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.
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
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
Sequential
Lisinopril Tablets
DrugThis is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
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.
change in the percentage of patients with positive blood test in urine
percentage of participants who achieve a dose of 20 mg
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University of Rochester
Lead sponsor
Medical College of Wisconsin
Collaborator
