Abstract
TPS241 Background: Although androgen deprivation (ADT) is highly effective treatment for prostate cancer, eventual progression to a castrate-resistant state (CRPC) occurs in most patients (pts). CRPC has been characterized by increased androgen receptor (AR) expression, alterations in AR regulation, and other AR related mechanisms (Scher, JCO, 2005). Preclinical studies have shown that PC cell lines and tumor xenografts adapted to ADT are inhibited by re-administration of androgen, recapitulating the known growth inhibitory effects of testosterone on fetal prostate development (Chuu, Can Res, 2005; Joly-Pharaboz, J Ster Biochem Mol Bio, 2000). Phase I studies of testosterone replacement in men with asymptomatic CRPC have demonstrated the safety of this approach and suggest that disease stabilization may be observed in a subset of pts (Morris, Euro Uro, 2009; Szmulewitz, Euro Uro, 2009). Methods: The current study is a 1:1 randomized double-blind study of daily 1% testosterone gel (10g) versus matched plac...
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