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

ConditionMetastatic Castration-resistant Prostate Cancer (mCRPC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCharles Drew University of Medicine and Science

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • green tea and quercetin + docetaxel

    Drug

    green tea and quercetin supplements in combination with docetaxel infusion

  • Placebo + docetaxel

    Drug

    Placebo will be given along with docetaxel chemotherapy

Treatment groups

99 Participants
are divided into 2 treatment groups
Group A: green tea and quercetinExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 11 weeks

Secondary outcomes

1

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.

Time frame
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
2

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.

Time frame
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
3

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.

Time frame
From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
4

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.

Time frame
On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles Drew University of Medicine and Science

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Watts Healthcare Corporation

Collaborator

Source ClinicalTrials.gov
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