关键词：临床试验;激素;前列腺癌;疾病;基因;肿瘤;患者
摘 要：Our efforts over this reporting period (April 1, 2011 to March 31, 2012) were on proposing one new concept , finishing development of another concept and accruing to six DOD-PCCTC trials including two that stem from major contributions by our group. c11-089 is a randomized, gene fusion-stratified Phase II trial investigating Abiraterone ABT-888 in mCRPC. The hypothesis of the trial is that therapeutic targeting based on ETS gene fusions can improve disease response rates in patients with these molecular subtypes of cancer and in patients with ETS fusionpositive tumors, the targeting of the promoter and the transcription factor of the ETS fusion is more effective than targeting a single aspect of the fusion. The TMPRSS2-ETS gene fusion (discovered by a UM researcher) is present in over 50of all prostate cancers (ERG is the most common fusion partner of the ETS genes with TMPRSS2). The biomarker-stratified design will be used to determine if there is a response difference between treatments by ETS gene fusion-positive and fusion-negative strata. UM will be the lead site for this trial with the Univ. of Chicago N01 Phase II consortium as the coordinating center. Ten comprehensive cancer centers (six of which are DOD-PCCTC member sites) will be participating in this trial, with interest from other outside institutions as well as possibly an additional PCCTC member site. This trial was selected to be part of the Stand Up to Cancer (SU2C) Prostate Cancer Dream Team Translational Cancer Research Grant (AACR/PCF) This trial was activated at our site by the NCI on 4/18/2012. c11-080 is a multi-institutional Phase I and biomarker study of Everolimus combined with hormonal and radiation therapy for high risk prostate cancer introduced to the PCCTC by Dr. Daniel Hamstra who is the PI 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.