Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Change of urine metabolomics
研究概览
简要总结
Through a better understanding of the biology of significant (lethal) prostate cancer, we hope to develop new markers/targets from urine metabolomics for more effective screening and prevention of significant prostate cancer. In the meantime, with these new markers we may substantially reduce overtreatment of insignificant PC.
详细描述
Prostate cancer (PC) afflicts millions of men worldwide. In Taiwan, around 5,000 men are diagnosed as PC while 1,200 men die of the disease each year. However, thousands of Taiwanese men may have been over-treated for their insignificant PCs. The above situations signify the unmet clinical need where effective measures of stratifying risk of PC are lacking. The study is to identify new markers/targets with which to better screen and prevent significant (sPC) or lethal PC (lePC).
This is a prospective, observational and investigational study investigating the role of urine omics studies (metabolomics and proteomics) in subjects who will undergo prostate biopsy or have completed biopsy and/or subsequent MCS supplementation. MCS (or Botreso) is a new patented botanic agent, composed of primarily multi-carotenoids, including lycopene, phytoene, phytofluene, etc. The expected subject number to be enrolled is 620 men and 20 women from NTUH. There will be 3 cohorts: Cohort A (N=990), Cohort B (N=990) and Cohort C (N=40). Cohort A will be the training cohort used to generate the predictive model. Cohort B will be the validation cohort used to validate the newly developed predictive model. Cohort C is the control cohort, including 20 women and 20 men without any signs of cancers.
By risk stratification after biopsy pathology results are available, there will be 5 groups of subjects, including patients with Group 1. mPC: Metastatic prostate cancer Group 2. sPC: Non-metastatic significant prostate cancer (sPC) Group 3. isPC: Non-metastatic insignificant PC (isPC) Group 4. Pre-cancerous lesions: atypical small acinar proliferation (ASAP) or prostatic intraepithelial neoplasia (PIN) Group 5. Non-cancer benign pathology
Based on NCCN risk classification, sPC is defined as the followings: unfavorable intermediate-risk, high/very high-risk, or presence of metastasis. The patients with favorable intermediate-risk prostate cancer will be considered as sPC in the prediction model in the population with long life expectancy.
Biopsy pathology report and clinicopathological parameters will be recorded. In addition, transcriptomics study will be performed. Group specific urine omics profiles will be constructed by comparing the outstanding metabolites between groups. These urine omics profiles are constructed so as to efficiently separate groups of graded risk stratification, especially to predict subjects with mPC (Group 1) or sPC (Group 2). The newly constructed urine omics profiles from Cohort A will be validated against Cohort B of subjects who will undergo biopsy to determine the predictive efficiency of the constructed profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
- •Subjects who are aged between 30 and 100 years men.
- •For subjects who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone >1.5 ng/ml).
- •Subjects who understand the entire study procedures and consent to donate his spot urine (once for 50 ml) and agree with subsequent analyses of his clinical information including biopsy results, treatments and outcomes. (Note: Subjects will be told that the urine metabolomics results will not be revealed to them.)
排除标准
- •Subjects who have other active cancers. However, subjects who have cancers that have been curatively treated and who are disease-free for 3 years or longer are allowed to be enrolled.
- •Subjects who have severe organ function impairment which may significantly alter general cell metabolism determined by the investigators, such as or Cre > 3.0, HbA1c > 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases.
- •Subjects who are receiving or have received systemic therapy, such as chemotherapy, androgen deprivation therapy (ADT), immunotherapy, or targeted therapy within 3 months of the screening.
- •Subjects who have been treated with pelvic radiotherapy within 3 months of the screening.
- •Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
- •Subjects who have pyuria (defined as > 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
- •Topical or oral prednisolone equivalent dosage larger 10 mg per day for 14 days or more.
- •The last dose of prednisolone is within 4 weeks of the biopsy.
- •Subjects who have a life expectancy less than 12 months.
- •Subjects who use MCS or found supplementation containing large amount of lycopene in recent 60 days or less. The definition of large amount of lycopene is more than 2 mg per day.
结局指标
主要结局
Change of urine metabolomics
时间窗: 8 weeks
Observe the change of metabolomics in urine samples collected before and upon the completeness of MCS supplementation
次要结局
未报告次要终点