Menu
Recruiting NCT06615752

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

Phase I / Phase II Interventional Metastatic Castration-resistant Prostate Cancer (mCRPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: green tea and quercetin + docetaxel, Placebo + docetaxel.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug green tea and quercetin + docetaxel
    green tea and quercetin supplements in combination with docetaxel infusion
  • Drug Placebo + docetaxel
    Placebo will be given along with docetaxel chemotherapy

Primary outcome measures

  • Efficacy evaluated with blood prostate specific antigen (PSA) level [Time frame: From enrollment to the end of treatment at 11 weeks]
Secondary outcome measures (6)
  • circulating tumor DNA level (ctDNA) analyzed by next generation sequencing [Time frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.]
  • tumor burden by CT detection [Time frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.]
  • Adverse events graded by using NCI CTCAE criteria [Time frame: 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 [Time frame: 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 [Time frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.]
  • Time taken to reach the maximum concentration (Tmax) [Time frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Charles R. Drew University of Medicine and Science — Los Angeles

Identifiers

NCT: NCT06615752 · 2188250-3 · 2U54MD007598-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗