Active, not recruitingNCT02042807MCS-8Updated Jun 13, 2024

To Evaluate the Effect of MCS® in Prostate Cancer Prevention

A Phase 2 interventional study of Placebo and MCS® in Prostate Cancer, sponsored by Health Ever Bio-Tech Co., Ltd.. Active, not recruiting at 1 site in Taiwan. Open to male participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Health Ever Bio-Tech Co., Ltd. · Phase 2, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 2
Study type: Interventional
Enrollment: 702
Allocation: Randomized
Ages: 50 Years to 75 Years
Sex: Male

Study 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.

Conditions studied

Prostate Cancer

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Prostatic Neoplasms 6,370

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 702 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Health Ever Bio-Tech Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 702 participants (estimated)

Study arms

Placebo comparator
Placebo
placebo arm
Drug: Placebo
Active comparator
MCS® 15 mg/day
MCS® soft capsule
Drug: MCS®
Active comparator
MCS® 30 mg/day
MCS® soft capsule
Drug: MCS®

Interventions

DrugPlacebo
DrugMCS®

What researchers measure

Primary outcomes

Cumulative biopsy-detectable prostate cancer rate
Time frame: Week 104 (Month 24)

Study locations

1 site

Department of Urology, National Taiwan University Hospital
Taipei, Taiwan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02042807
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Responsible party: Sponsor
First posted: Jan 23, 2014
Start date: Oct 2014
Primary completion: Dec 2024 (estimated)
Completion: Dec 2024 (estimated)
Last update: Jun 13, 2024

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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