To Evaluate the Effect of MCS® in Prostate Cancer Prevention (MCS-8)

Health Ever Bio-Tech

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: MCS®; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02042807

MCS-8-II-TWN

Details and patient eligibility

About

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.

Enrollment: 702 estimated patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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702 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo arm

Treatment:

Drug: Placebo

MCS® 15 mg/day

Active Comparator group

Description:

MCS® soft capsule

Treatment:

Drug: MCS®

MCS® 30 mg/day

Active Comparator group

Description:

MCS® soft capsule

Treatment:

Drug: MCS®