Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1/2NCT06615752
Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
A Phase 1/2 study testing green tea and quercetin + docetaxel in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- green tea and quercetin + docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Feb 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059
Piwen Wang, PhD, 323-563-4999, piwenwang@cdrewu.edu
About this study
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
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.
- Being tested
- green tea and quercetin + docetaxel, Placebo + docetaxel
- Keywords
- green tea, quercetin, docetaxel, prostate cancer, phase II
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea and quercetin + docetaxelDrug
Also called GT and Q
green tea and quercetin supplements in combination with docetaxel infusion
Placebo + docetaxelDrug
Also called Placebo
Placebo will be given along with docetaxel chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| green tea and quercetin | Experimental | Green tea and quercetin capsules will be administered in combination with docetaxel treatment. Receives: Drug: green tea and quercetin + docetaxel |
| placebo | Placebo comparator | Placebo capsules will be administered in combination with docetaxel treatment as comparison. Receives: Drug: Placebo + docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 11 weeks
Secondary outcomes (6)
circulating tumor DNA level (ctDNA) analyzed by next generation sequencing
CtDNA will be measured at the 1st day of each cycle of docetaxel treatment, and at the end of the intervention.
Measured: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
tumor burden by CT detection
Tumor burden, including tumor number and size, will be assessed in both primary and metastatic sites using computed tomography (CT), to assist in the evaluation of complete response vs. stable disease vs. progressive disease using the RECIST criteria.
Measured: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Adverse events graded by using NCI CTCAE criteria
The Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, will be followed for a comprehensive evaluation of adverse events in multiple systems including blood, liver, gastrointestinal tract, and neural system.
Measured: 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
The AUC of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Measured: 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
The Cmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Measured: 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)
The Tmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Measured: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Watts Healthcare Corporation
- Responsible party
- Principal investigator, Piwen Wang, Charles Drew University of Medicine and Science
- Investigators
- Piwen Wang, PhD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615752
- Sponsor's protocol ID
- 2188250-3
- Other IDs
- 2U54MD007598-16
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06615752
- Acronym / sponsor ID
- 2188250-3
- Keywords
- green tea, quercetin, docetaxel, prostate cancer, phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Watts Healthcare Corporation
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| green tea and quercetin | Experimental | Drug: green tea and quercetin + docetaxelGreen tea and quercetin capsules will be administered in combination with docetaxel treatment. |
| placebo | Placebo comparator | Drug: Placebo + docetaxelPlacebo capsules will be administered in combination with docetaxel treatment as comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green tea and quercetin + docetaxelAlso: GT and Qgreen tea and quercetin supplements in combination with docetaxel infusion | Drug | green tea and quercetin |
| Placebo + docetaxelAlso: PlaceboPlacebo will be given along with docetaxel chemotherapy | Drug | placebo |
Primary outcome
Efficacy evaluated with blood prostate specific antigen (PSA) level
Time frame: From enrollment to the end of treatment at 11 weeks
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piwen Wang, PhD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing green tea and quercetin + docetaxel in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piwen Wang, PhD (3235634999, PiwenWang@cdrewu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluated with blood prostate specific antigen (PSA) level (time frame: From enrollment to the end of treatment at 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.