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

• Conditions: Prostate Cancer

• Registration Number: NCT02426216
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-25
• Last Update Posted: 2015-10-27
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative histologically proven prostate cancer	up to 104 weeks	Cumulative histologically proven prostate cancer incidence at 2 years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Test2, Taiwan