Green tea and quercetin with docetaxel for metastatic castration-resistant prostate cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with metastatic castration-resistant prostate cancer who are starting docetaxel plus prednisone are assigned to receive either green tea with quercetin or a matched placebo alongside their chemotherapy. The study includes an initial phase to establish safety and dosing followed by a phase focused on whether the combination improves therapeutic outcomes compared with placebo. Investigators will monitor side effects, blood counts, liver tests, and measures of cancer response during treatment. Primary outcomes include tolerability and anti-tumor activity such as response rates and disease progression.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Piwen Wang, PhD — Charles Drew University of Medicine and Science
• Study coordinator: Piwen Wang, PhD
• Email: PiwenWang@cdrewu.edu
• Phone: 3235634999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• REGN15505 Alone or With Cemiplimab or REGN4336 in Advanced Prostate Cancer and Kidney Cancer

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• Oral INR731 alone or with androgen receptor blockers for metastatic castration-resistant prostate cancer

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• Lu‑177 PSMA‑3D1015 injections for men with metastatic castration‑resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.