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

Prostate Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01687049
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Contact: Marlene Kebabdjian, BA
• Phone: 416-480-6100
• Email: marlene.kebabdjian@sunnybrook.ca
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2013
• Completion date: December 2017