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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Docetaxel 75 mg/m2 IV every 3 weeks, for 6-10 cycles.
Upon disease progression after treatment with docetaxel, patients will receive Enzalutamide 160 mg P.O. daily until disease progression or limiting toxicity.
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil
Correlate AR-V7 status in circulating tumor cells (positive versus negative) and PSA response decline > 50% after therapy with docetaxel
Time frame: 6 months
Correlate AR-V7 status in circulating tumor cells (positive versus negative) and PSA decline > 50% after therapy with enzalutamide
Time frame: 12 months
Correlate AR mutations (present versus absent) and PSA response decline > 50% after therapy with docetaxel.
Time frame: 6 months
Correlate AR mutations (present versus absent) and PSA response decline > 50% after therapy with enzalutamide.
Time frame: 12 months
Correlate AR-V7 status in circulating tumor cells (positive versus negative) and time to PSA progression after docetaxel.
Time frame: 12 months
Correlate AR-V7 status in circulating tumor cells (positive versus negative) and time to PSA progression after enzalutamide.
Time frame: 12 months
Correlate AR mutations (present versus absent) and time to PSA progression after docetaxel.
Time frame: 12 months
Correlate AR mutations (present versus absent) and time to PSA progression after enzalutamide.
Time frame: 12 months
Correlate AR-V7 status in circulating tumor cells (positive versus negative) and overall survival.
Time frame: 24 months
Correlate AR mutations (present versus absent) and median overall survival.
Time frame: 24 months
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