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
University of Rochester
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.
Eligibility
- Age range
- 18–70 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugLisinopril Tablets
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
Location
- Wilmot Cancer InstituteRochester, New York