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Trial Title:
Green Tea and Quercetin in Combination with Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
NCT ID:
NCT06615752
Condition:
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Docetaxel
Quercetin
Conditions: Keywords:
green tea
quercetin
docetaxel
prostate cancer
phase II
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
green tea and quercetin + docetaxel
Description:
green tea and quercetin supplements in combination with docetaxel infusion
Arm group label:
green tea and quercetin
Other name:
GT and Q
Intervention type:
Drug
Intervention name:
Placebo + docetaxel
Description:
Placebo will be given along with docetaxel chemotherapy
Arm group label:
placebo
Other name:
Placebo
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Gender description:
only biologically male is eligible for this study
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Charles R. Drew University of Medicine and Science
Address:
City:
Los Angeles
Zip:
90059
Country:
United States
Start date:
November 2024
Completion date:
February 2029
Lead sponsor:
Agency:
Charles Drew University of Medicine and Science
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Collaborator:
Agency:
Watts Healthcare Corporation
Agency class:
Other
Source:
Charles Drew University of Medicine and Science
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06615752
