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Prostate Cancer Clinical Trials Group: The University of Michigan Site

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Annual rept. 1 Apr 2010-31 Mar 2011

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Our efforts over this reporting period April 1, 2010 to March 31, 2011 was on proposing three new concepts and accruing to six DOD-PCCTC trials including two that stem from major contributions by our group c09-057 is a randomized, double-blind, placebo-controlled, multi-center Phase II trial investigating two EMD 525797 dosing regimens in asymptomatic or mildly symptomatic mCRPC subjects. Dr. Husain was heavily involved in the design of this study with the sponsor. Our site expects the protocol to be activated on May 10, 2011. c11-080 is a multi-institutional Phase I and biomarker study of Everolimus added to combined hormonal and radiation therapy for high risk prostate cancer introduced to the PCCTC by Dr. Daniel Hamstra who wrote the protocol for this study which was based on pre-clinical work supported by a Young Investigator Award from the Prostate Cancer Foundation PCF. The clinical trial is being supported by an ASCO Career Development Award. Three other PCCTC institutions will be participating in this study. We expect to activate this trial in late May or early June 2011. c11-079 is the Phase II expansion cohort of the randomized discontinuation trial of XL184 in solid tumors introduced to the PCCTC by Dr. David Smith. Dr. Smith and Dr. Hussain were involved in designing the expansion phase of this study with the sponsor. Nine other PCCTC institutions are participating in this trial. We also were the lead site for the c09-031 study which was a proof of principle pilot study looking at the combination of ABT-888 an oral PARP inhibitor with Temzolomide an oral DNA methylating agent in patients progressing on up to two prior therapies for castration-resistant disease. Dr. Hussain was involved in the trial design of this study with the sponsors. This trial completed accrual in October 2010. Six of the twentyfour patients accrued to this study were from our site.

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  • Medicine and Medical Research

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