Viewing Study NCT01687049



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Last Modification Date: 2024-10-26 @ 10:56 AM
Study NCT ID: NCT01687049
Status: UNKNOWN
Last Update Posted: 2012-11-07
First Post: 2012-09-13

Brief Title: Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Sponsor: Dr Laurence Klotz
Organization: Sunnybrook Health Sciences Centre

Study Overview

Official Title: A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Status: UNKNOWN
Status Verified Date: 2012-11
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
SHSC OTHER Urology Research Sunnybrook Health Sciences Centre None