A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
研究概览
简要总结
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer
详细描述
Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- •Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
- •Age at least 18 years
- •Karnofsky Performance Status (KPS) ≥ 70
- •No history of prior radiotherapy to the prostate or rectum
- •History of prior malignancy, if likely to live at least 4 years, is acceptable.
- •No evidence of distant metastases
- •Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
- •Creatine kinase < 5 times upper normal limit
- •Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
- •transaminases < 3 times upper normal limit
排除标准
- •Planned abdomino-perineal resection after radiotherapy
- •Contraindication to an HMG-coA-reductase inhibitor
- •Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- •Currently taking an inhibitor of cytochrome P450 3A4
- •Active liver or muscle disease
研究组 & 干预措施
Lovastatin for 1 yr
Lovastatin (20-80 mg/d) was started on day 1 of radiation and continued for 12 months. Patients were followed for an additional 12 months. Lovastatin once per day for 1 year. After the implant, they are asked to return for checkups (study visits 4-13) 4 weeks, 8 weeks, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months after the procedure. At 8 weeks, 4 months, 6 months, 9 months and 12 months, will also have a blood test to check their liver.
干预措施: lovastatin (Drug)
结局指标
主要结局
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
时间窗: 24 months
The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power.
次要结局
未报告次要终点