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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат green tea and quercetin + docetaxel
  green tea and quercetin supplements in combination with docetaxel infusion
• Препарат Placebo + docetaxel
  Placebo will be given along with docetaxel chemotherapy

Первичные конечные точки

• Efficacy evaluated with blood prostate specific antigen (PSA) level [Срок оценки: From enrollment to the end of treatment at 11 weeks]

Вторичные конечные точки (6)

• circulating tumor DNA level (ctDNA) analyzed by next generation sequencing [Срок оценки: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.]
• tumor burden by CT detection [Срок оценки: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.]
• Adverse events graded by using NCI CTCAE criteria [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Charles R. Drew University of Medicine and Science — Los Angeles

Идентификаторы

NCT: NCT06615752 · 2188250-3 · 2U54MD007598-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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