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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54MD007598-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Watts Healthcare Corporation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| green tea and quercetin | Experimental | Green tea and quercetin capsules will be administered in combination with docetaxel treatment. |
|
| placebo | Placebo Comparator | Placebo capsules will be administered in combination with docetaxel treatment as comparison. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| green tea and quercetin + docetaxel | Drug | green tea and quercetin supplements in combination with docetaxel infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of intervention at 3 weeks to the end of treatment at 11 weeks. |
| tumor burden by CT detection |
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Inclusion Criteria:
Exclusion Criteria:
only biologically male is eligible for this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piwen Wang, PhD | Contact | 3235634999 | PiwenWang@cdrewu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Piwen Wang, PhD | Charles Drew University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles R. Drew University of Medicine and Science | Recruiting | Los Angeles | California | 90059 | United States |
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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.
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| Placebo + docetaxel | Drug | Placebo will be given along with docetaxel chemotherapy |
|
|
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. |
| 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. | 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. | 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. | 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. | On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| D011794 | Quercetin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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