A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- percentage of participants who achieve a dose of 20 mg
研究概览
简要总结
This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.
- •Be stage M0 based on the standard of care staging imaging
- •Be able to read English
- •Have the psychological ability and general health that permits completion of the study requirements and required follow up
- •Be ≥18 and < 70 years of age
- •Have ECOG performance status of 0 to 2 within 180 days prior to enrollment
- •Have adequate renal function with creatinine clearance > 30 mL/min within 30 days prior to registration
- •Have hematologic and hepatic function deemed adequate for planned treatment by the treating investigator within 90 days prior to registration, including:
- •hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors
- •platelet count ≥100,000/µL independent of transfusion and/or growth factors
- •Have a baseline systolic blood pressure of >130.
排除标准
- •Have received prior pelvic radiotherapy
- •Be taking lisinopril or other RAS modifying drug within two months prior to registration
- •Have had a prior allergic reaction to lisinopril
研究组 & 干预措施
Intervention group
干预措施: Lisinopril Tablets (Drug)
Control group
Patients who receive radiation but no intervention
结局指标
主要结局
percentage of participants who achieve a dose of 20 mg
时间窗: 12 months
Mean change in Expanded Prostate Index Composite score
时间窗: baseline to 12 months
Patient reported outcomes capturing urinary symptoms will be collected using the Expanded Prostate Index Composite (EPIC) patient reported outcome questionnaire prior to radiation on the first day of treatment, weekly during radiation, and approximately 1 month, 3 months, 6 months, and 12 months after radiation. The EPIC bladder domain score will quantify patient reported urinary symptoms. The EPIC bladder domain consists of 12 items each scored on a Likert scale with an overall score transformed to a 0-100 scale. A higher score indicates worse outcome.
change in the percentage of patients with positive blood test in urine
时间窗: baseline to 12 months
次要结局
未报告次要终点
研究者
Hong Zhang
Professor
University of Rochester