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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 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: NA
Last verified: January 2014
History: No changes posted
  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
1. High-risk Subjects of Prostate Cancer
Drug: Placebo
Drug: MCS®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 702
Study Start Date: April 2014
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® 15 mg/day, soft capsule
Drug: MCS®
Active Comparator: MCS® 30 mg/day
MCS® 30 mg/day, soft capsule
Drug: MCS®

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Four groups of high-risk subjects of prostate cancer. (2) Male subject with age from 50 to 75 years old. (3) No active urinary tract infection (UTI) or bacterial prostatitis. (4) 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' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate.

    (2) Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.

    (3) Subjects with a PSA > 10.0 ng/ml. I (4) Subjects with a history of prostate cancer. (5) Subjects are currently taking or planning to take oral bile acid sequestrants.

    (6) Subjects have celiac disease, Crohn's disease, partly removal of the intestinal tract (surgically), or any malabsorption conditions.

    (7) Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.

    (8) Subjects are considered ineligible for the study as judged by the investigator.

    (9) Other malignancies except non-melanoma skin cancer.

  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: Fu-Feng Kuo +886 2 25788621

Locations
Taiwan
Department of Urology, National Taiwan University Hospital Not yet 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

No publications provided

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: January 21, 2014
Health Authority: Taiwan: Taiwan Food and Drug Administration

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 July 23, 2014