Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
This study is not yet open for participant recruitment.
Verified November 2012 by Sunnybrook Health Sciences Centre
Sponsor:
Dr. Laurence Klotz
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
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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
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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Red yeast rice Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013