Prostate CancerNCT02426216
Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
An observational study of Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are increased risk of prostate cancer
Who may be able to join
- 1. Subject of MCS-8 study inclusion criteria of MCS-8 study
- high-risk subjects of prostate cancer.
- Male subject with age from 50 to 75 years old.
- No active urinary tract infection (UTI) or bacterial prostatitis.
- Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).
Who cannot join
- Subjects' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate.
- Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
- Subjects with a PSA > 10.0 ng/ml.
- Subjects with a history of prostate cancer.
- Subjects are currently taking or planning to take oral bile acid sequestrants.
- Subjects have malabsorption conditions.
Show all 12Show fewer
- Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
- Subjects are considered ineligible for the study as judged by the investigator.
- Other malignancies except non-melanoma skin cancer.
- 2. Subject is eligible for MCS-8 study but did not sign up for the MCS-8 study.
- Subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (ICF).
- Note: (MCS-8-TWN-II Clinicaltrials.gov NCT02042807)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, test3
Yeong-Shiau Pu, 02-23123456 ext. 65249, yspu@ntu.edu.tw
Helth Ever Bio-Tech Co., Ltd., +886-25788621, heb@hebbiotech.com
About this study
This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.
Read the detailed description
Many epidemiological studies have shown that nutrients or elements from tomato or other plants, including lycopene and multi-carotenoids, may reduce the risk of prostate cancer, especially those of lethal cancer. Studies have also shown that multi-carotenoids may reduce serum PSA levels in prostate cancer patients. MCS is a patented, multi-carotenoids-rich, purely botanic agent. The investigators' previous Phase II and III clinical trials (US FDA and TFDA, 600 subjects, studies finished, data in analysis) have shown that there were no MCS-related serious adverse events (SAE). MCS may relieve urinary symptoms in men with BPH and PSA was reduced in men with elevated PSA. So, the investigators are initiating a large multi-center phase II randomized study (MCS-8, N=702) in Taiwan, to study if MCS can reduce the risk of prostate cancer. High risk patients will be assigned to take oral daily 30, 15, and 0 (placebo) mg of MCS (1:1:1). The investigators will compare the cumulative prostate cancer incidence among groups and the change from baseline in serum carotenoids levels.
(MCS-8-TWN-II Clinicaltrials.gov NCT02042807)
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, chemoprevention, biomarker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A: Subjects who fullfil all eligibility criteria of the MCS-8 protocol and consent to enroll the study. | |
| Group B | Group B: Subjects who fullfil the definition of elevated risk for prostate cancer by the MCS-8 protocol but did not sign up for the MCS-8 study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative histologically proven prostate cancer
Cumulative histologically proven prostate cancer incidence at 2 years
Measured: up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Ever Bio-Tech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426216
- Sponsor's protocol ID
- 201412038RINB
- Status last verified
- Oct 2015
- First submitted
- 9 Apr 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
- ClinicalTrials.gov ID
- NCT02426216
- Acronym / sponsor ID
- 201412038RINB
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, chemoprevention, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Health Ever Bio-Tech Co., Ltd.
- Study start
- Mar 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- 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.
This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.
Detailed description
Many epidemiological studies have shown that nutrients or elements from tomato or other plants, including lycopene and multi-carotenoids, may reduce the risk of prostate cancer, especially those of lethal cancer. Studies have also shown that multi-carotenoids may reduce serum PSA levels in prostate cancer patients. MCS is a patented, multi-carotenoids-rich, purely botanic agent. The investigators' previous Phase II and III clinical trials (US FDA and TFDA, 600 subjects, studies finished, data in analysis) have shown that there were no MCS-related serious adverse events (SAE). MCS may relieve urinary symptoms in men with BPH and PSA was reduced in men with elevated PSA. So, the investigators are initiating a large multi-center phase II randomized study (MCS-8, N=702) in Taiwan, to study if MCS can reduce the risk of prostate cancer. High risk patients will be assigned to take oral daily 30, 15, and 0 (placebo) mg of MCS (1:1:1). The investigators will compare the cumulative prostate cancer incidence among groups and the change from baseline in serum carotenoids levels.
(MCS-8-TWN-II Clinicaltrials.gov NCT02042807)
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Group A: Subjects who fullfil all eligibility criteria of the MCS-8 protocol and consent to enroll the study. |
| Group B | – | –Group B: Subjects who fullfil the definition of elevated risk for prostate cancer by the MCS-8 protocol but did not sign up for the MCS-8 study. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are increased risk of prostate cancer
Key inclusion criteria (5 listed)
- 1. Subject of MCS-8 study inclusion criteria of MCS-8 study
- high-risk subjects of prostate cancer.
- Male subject with age from 50 to 75 years old.
- No active urinary tract infection (UTI) or bacterial prostatitis.
- Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).
Key exclusion criteria (12 listed)
- Subjects' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate.
- Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
- Subjects with a PSA > 10.0 ng/ml.
- Subjects with a history of prostate cancer.
- Subjects are currently taking or planning to take oral bile acid sequestrants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative histologically proven prostate cancer
Time frame: up to 104 weeks
Cumulative histologically proven prostate cancer incidence at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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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. This study is not recruiting at the moment.
Yeong-Shiau Pu principal investigator
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?
An observational study of 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeong-Shiau Pu (02-23123456 ext. 65249, yspu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative histologically proven prostate cancer (time frame: up to 104 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 27 Oct 2015.