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

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: Red yeast rice

• Registration Number: NCT01687049
• Lead Sponsor: Dr. Laurence Klotz

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07
• Study Start: 2013-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
red yeast rice (RYR)	Red yeast rice	Two RYR capsules three times daily for a minimum of 6 months

Primary Outcome Measures

Name	Time	Method
Expression of Ki-67 and p27 biomarkers	6 months	Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada