Prostate Cancer Clinical Trial
Official title:
Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
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.
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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