Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
Conditions
Metastatic Castration-resistant Prostate Cancer (mCRPC)Drugs
green tea and quercetin + docetaxel, Placebo + docetaxelSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Piwen Wang, PhD
- 323-563-4999
- [email protected]
Principal Investigator
- Piwen Wang, PhD
Eligibility Criteria
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 abiraterone acetate
* Clinical decision to start doc infusion with prednisone treatment
* Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³)
* Adequate liver function (total bilirubin less than upper limit of normal (ULN), alanine aminotransferase (ALT) less than 1.5 x ULN, aspartate aminotransferase (AST) less than 1.5 x ULN)
* Adequate renal function (serum creatinine level within normal limits)
* At least a 6-month or greater life expectancy
* Willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Exclusion Criteria:
* Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
* Any comorbid condition that would preclude the administration of docetaxel/prednisone
* Ongoing alcohol abuse
* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* Prior allergic reaction to tea, tea products or quercetin supplements
* Allergies to multiple food items or nutritional supplements
Study Plan
green tea and quercetin
EXPERIMENTAL
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
DRUG:
green tea and quercetin + docetaxelDescription:
green tea and quercetin supplements in combination with docetaxel infusion
placebo
PLACEBO_COMPARATOR
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
DRUG:
Placebo + docetaxelDescription:
Placebo will be given along with docetaxel chemotherapy
Outcome Measures
Primary Outcome Measures
Efficacy evaluated with blood prostate specific antigen (PSA) level
Secondary Outcome Measures
circulating tumor DNA level (ctDNA) analyzed by next generation sequencing
tumor burden by CT detection
Adverse events graded by using NCI CTCAE criteria
Area under curve (AUC) of blood green tea, quercetin, and docetaxel
Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel
Time taken to reach the maximum concentration (Tmax)
Timeline
Last Updated
July 16, 2025Start Date
September 27, 2024Today
October 17, 2025Completion Date ( Estimated )
February 1, 2029
Sponsors of this trial
Lead Sponsor
Charles Drew University of Medicine and ScienceCollaborating Sponsors
National Institute on Minority Health and Health Disparities (NIMHD), Watts Healthcare Corporation