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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
MCS®
Sponsored by
Health Ever Bio-Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Department of Urology, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

MCS® 15 mg/day

MCS® 30 mg/day

Arm Description

placebo arm

MCS® soft capsule

MCS® soft capsule

Outcomes

Primary Outcome Measures

Cumulative biopsy-detectable prostate cancer rate

Secondary Outcome Measures

Full Information

First Posted
January 21, 2014
Last Updated
May 11, 2021
Sponsor
Health Ever Bio-Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02042807
Brief Title
To Evaluate the Effect of MCS® in Prostate Cancer Prevention
Acronym
MCS-8
Official Title
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Ever Bio-Tech Co., Ltd.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
702 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo arm
Arm Title
MCS® 15 mg/day
Arm Type
Active Comparator
Arm Description
MCS® soft capsule
Arm Title
MCS® 30 mg/day
Arm Type
Active Comparator
Arm Description
MCS® soft capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
MCS®
Primary Outcome Measure Information:
Title
Cumulative biopsy-detectable prostate cancer rate
Time Frame
Week 104 (Month 24)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: high-risk subjects of prostate cancer. Male subject with age from 50 to 75 years old. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF). Exclusion Criteria: Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. Subjects with a PSA > 10.0 ng/ml. Subjects with a history of prostate cancer. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. Subjects are considered ineligible for the study as judged by the investigator.
Facility Information:
Facility Name
Department of Urology, National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Effect of MCS® in Prostate Cancer Prevention

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