To Evaluate the Effect of MCS® in Prostate Cancer Prevention

NCT ID: NCT02042807

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

MCS® 15 mg/day

MCS® soft capsule

Group Type ACTIVE_COMPARATOR

MCS®

Intervention Type DRUG

MCS® 30 mg/day

MCS® soft capsule

Group Type ACTIVE_COMPARATOR

MCS®

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

MCS®

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Health Ever Bio-Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Urology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MCS-8-II-TWN

Identifier Type: -

Identifier Source: org_study_id

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