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

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.

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.