Green tea and quercetin with docetaxel for metastatic castration-resistant prostate cancer.
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
PHASE1; PHASE2 · Charles Drew University of Medicine and Science · NCT06615752
This will test whether adding green tea and quercetin to docetaxel chemotherapy helps men with metastatic castration-resistant prostate cancer more than docetaxel with a placebo.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Charles Drew University of Medicine and Science (other) |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06615752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 or older with metastatic castration-resistant prostate cancer who are about to start docetaxel (and have adequate bone marrow and liver function and are on medical or surgical castration) are ideal candidates.
Not a fit: Patients who are not starting docetaxel, who have poor bone marrow or liver function, or who have non-metastatic disease are unlikely to benefit from this combination approach.
Why it matters
Potential benefit: If successful, adding green tea and quercetin could increase the effectiveness of docetaxel, potentially improving response or slowing disease progression.
How similar studies have performed: Preclinical studies and limited early clinical work suggest green tea compounds and quercetin have anti-cancer activity, but clinical evidence that adding them to chemotherapy improves outcomes in advanced prostate cancer is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Castration-resistant Prostate Cancer, green tea, quercetin, docetaxel, prostate cancer, phase II