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

Dr. Laurence Klotz

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Red yeast rice

Study type: Interventional

Funder types: Other

Identifiers

NCT01687049

SHSC (Other Identifier)

REALITY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 19 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

red yeast rice (RYR)

Experimental group

Description:

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

Treatment:

Drug: Red yeast rice