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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02042807
Recruitment Status : Recruiting
First Posted : January 23, 2014
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Placebo Drug: MCS® Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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®

Primary Outcome Measures :
  1. Cumulative biopsy-detectable prostate cancer rate [ Time Frame: Week 104 (Month 24) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02042807

Contact: Health Ever Bio-Tech Co., Ltd. +886-2-25788621

Department of Urology, National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yeong-Shiau Pu    +886 2 23123456      
Principal Investigator: Yeong-Shiau Pu         
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.

Responsible Party: Health Ever Bio-Tech Co., Ltd. Identifier: NCT02042807     History of Changes
Other Study ID Numbers: MCS-8-II-TWN
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases