Significant Prostate CancerNCT03237702
Decipher Lethal Prostate Cancer Biology - Urine Metabolomics
A study testing Multi-Carotenoids in people with Significant Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 100 years, men only
- Conditions the study is for
- Significant Prostate Cancer
- What is being tested?
- Multi-Carotenoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Urology, National Taiwan University Hospital
Taipei, 100
Chung-Hsin Chen, MD PhD, 886-2-23123456 ext. 65242, mufasachen@gmail.com
Yeong-Shiau Pu, MD PhD, 886-2-23123456 ext. 65254, pu5249@ntuh.gov.tw
About this study
Official title: Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
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.
Read the 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.
- Conditions
- Significant Prostate Cancer
- Being tested
- Multi-Carotenoids
- Keywords
- prostate cancer, prostate biopsy, biomarkers, metabolomics, overtreatment, cancer screening, urine, lycopene, proteomics, urine omics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-CarotenoidsDietary supplement
All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MCS arm | Experimental | The participants who will have Multi-Carotenoids for 8 weeks The intervention is Multi-Carotenoids 30 mg for 8 weeks. Receives: Dietary Supplement: Multi-Carotenoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urine metabolomics
Observe the change of metabolomics in urine samples collected before and upon the completeness of MCS supplementation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Significant Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A total of 1,980 male patients who are planning to have prostate biopsy will be enrolled in the first stage of this study for measuring urine metabolomics. Only the patients who have non-metastatic significant prostate cancer, insignificant prostate cancer, ASAP/PIN, or benign prostate proved by prostate biopsy are enrolled into the second stage in which MCS supplementation will be used for 8 weeks. In addition, 20 men and 20 women will be enrolled as a healthy control without any further medication.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, Taipei Veterans General Hospital, Taiwan, Cardinal Tien Hospital, Taipei Medical University Shuang Ho Hospital, Far Eastern Memorial Hospital, Taichung Tzu Chi Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, MD PhD, Principal investigator, Department of Urology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237702
- Sponsor's protocol ID
- 201705040MIPB
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2017
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
- ClinicalTrials.gov ID
- NCT03237702
- Acronym / sponsor ID
- 201705040MIPB
- Conditions
- Significant Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, biomarkers, metabolomics, overtreatment, cancer screening, urine, lycopene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, Taipei Veterans General Hospital, Taiwan, Cardinal Tien Hospital, Taipei Medical University Shuang Ho Hospital, Far Eastern Memorial Hospital, Taichung Tzu Chi Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Chang Gung Memorial Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of 1,980 male patients who are planning to have prostate biopsy will be enrolled in the first stage of this study for measuring urine metabolomics. Only the patients who have non-metastatic significant prostate cancer, insignificant prostate cancer, ASAP/PIN, or benign prostate proved by prostate biopsy are enrolled into the second stage in which MCS supplementation will be used for 8 weeks. In addition, 20 men and 20 women will be enrolled as a healthy control without any further medication.
| Arm | Type | Receives |
|---|---|---|
| MCS arm | Experimental | Dietary Supplement: Multi-CarotenoidsThe participants who will have Multi-Carotenoids for 8 weeks The intervention is Multi-Carotenoids 30 mg for 8 weeks. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-CarotenoidsAll participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks. | Dietary supplement | MCS arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yeong-Shiau Pu, MD PhD principal investigator
Department of Urology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Carotenoids in people with Significant Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung-Hsin Chen, MD PhD (+886-23123456 ext. 65242, mufasachen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of urine metabolomics (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.