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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Efficacy evaluated with blood prostate specific antigen (PSA) level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
green tea and quercetin
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
干预措施: green tea and quercetin + docetaxel (Drug)
placebo
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
干预措施: Placebo + docetaxel (Drug)
结局指标
主要结局
Efficacy evaluated with blood prostate specific antigen (PSA) level
时间窗: From enrollment to the end of treatment at 11 weeks
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.
次要结局
- circulating tumor DNA level (ctDNA) analyzed by next generation sequencing(From the start of intervention at 3 weeks to the end of treatment at 11 weeks.)
- tumor burden by CT detection(From the start of intervention at 3 weeks to the end of treatment at 11 weeks.)
- Adverse events graded by using NCI CTCAE criteria(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(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(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)(On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.)
研究者
Piwen Wang
Associate Professor
Charles Drew University of Medicine and Science