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

November 6, 2012 updated by: Dr. Laurence Klotz

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: red yeast rice (RYR)
Two RYR capsules three times daily for a minimum of 6 months
Drug: Red yeast rice
Other Names:
  • Aliperol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of Ki-67 and p27 biomarkers
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 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
6 months
Expression of hs-CRP and cardiac CRP
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Laurence Klotz

Investigators

  • Principal Investigator: Laurence Klotz, MD, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REALITY
  • SHSC (Other Identifier: Urology Research, Sunnybrook Health Sciences Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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