Prostate Cancer
Conditions
Keywords
nonmetastatic, localized, prostate, active surveillance
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.
Detailed 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.
Interventions
DRUGRed yeast rice
Sponsors
Dr. Laurence Klotz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expression of Ki-67 and p27 biomarkers | 6 months | Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA kinetics | 6 months | Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer |
| Presence of prostatic interepithelial neoplasia | 6 months | To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy |
| Expression of hs-CRP and cardiac CRP | 6 months | To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum |
Countries
Canada
Contacts
Primary ContactMarlene Kebabdjian, BA
Outcome results
None listed