To Evaluate the Effect of MCS® in Prostate Cancer Prevention

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: MCS®

• Registration Number: NCT02042807
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 702

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo arm
MCS® 15 mg/day	MCS®	MCS® soft capsule
MCS® 30 mg/day	MCS®	MCS® soft capsule

Primary Outcome Measures

Name	Time	Method
Cumulative biopsy-detectable prostate cancer rate	Week 104 (Month 24)

Trial Locations

Locations (1)

Department of Urology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan