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NCT Number: NCT06615752

Green Tea and Quercetin in Combination With Docetaxel Chemotherapy 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.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location status: Recruiting

Location contact

Piwen Wang, PhD

CONTACT

[email protected]

323-563-4999

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

green tea and quercetin + docetaxel

Drug

green tea and quercetin supplements in combination with docetaxel infusion

Other names: GT and Q

Placebo + docetaxel

Drug

Placebo will be given along with docetaxel chemotherapy

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Piwen Wang, PhD

CONTACT

[email protected]

3235634999

Sponsors and collaborators

Lead sponsor

Charles Drew University of Medicine and Science

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 27, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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