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
Summary
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.
Arms & interventions
- DrugLisinopril Tablets
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
Outcome measures
Primary
Mean change in Expanded Prostate Index Composite score
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.
Time frame: baseline to 12 months
change in the percentage of patients with positive blood test in urine
Time frame: baseline to 12 months
percentage of participants who achieve a dose of 20 mg
Time frame: 12 months
Eligibility criteria
Study locations (1)
Wilmot Cancer Institute
Rochester, New York, 14642