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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Red yeast rice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically diagnosis of prostate adenocarcinoma being monitored by active surveillance for favourable risk prostate cancer tumour material from most recent prostate biopsy available with sample scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study Exclusion Criteria: previous malignancy in the past 5 years no previous or concurrent treatment for prostate cancer inability to undergo TRUS biopsy ECOG > 2 known or previous history of liver disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: red yeast rice (RYR)<br>Two RYR capsules three times daily for a minimum of 6 months | Drug: Red yeast rice<br> <br> * Other names: Aliperol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of Ki-67 and p27 biomarkers | Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA kinetics | Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer | 6 months | 
| Presence of prostatic interepithelial neoplasia | To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy | 6 months | 
| Expression of hs-CRP and cardiac CRP | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonmetastatic, localized, prostate, active surveillance