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

Charles Drew University of Medicine and Science

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Treatments: Drug: Placebo + docetaxel; Drug: green tea and quercetin + docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06615752

U54MD007598-16 (U.S. NIH Grant/Contract)

2188250-3

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

green tea and quercetin

Experimental group

Description:

Green tea and quercetin capsules will be administered in combination with docetaxel treatment.

Treatment:

Drug: green tea and quercetin + docetaxel

placebo

Placebo Comparator group

Description:

Placebo capsules will be administered in combination with docetaxel treatment as comparison.

Treatment:

Drug: Placebo + docetaxel