Prostate CancerPhase 2MCS-8NCT02042807
To Evaluate the Effect of MCS® in Prostate Cancer Prevention
A Phase 2 study testing MCS® in people with Prostate Cancer, run by Health Ever Bio-Tech Co., Ltd. at 1 site in Taiwan.
Trial summary
To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MCS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 702 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Dec 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high-risk subjects of prostate cancer.
- Male subject with age from 50 to 75 years old.
- 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 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.
- Conditions
- Prostate Cancer
- Being tested
- Placebo, MCS®
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
MCS®Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo arm Receives: Drug: Placebo |
| MCS® 15 mg/day | Active comparator | MCS® soft capsule Receives: Drug: MCS® |
| MCS® 30 mg/day | Active comparator | MCS® soft capsule Receives: Drug: MCS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative biopsy-detectable prostate cancer rate
Measured: Week 104 (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042807
- Sponsor's protocol ID
- MCS-8-II-TWN
- Acronym
- MCS-8
- Status last verified
- Jun 2024
- First submitted
- 21 Jan 2014
- Last updated
- 13 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
- ClinicalTrials.gov ID
- NCT02042807
- Acronym / sponsor ID
- MCS-8 / MCS-8-II-TWN
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 702 participants (estimated)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Jan 2014 (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.
To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo arm |
| MCS® 15 mg/day | Active comparator | Drug: MCS®MCS® soft capsule |
| MCS® 30 mg/day | Active comparator | Drug: MCS®MCS® soft capsule |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- high-risk subjects of prostate cancer.
- Male subject with age from 50 to 75 years old.
- Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).
Key exclusion criteria (5 listed)
- 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.
- 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.
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| MCS® | Drug | MCS® 15 mg/day, MCS® 30 mg/day |
Primary outcome
Cumulative biopsy-detectable prostate cancer rate
Time frame: Week 104 (Month 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCS® in people with Prostate Cancer, run by Health Ever Bio-Tech Co., Ltd. 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 3 inclusion and 5 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 13 Jun 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative biopsy-detectable prostate cancer rate (time frame: Week 104 (Month 24)). 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 13 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.