group patients" in Asian countries. This will verify the
effectiveness on ms-SNP data application to the gene therapy and cancer prognosis. We will also standardize
the clinical parameters for immunogene therapy through this collaborative study.

With Professor Hiromi KUMON of the Graduate School of Medicine, Dentistry and Pharmaceutical Science of
Okayama University, Japan as its head, this collaborative research organization consists of leading academic
medical researchers of urology in each participating Asian country, thus enables to start a collaborative
translational research in advanced clinical application field with securing its safety. This research is based on the
mutually beneficial relationship by linking the accumulated assents and complementary roles of participating
institution. This is otherwise unable to be accomplished. Completing this collaborative research project will lead
us to establish the international science community for Asian translational research.

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