Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
This is a phase II multi-center study to determine the clinical impact of using a
patient-specific genomic expression signature of androgen receptor (AR) activity to determine
therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After
patient eligibility is determined, the genomic signature will be applied to fresh frozen
tissue harvested from a metastatic lesion during image-guided biopsy. After assessing for
androgen receptor activity, the investigators will select patients for either continued
androgen manipulation with nilutamide (high AR activity) or targeted therapy with dasatinib
(low AR activity). Once patients develop a first progression on either arm, patients will
receive combination therapy with dasatinib and nilutamide. The primary aim is to estimate the
median progression free survival in men with CRPC treated according to tumor AR activity. The
investigators hypothesize that by treating men based upon AR activity, median progression
free survival (PFS) will improve from a historical median of 3.0 months to 6.0 months.