Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Jan 2013
Typical duration for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 7, 2012
November 1, 2012
4.9 years
September 13, 2012
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
PSA kinetics
6 months
Presence of prostatic interepithelial neoplasia
6 months
Expression of hs-CRP and cardiac CRP
6 months
Study Arms (1)
red yeast rice (RYR)
EXPERIMENTALTwo RYR capsules three times daily for a minimum of 6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurence Klotz, MD
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 7, 2012
Record last verified: 2012-11