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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Laurence Klotz
• Treatments: Red yeast rice

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