- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03237702
Decipher Lethal Prostate Cancer Biology - Urine Metabolomics
Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
In Cohort A, sPC (Group 2), isPC (Group 3), ASAP/PIN (Group 4) and benign pathology patients (Group 5) will further be invited to take MCS supplementation for 8 weeks after the pathology confirmation. The expected enrollment number is 30 for each of the 4 groups (in total 120). Urine samples will be collected before and after 8 weeks of MCS supplementation for metabolomics and proteomics analysis. The effect of MCS supplementation in modifying urine metabolites will be investigated to determine the potential use of MCS in prostate cancer chemoprevention.
Through a better understanding of the biology of significant (lethal) PC, we hope to develop new markers/targets for more effective screening and prevention of sPC. In the meantime, with these new markers we may substantially reduce overtreatment of insignificant PC.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chung-Hsin Chen, MD PhD
- Phone Number: 65242 +886-23123456
- Email: mufasachen@gmail.com
Study Contact Backup
- Name: Yeong-Shiau Pu, MD PhD
- Phone Number: 65254 +886-23123456
- Email: pu5249@ntuh.gov.tw
Study Locations
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-
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Taipei, Taiwan, 100
- Recruiting
- Department of Urology, National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MCS arm
The participants who will have Multi-Carotenoids for 8 weeks The intervention is Multi-Carotenoids 30 mg for 8 weeks.
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All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of urine metabolomics
Time Frame: 8 weeks
|
Observe the change of metabolomics in urine samples collected before and upon the completeness of MCS supplementation
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yeong-Shiau Pu, MD PhD, Department of Urology, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201705040MIPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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