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Clinical Trial Summary

This is a prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel and enzalutamide. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study. The primary goal of this study is to evaluate the association of the AR-V7 status and androgen receptor (AR) gene alterations with PSA response to docetaxel and enzalutamide.


Clinical Trial Description

This study is a prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel followed by enzalutamide. In this study, all participants will receive standard of care treatment with docetaxel 75 mg/m2 every 3 weeks up to 10 cycles and after progression, patients will receive enzalutamide 160 mg daily until limiting toxicity or disease progression. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03700099
Study type Interventional
Source Instituto do Cancer do Estado de São Paulo
Contact Ingrid Barbosa
Phone +55 11 3893-3535
Email ingrid.barbosa@hc.fm.usp.br
Status Not yet recruiting
Phase Phase 2
Start date December 2018
Completion date December 2021

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