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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01687049
• Other study ID #: REALITY
• Secondary ID: SHSC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 13, 2012
• Last updated: November 6, 2012
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: Marlene Kebabdjian, BA
• Phone: 416-480-6100
• Email: marlene.kebabdjian[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 90 Years

Eligibility

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 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

Intervention

Drug:
• Red yeast rice

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Laurence Klotz

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of Ki-67 and p27 biomarkers	Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy	6 months	No
Secondary	PSA kinetics	Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer	6 months	No
Secondary	Presence of prostatic interepithelial neoplasia	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	No
Secondary	Expression of hs-CRP and cardiac CRP	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	No
Secondary	Expression of hs-CRP and cardiac CRP	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	Yes