A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Expression of Ki-67 and p27 biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
red yeast rice (RYR)
Two RYR capsules three times daily for a minimum of 6 months
干预措施: Red yeast rice (Drug)
结局指标
主要结局
Expression of Ki-67 and p27 biomarkers
时间窗: 6 months
Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
次要结局
- PSA kinetics(6 months)
- Presence of prostatic interepithelial neoplasia(6 months)
- Expression of hs-CRP and cardiac CRP(6 months)
研究者
Dr. Laurence Klotz
Principal Investigator
Sunnybrook Health Sciences Centre