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

NCT06615752 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2188250-32U54MD007598-16
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Keywords

green tea; quercetin; docetaxel; prostate cancer; phase II

Outcome Measures

Primary Outcomes (1)

• Efficacy evaluated with blood prostate specific antigen (PSA) level

  Blood PSA will be measured at baseline, 1st day of each cycle of docetaxel treatment (21 days per cycle, for 3 cycles), and at the end of the intervention.

  From enrollment to the end of treatment at 11 weeks

Secondary Outcomes (6)

• circulating tumor DNA level (ctDNA) analyzed by next generation sequencing

  From the start of intervention at 3 weeks to the end of treatment at 11 weeks.

• tumor burden by CT detection

  From the start of intervention at 3 weeks to the end of treatment at 11 weeks.

• Adverse events graded by using NCI CTCAE criteria

  From the start of intervention at 3 weeks to the end of treatment at 11 weeks.

• Area under curve (AUC) of blood green tea, quercetin, and docetaxel

  On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.

• Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel

  On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.

Study Arms (2)

green tea and quercetin

EXPERIMENTAL

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

Drug: green tea and quercetin + docetaxel

placebo

PLACEBO COMPARATOR

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

Drug: Placebo + docetaxel

Interventions

green tea and quercetin + docetaxel DRUG

green tea and quercetin supplements in combination with docetaxel infusion

Also known as: GT and Q

green tea and quercetin

Placebo + docetaxel DRUG

Placebo will be given along with docetaxel chemotherapy

Also known as: Placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only biologically male is eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Watts Healthcare Corporation: collaborator

Study Sites (1)

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tea; Quercetin; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Piwen Wang, PhD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piwen Wang, PhD

CONTACT

3235634999; PiwenWang@cdrewu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study includes a dose-escalation study and an expanded phase II study. For the dose-escalation study, patients will be assigned to different dose levels in the order of recruiting. For the expanded phase II study, patients will be randomly assigned to the green tea plus quercetin group receiving green tea + quercetin + docetaxel, or the placebo group receiving placebo + docetaxel.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 27, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)