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Red yeast rice

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Red Yeast

Two RYR capsules three times daily for a minimum of 6 months

Marlene Kebabdjian, BA

Laurence Klotz, Md

Laurence Klotz, MD

Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.

Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for the use of RYR in patients being managed with active surveillance for localized, low risk, prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.

Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy

Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer

To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy

To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum

Dr. Laurence Klotz

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance	NCT01687049	Prostate Cancer	Red yeast rice	19 Years - 90 Years	Sunnybrook Health Sciences Centre
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance	NCT01687049	Prostate Cancer	Red yeast rice	19 Years - 90 Years	Sunnybrook Health Sciences Centre

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