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Trial record 1 of 37 for:    prostate cancer prevention | Recruiting, Not yet recruiting, Available Studies
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To Evaluate the Effect of MCS® in Prostate Cancer Prevention (MCS-8)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2015 by Health Ever Bio-Tech Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02042807
First received: January 21, 2014
Last updated: April 13, 2015
Last verified: April 2015
  Purpose
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 Intervention Phase
Prostate Cancer Drug: Placebo Drug: MCS® Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Health Ever Bio-Tech Co., Ltd.:

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

Estimated Enrollment: 702
Study Start Date: October 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042807

Contacts
Contact: Health Ever Bio-Tech Co., Ltd. +886-2-25788621 heb@hebiotech.com

Locations
Taiwan
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.
  More Information

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02042807     History of Changes
Other Study ID Numbers: MCS-8-II-TWN
Study First Received: January 21, 2014
Last Updated: April 13, 2015

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

ClinicalTrials.gov processed this record on June 28, 2017