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

• Sponsor: Health Ever Bio-Tech Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02042807
• Collaborator: (none)
• Enrollment: 702
• Location: 1
• Arms: 3
• Duration (Months): 110
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Placebo; Drug: MCS®	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 702 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
• Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo placebo arm	Drug: Placebo
Active Comparator: MCS® 15 mg/day MCS® soft capsule	Drug: MCS®
Active Comparator: MCS® 30 mg/day MCS® soft capsule	Drug: MCS®

Outcome Measures

Primary Outcome Measures

1. Cumulative biopsy-detectable prostate cancer rate [Week 104 (Month 24)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Health Ever Bio-Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Health Ever Bio-Tech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02042807
• Other Study ID Numbers: MCS-8-II-TWN
• First Posted: Jan 23, 2014
• Last Update Posted: May 13, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of May 13, 2021