Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention

October 25, 2015 updated by: National Taiwan University Hospital
This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.

Study Overview

Status

Unknown

Conditions

Detailed Description

Many epidemiological studies have shown that nutrients or elements from tomato or other plants, including lycopene and multi-carotenoids, may reduce the risk of prostate cancer, especially those of lethal cancer. Studies have also shown that multi-carotenoids may reduce serum PSA levels in prostate cancer patients. MCS is a patented, multi-carotenoids-rich, purely botanic agent. The investigators' previous Phase II and III clinical trials (US FDA and TFDA, 600 subjects, studies finished, data in analysis) have shown that there were no MCS-related serious adverse events (SAE). MCS may relieve urinary symptoms in men with BPH and PSA was reduced in men with elevated PSA. So, the investigators are initiating a large multi-center phase II randomized study (MCS-8, N=702) in Taiwan, to study if MCS can reduce the risk of prostate cancer. High risk patients will be assigned to take oral daily 30, 15, and 0 (placebo) mg of MCS (1:1:1). The investigators will compare the cumulative prostate cancer incidence among groups and the change from baseline in serum carotenoids levels.

(MCS-8-TWN-II Clinicaltrials.gov NCT02042807)

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yeong-Shiau Pu
  • Phone Number: 65249 02-23123456
  • Email: yspu@ntu.edu.tw

Study Contact Backup

  • Name: Health Ever Bio-Tech Co., Ltd.
  • Phone Number: +886-25788621
  • Email: heb@hebiotech.com

Study Locations

  • Taiwan
    • Test2
      • Taipei, Test2, Taiwan, test3
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Subjects who are increased risk of prostate cancer

Description

Inclusion criteria:

1. Subject of MCS-8 study inclusion criteria of MCS-8 study

  1. 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 of MCS-8 study

  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.
  4. Subjects with a history of prostate cancer.
  5. Subjects are currently taking or planning to take oral bile acid sequestrants.
  6. Subjects have 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.

2. Subject is eligible for MCS-8 study but did not sign up for the MCS-8 study.

Exclusion criteria:

Subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (ICF).

Note: (MCS-8-TWN-II Clinicaltrials.gov NCT02042807)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group A
Group A: Subjects who fullfil all eligibility criteria of the MCS-8 protocol and consent to enroll the study.
Group B
Group B: Subjects who fullfil the definition of elevated risk for prostate cancer by the MCS-8 protocol but did not sign up for the MCS-8 study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative histologically proven prostate cancer
Time Frame: up to 104 weeks
Cumulative histologically proven prostate cancer incidence at 2 years
up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Health Ever Bio-Tech Co., Ltd.

Investigators

  • Principal Investigator: Yeong-Shiau Pu, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 25, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201412038RINB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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