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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01687049
First received: September 13, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Red yeast rice
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Expression of Ki-67 and p27 biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy


Secondary Outcome Measures:
  • PSA kinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Expression of hs-CRP and cardiac CRP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: red yeast rice (RYR)
Two RYR capsules three times daily for a minimum of 6 months
Drug: Red yeast rice
Other Name: Aliperol

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687049

Contacts
Contact: Marlene Kebabdjian, BA 416-480-6100 ext 7939 marlene.kebabdjian@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Laurence Klotz, Md         
Sponsors and Collaborators
Dr. Laurence Klotz
Investigators
Principal Investigator: Laurence Klotz, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Laurence Klotz, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01687049     History of Changes
Other Study ID Numbers: REALITY, SHSC
Study First Received: September 13, 2012
Last Updated: November 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
nonmetastatic
localized
prostate
active surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Red yeast rice
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014