A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
- 试验地点
- 353
- 主要终点
- Change in the highest percent Ki-67 expression
研究概览
简要总结
This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.
详细描述
PRIMARY OBJECTIVE:
I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea catechins (GTCs) or placebo for 6 months.
SECONDARY OBJECTIVES:
I. To assess apoptosis by caspase in tumor tissue from EOS biopsy by treatment. II. To assess % Ki-67: Apoptosis ratio from EOS biopsy by treatment. III. To evaluate the number of biopsy cores positive for cancer from EOS biopsy by treatment.
IV. To evaluate the percentage of any biopsy tissue core positive for cancer from EOS biopsy by treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
- •Patient must have biopsy-proven (consisting of >= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy
- •Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network [NCCN])
- •Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study
- •Patient must have a serum PSA < 10 ng/mL or prostate specific antigen density (PSAD) < 0.15 ng/mL/ g obtained within 30 days of registration
- •Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patient must be willing to abstain from consumption of any supplements containing green tea catechins
- •Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz)
- •Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study
- •Patient must be willing to take study agent or placebo at the dose specified with meals
- •Patient must have the ability to understand and the willingness to sign a written informed consent document
- •Absolute neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL) (obtained within 30 days prior to registration)
- •Platelets >= 75,000/mm^3 (>= 75 k/uL) (obtained within 30 days prior to registration)
- •Total bilirubin =< 1.2 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration)
- •Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration)
- •Serum creatinine =< 1.5 x ULN (obtained within 30 days prior to registration)
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- •Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study
- •Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening
- •Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center & Research Institute
- •H. Lee Moffitt Cancer Center & Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen
- •INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1)
- •Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1
- •Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =< 33% of biopsy cores, and =< 50% involvement of any biopsy core
- •Patient must have % Ki-67 expression of 5% or more in tumor tissue
排除标准
- •EXCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
- •Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy
- •Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C
- •Patient must not have prostate cancer with distant metastases
- •Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- •Patient must not receive any other investigational agents while on this study
- •Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts
研究组 & 干预措施
Arm A (green tea catechins)
Patients receive green tea catechins PO BID for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm A (green tea catechins)
Patients receive green tea catechins PO BID for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm B (placebo)
Patients receive placebo PO BID for up to 6 months.
干预措施: Quality-of-Life Assessment (Other)
Arm B (placebo)
Patients receive placebo PO BID for up to 6 months.
干预措施: Placebo Administration (Drug)
Arm B (placebo)
Patients receive placebo PO BID for up to 6 months.
干预措施: Questionnaire Administration (Other)
Arm A (green tea catechins)
Patients receive green tea catechins PO BID for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Sinecatechins (Drug)
结局指标
主要结局
Change in the highest percent Ki-67 expression
时间窗: Baseline to 6 months
Measured in a core positive for tumor from baseline to highest percent (%) Ki-67 expression measured in a core positive for tumor in the end of study (EOS) biopsy. This change will be compared between green tea catechins (GTC) and placebo arms. The highest % Ki-67 expressions from baseline and EOS biopsies will be used to estimate the change. If the change is not normally distributed, non-parametric test such as Wilcoxon-rank sum test or two-sample normal score test will be used to compare the changes in percent Ki-67 levels between the GTC and placebo arms.
次要结局
- Apoptosis(Up to 6 months)
- Apoptosis ratio(Up to 6 months)
- Number of biopsy cores positive for cancer at end of study(At 6 months)
- Percent of any biopsy tissue core positive for cancer at end of study(At 6 months)
- Percent Ki-67(Up to 6 months)
- Gleason sum at end of study(At 6 months)
- Change in serum prostate-specific antigen (PSA)(Baseline up to 6 months)
- Incidence of adverse events(Up to 12 months)
- Change in geometric mean of percent Ki-67(Baseline up to 6 months)