RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06615752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. * Male patients 18 years or older
  4. * Diagnosed with metastatic prostate cancer
  5. * History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration
  6. * Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
  7. * Clinical decision to start doc infusion with prednisone treatment
  8. * Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³)
  9. * 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)
  10. * Adequate renal function (serum creatinine level within normal limits)
  11. * At least a 6-month or greater life expectancy
  12. * 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
  1. * Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
  2. * Any comorbid condition that would preclude the administration of docetaxel/prednisone
  3. * Ongoing alcohol abuse
  4. * Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
  5. * Prior allergic reaction to tea, tea products or quercetin supplements
  6. * Allergies to multiple food items or nutritional supplements

Contacts and Locations

Study Contact

Piwen Wang, PhD
CONTACT
3235634999
PiwenWang@cdrewu.edu

Principal Investigator

Piwen Wang, PhD
PRINCIPAL_INVESTIGATOR
Charles Drew University of Medicine and Science

Study Locations (Sites)

Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059
United States

Collaborators and Investigators

Sponsor: Charles Drew University of Medicine and Science

  • Piwen Wang, PhD, PRINCIPAL_INVESTIGATOR, Charles Drew University of Medicine and Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2029-02

Study Record Updates

Study Start Date2025-07
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)