drugset / Trial / NCT03700099

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide

NCT03700099

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-09-03
Primary completion
2024-03-01
Completion
2025-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Enzalutamide Other / unclassified 160 mg Oral