Clinical Trials Logo

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 [email protected]
Status Recruiting
Phase Phase 2
Start date September 3, 2019
Completion date December 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04081636 - Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications N/A
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Recruiting NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Active, not recruiting NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Active, not recruiting NCT00499421 - Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy
Recruiting NCT03668652 - Focal Prostate Ablation Versus Radical Prostatectomy N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Recruiting NCT04060589 - ReIMAGINE Prostate Cancer Risk
Recruiting NCT04249154 - Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer Phase 2
Recruiting NCT04219059 - MR Radiomic Features in Prostate Cancer
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT00953576 - Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer Phase 1/Phase 2
Recruiting NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1