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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether green tea and quercetin help docetaxel chemotherapy work better and whether the combination is safe. It is for men with prostate cancer that has spread and keeps growing despite treatment to lower or block male hormones. Everyone will receive docetaxel, with either green tea and quercetin or a placebo (a look-alike with no drug).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older with prostate cancer that has spread to other parts of the body.
  • Cancer has worsened despite medicines or surgery to lower male hormones.
  • Cancer has also worsened while taking enzalutamide, apalutamide, darolutamide, or abiraterone acetate.
  • Your care team has decided to start docetaxel through a vein, along with prednisone.
  • Blood tests show enough infection-fighting cells and platelets (cells that help stop bleeding), and liver and kidney function meet study limits.
  • Expected to live at least 6 months.
  • Willing to sign consent and health privacy forms, follow study steps, and be available for the full study.
  • Willing to stop all tea, tea-containing products, and quercetin supplements during treatment, except those provided by the study.

Who can't join

  • You have had chemotherapy or radiation treatment for cancer that has spread.
  • You have another health condition that prevents treatment with docetaxel and prednisone.
  • You have ongoing alcohol abuse.
  • You have a serious medical or mental health condition that makes the study unsuitable for you.
  • You have had an allergic reaction to tea, tea products, or quercetin supplements.
  • You are allergic to several foods or nutrition supplements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

CA