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

NCT ID: NCT01687049

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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nonmetastatic localized prostate active surveillance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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red yeast rice (RYR)

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

Group Type EXPERIMENTAL

Red yeast rice

Intervention Type DRUG

Interventions

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Red yeast rice

Intervention Type DRUG

Other Intervention Names

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Aliperol

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Laurence Klotz

OTHER

Sponsor Role lead

Responsible Party

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Dr. Laurence Klotz

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Laurence Klotz, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Marlene Kebabdjian, BA

Role: CONTACT

Phone: 416-480-6100

Email: [email protected]

Other Identifiers

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SHSC

Identifier Type: OTHER

Identifier Source: secondary_id

REALITY

Identifier Type: -

Identifier Source: org_study_id