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NCT02042807 Clinical Trial

To Evaluate the Effect of MCS® in Prostate Cancer Prevention

Prostate Cancer Clinical Trial

— MCS-8  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02042807
Other study ID # MCS-8-II-TWN
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date December 2024

Study information
Verified date June 2024
Source Health Ever Bio-Tech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 702
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo

• MCS®

Locations
Country Name City State
Taiwan Department of Urology, National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Health Ever Bio-Tech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative biopsy-detectable prostate cancer rate Week 104 (Month 24)
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