Recruiting
Phase 1
Phase 2

Docetaxel with Green Tea & Quercetin

Sponsor:

Charles Drew University of Medicine and Science

Code:

NCT06615752

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

green tea and quercetin + docetaxel

Placebo + docetaxel

Study Details

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study ID

NCT06615752

Start date

Oct, 2026

Status verified date

Apr, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: green tea and quercetin

Green tea and quercetin capsules will be administered in combination with docetaxel treatment.

placebo comparator: placebo

Placebo capsules will be administered in combination with docetaxel treatment as comparison.

Interventions

green tea and quercetin + docetaxel

green tea and quercetin supplements in combination with docetaxel infusion

Placebo + docetaxel

Placebo will be given along with docetaxel chemotherapy

Primary outcome measure

  • Efficacy evaluated with blood prostate specific antigen (PSA) level [ Time Frame: From enrollment to the end of treatment at 11 weeks ]

Central Contacts and Locations

Central contacts

Piwen Wang, PhD

3235634999PiwenWang@cdrewu.edu

Locations

Charles R. Drew University of Medicine and Science

Recruiting

Los Angeles, California, United States, 90059

Contacts

Piwen Wang, PhD

323-563-4999piwenwang@cdrewu.edu

More Information

Sponsor

Charles Drew University of Medicine and Science

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • green tea
  • quercetin
  • docetaxel
  • prostate cancer
  • phase II

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Charles Drew University of Medicine and Science on 2026-04-15.