Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients

April 13, 2026 updated by: Piwen Wang, Charles Drew University of Medicine and Science

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90059
        • Recruiting
        • Charles R. Drew University of Medicine and Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: green tea and quercetin
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
Drug: green tea and quercetin + docetaxel
green tea and quercetin supplements in combination with docetaxel infusion
Other Names:
  • GT and Q
Placebo Comparator: placebo
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
Drug: Placebo + docetaxel
Placebo will be given along with docetaxel chemotherapy
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluated with blood prostate specific antigen (PSA) level
Time Frame: From enrollment to the end of treatment at 11 weeks
Blood PSA will be measured at baseline, 1st day of each cycle of docetaxel treatment (21 days per cycle, for 3 cycles), and at the end of the intervention.
From enrollment to the end of treatment at 11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
circulating tumor DNA level (ctDNA) analyzed by next generation sequencing
Time Frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
CtDNA will be measured at the 1st day of each cycle of docetaxel treatment, and at the end of the intervention.
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
tumor burden by CT detection
Time Frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Tumor burden, including tumor number and size, will be assessed in both primary and metastatic sites using computed tomography (CT), to assist in the evaluation of complete response vs. stable disease vs. progressive disease using the RECIST criteria.
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Adverse events graded by using NCI CTCAE criteria
Time Frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
The Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, will be followed for a comprehensive evaluation of adverse events in multiple systems including blood, liver, gastrointestinal tract, and neural system.
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Area under curve (AUC) of blood green tea, quercetin, and docetaxel
Time Frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
The AUC of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel
Time Frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
The Cmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Time taken to reach the maximum concentration (Tmax)
Time Frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
The Tmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Drew University of Medicine and Science

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Watts Healthcare Corporation

Investigators

  • Principal Investigator: Piwen Wang, PhD, Charles Drew University of Medicine and Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2188250-3
  • 2U54MD007598-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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