Green Tea, Quercetin + Chemotherapy for Prostate Cancer

Overseen By Piwen Wang, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Charles Drew University of Medicine and Science

Must be taking: Docetaxel, Prednisone

Disqualifiers: Chemotherapy, Radiotherapy, Alcohol abuse, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Piwen Wang, PhD

Principal Investigator

Charles Drew University of Medicine and Science

Eligibility Criteria

This trial is for men with advanced prostate cancer that continues to grow despite hormone therapy. Participants must have metastatic castration-resistant prostate cancer and be suitable for docetaxel chemotherapy. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.

Inclusion Criteria

My cancer has worsened despite treatment with specific prostate cancer medications.

I have been diagnosed with prostate cancer that has spread.

I am willing and able to follow the study rules and attend all required visits.

Exclusion Criteria

Ongoing alcohol abuse

Significant medical or psychiatric conditions that would make the patient a poor protocol candidate

I have received chemotherapy or radiotherapy for cancer that has spread.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive green tea and quercetin in combination with docetaxel chemotherapy or placebo for 3 cycles, each cycle lasting 21 days

9 weeks

3 visits (in-person) at the start of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Docetaxel
• Green Tea and Quercetin

Trial Overview The study tests if green tea and quercetin can boost the effectiveness of docetaxel chemotherapy in treating advanced prostate cancer. Patients will either receive a placebo or the natural product combination alongside their standard chemotherapy regimen.

Participant Groups

Group I: green tea and quercetin Experimental Treatment 1 Intervention

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

Group II: placebo Placebo Group 1 Intervention

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

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Charles Drew University of Medicine and Science

Lead Sponsor

Trials

54

Recruited

8,500+

Watts Healthcare Corporation

Collaborator

Trials

1

Recruited

100+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+