Decipher Lethal Prostate Cancer Biology - Urine Metabolomics
NCT ID: NCT03237702
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2017-08-01
2025-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
In addition, 20 men and 20 women will be enrolled as a healthy control without any further medication.
SCREENING
NONE
Study Groups
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MCS arm
The participants who will have Multi-Carotenoids for 8 weeks The intervention is Multi-Carotenoids 30 mg for 8 weeks.
Multi-Carotenoids
All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.
Interventions
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Multi-Carotenoids
All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who are aged between 30 and 100 years men.
3. For subjects who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
4. 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
2. 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.
3. 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.
4. Subjects who have been treated with pelvic radiotherapy within 3 months of the screening.
5. Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
6. Subjects who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
7. Topical or oral prednisolone equivalent dosage larger 10 mg per day for 14 days or more.
8. The last dose of prednisolone is within 4 weeks of the biopsy.
9. Subjects who have a life expectancy less than 12 months.
10. 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.
30 Years
100 Years
MALE
No
Sponsors
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Taipei Medical University Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Cardinal Tien Hospital
OTHER
Taipei Medical University Shuang Ho Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
Taichung Tzu Chi Hospital
OTHER
Shin Kong Wu Ho-Su Memorial Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yeong-Shiau Pu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, National Taiwan University Hospital
Locations
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Department of Urology, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chung-Hsin Chen, MD PhD
Role: primary
Yeong-Shiau Pu, MD PhD
Role: backup
Other Identifiers
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201705040MIPB
Identifier Type: -
Identifier Source: org_study_id