To Evaluate the Effect of MCS® in Prostate Cancer Prevention

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02042807

Acronym

MCS-8

Enrollment

702

Registered

2014-01-23

Start date

2014-10-31

Completion date

2024-12-31

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

Interventions

DRUGPlacebo

DRUGMCS®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. high-risk subjects of prostate cancer. 2. Male subject with age from 50 to 75 years old. 3. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

Exclusion criteria

1. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. 2. Subjects with a PSA \> 10.0 ng/ml. 3. Subjects with a history of prostate cancer. 4. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. 5. Subjects are considered ineligible for the study as judged by the investigator.

Design outcomes

Primary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026