A Phase I/II Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients
Charles Drew University of Medicine and Science
Summary
The goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of advanced prostate cancer, i.e., metastatic castration-resistant prostate cancer (mCRPC). It will also learn about the safety of this combination. Researchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male patients 18 years or older * Diagnosed with metastatic prostate cancer * History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration * Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abirateron…
Interventions
- Druggreen tea and quercetin + docetaxel
green tea and quercetin supplements in combination with docetaxel infusion
- DrugPlacebo + docetaxel
Placebo will be given along with docetaxel chemotherapy
Location
- Charles R. Drew University of Medicine and ScienceLos Angeles, California