Phase II Trial of Androgen Suppression and Radiation Therapy with Samarium-153 in Localized, High-Risk, Prostate Cancer

摘要

The purpose of this award was to develop the above trial along with its implementation. In addition, the funding supported the submission for a Clinical Trial Award proposal to the Department of Defense Granting Agency that was submitted, as required, in December, 2004. This involved the formation of a clinical protocol, informed consent, and data submission forms. Under the terms of the Clinical Trial Development Award, basic or clinical research was not permitted so I do not have any data to report. As stated in my SOW, we carried out an extensive medical literature review to determine appropriate patient population and sample size. The design and statistical methods for this multi- institutional phase II clinical trial were developed in collaboration with the Director of Biostatistics Shared Resource of the Kimmel Cancer Center (KCC) at Thomas Jefferson University, Dr. Walter Hauck. The primary objective of this multi-institutional phase II clinical trial was to document the ability of samarium-153, when given with neoadjuvant HT and RT, to inhibit the development of disease progression as compared to historical controls.