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

NCT02426216 | Unknown

• 1 other identifier: 201412038RINB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; chemoprevention; biomarker

Outcome Measures

Primary Outcomes (1)

• Cumulative histologically proven prostate cancer

  Cumulative histologically proven prostate cancer incidence at 2 years

  up to 104 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who are increased risk of prostate cancer

You may qualify if:

• high-risk subjects of prostate cancer.
• Male subject with age from 50 to 75 years old.
• No active urinary tract infection (UTI) or bacterial prostatitis.
• Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

You may not qualify if:

• Subjects' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate.
• Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
• Subjects with a PSA \> 10.0 ng/ml.
• Subjects with a history of prostate cancer.
• Subjects are currently taking or planning to take oral bile acid sequestrants.
• Subjects have malabsorption conditions.
• Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
• Subjects are considered ineligible for the study as judged by the investigator.
• Other malignancies except non-melanoma skin cancer.
• \. Subject is eligible for MCS-8 study but did not sign up for the MCS-8 study.
• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Health Ever Bio-Tech Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, prostate tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yeong-Shiau Pu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong-Shiau Pu

CONTACT

02-23123456; yspu@ntu.edu.tw

Health Ever Bio-Tech Co., Ltd.

CONTACT

+886-25788621; heb@hebiotech.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 24, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

TW (1)