Clinical trial NCT06615752: Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Keywords: green tea
quercetin
docetaxel
prostate cancer
phase II
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Watts Healthcare Corporation
First posted: 2024-09-27
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy evaluated with blood prostate specific antigen (PSA) level
timeFrame: From enrollment to the end of treatment at 11 weeks
Secondary outcomes:
measure: circulating tumor DNA level (ctDNA) analyzed by next generation sequencing
timeFrame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
measure: tumor burden by CT detection
timeFrame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
measure: Adverse events graded by using NCI CTCAE criteria
timeFrame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
measure: Area under curve (AUC) of blood green tea, quercetin, and docetaxel
timeFrame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
measure: Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel
timeFrame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
measure: Time taken to reach the maximum concentration (Tmax)
timeFrame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Piwen Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: