Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
|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
|Condition or disease|
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|
|Estimated Enrollment :||300 participants|
|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|
Group A: Subjects who fullfil all eligibility criteria of the MCS-8 protocol and consent to enroll the study.
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426216
|Contact: Yeong-Shiau Pu||02-23123456 ext email@example.com|
|Contact: Health Ever Bio-Tech Co., Ltd.||+firstname.lastname@example.org|
|Principal Investigator:||Yeong-Shiau Pu||National Taiwan University Hospital|