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

Phase 2RecruitingNCT06615752

Charles Drew University of Medicine and Science99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

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.

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.

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.

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.

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)

The Tmax 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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts