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

June 11, 2024 updated by: Health Ever Bio-Tech Co., Ltd.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

702

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Urology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative biopsy-detectable prostate cancer rate
Time Frame: Week 104 (Month 24)
Week 104 (Month 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Ever Bio-Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimated)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCS-8-II-TWN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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