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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Red yeast rice

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring nonmetastatic, localized, prostate, active surveillance

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

red yeast rice (RYR)

Arm Description

Two RYR capsules three times daily for a minimum of 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PSA kinetics

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

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

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

Full Information

NCT ID

NCT01687049

First Posted

September 13, 2012

Last Updated

November 6, 2012

Sponsor

Dr. Laurence Klotz

1. Study Identification

Unique Protocol Identification Number

NCT01687049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Laurence Klotz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

nonmetastatic, localized, prostate, active surveillance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

red yeast rice (RYR)

Arm Type

Experimental

Arm Description

Two RYR capsules three times daily for a minimum of 6 months

Intervention Type

Drug

Intervention Name(s)

Red yeast rice

Other Intervention Name(s)

Aliperol

Primary Outcome Measure Information:

Title

Expression of Ki-67 and p27 biomarkers

Description

Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy

Time Frame

6 months

Secondary Outcome Measure Information:

Title

PSA kinetics

Description

Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer

Time Frame

6 months

Title

Presence of prostatic interepithelial neoplasia

Description

To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy

Time Frame

6 months

Title

Expression of hs-CRP and cardiac CRP

Description

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

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marlene Kebabdjian, BA

Phone

416-480-6100

Ext

7939

marlene.kebabdjian@sunnybrook.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurence Klotz, MD

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence Klotz, Md

12. IPD Sharing Statement

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

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