Trials / Active Not Recruiting
Active Not RecruitingNCT03700099
Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide
Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Sequential Treatment With Docetaxel and Enzalutamide
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Instituto do Cancer do Estado de São Paulo · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | Docetaxel 75 mg/m2 IV every 3 weeks, for 6-10 cycles. |
| DRUG | Enzalutamide | Upon disease progression after treatment with docetaxel, patients will receive Enzalutamide 160 mg P.O. daily until disease progression or limiting toxicity. |
Timeline
- Start date
- 2019-09-03
- Primary completion
- 2024-03-01
- Completion
- 2025-04-01
- First posted
- 2018-10-09
- Last updated
- 2024-04-15
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03700099. Inclusion in this directory is not an endorsement.