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
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.
Arms & interventions
- Druggreen tea and quercetin + docetaxel
green tea and quercetin supplements in combination with docetaxel infusion
- DrugPlacebo + docetaxel
Placebo will be given along with docetaxel chemotherapy
Outcome measures
Primary
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
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.
Eligibility criteria
Study locations (1)
Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059