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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426216
Recruitment Status : Unknown
Verified October 2015 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Health Ever Bio-Tech Co., Ltd.
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease
Prostate Cancer

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)

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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
Study Start Date : March 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.



Primary Outcome Measures :
  1. Cumulative histologically proven prostate cancer [ Time Frame: up to 104 weeks ]
    Cumulative histologically proven prostate cancer incidence at 2 years


Biospecimen Retention:   Samples Without DNA
Blood, urine, prostate tissue


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects who are increased risk of prostate cancer
Criteria

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)


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 ClinicalTrials.gov identifier (NCT number): NCT02426216


Contacts
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Contact: Yeong-Shiau Pu 02-23123456 ext 65249 yspu@ntu.edu.tw
Contact: Health Ever Bio-Tech Co., Ltd. +886-25788621 heb@hebiotech.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Test2, Taiwan, test3
Contact: Yeong-Shiau Pu    02-23123456 ext 65249    yspu@ntu.edu.tw   
Contact: Helth Ever Bio-Tech Co., Ltd.    +886-25788621    heb@hebbiotech.com   
Sponsors and Collaborators
National Taiwan University Hospital
Health Ever Bio-Tech Co., Ltd.
Investigators
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Principal Investigator: Yeong-Shiau Pu National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02426216    
Other Study ID Numbers: 201412038RINB
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Keywords provided by National Taiwan University Hospital:
prostate cancer
chemoprevention
biomarker
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases