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


Phase 2
19 Years
90 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Expression of Ki-67 and p27 biomarkers

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Laurence Klotz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

Canada: Health Canada

Study ID:

REALITY

NCT ID:

NCT01687049

Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • nonmetastatic
  • localized
  • prostate
  • active surveillance
  • Prostatic Neoplasms

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