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

Phase

1/2

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

green tea and quercetin + docetaxel

Placebo + docetaxel

Clinical Study ID

NCT06615752

2188250-3

U54MD007598-16

2U54MD007598-16

Ages > 18
Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Signed and dated informed consent form and HIPPA (Health Insurance Portability andAccountability Act) authorization.
Stated willingness to comply with all study procedures and availability for theduration 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 than1500cells/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 supplementsthroughout the entire intervention period except for the green tea extract andquercetin provided during study intervention

Exclusion

Exclusion Criteria:

Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
Any comorbid condition that would preclude the administration ofdocetaxel/prednisone
Ongoing alcohol abuse
Significant medical or psychiatric conditions that would make the patient a poorprotocol candidate
Prior allergic reaction to tea, tea products or quercetin supplements
Allergies to multiple food items or nutritional supplements

Study Design