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A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
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
Who can join
Ages 18 to 70 · Men
Full eligibility criteria
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 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. Exclusion Criteria: * 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
About the study
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.
What is being tested
- Lisinopril Tablets (drug)
Sponsor: University of Rochester · Participants: 30 · Started: Feb 20, 2024
Contact the study team
- Therese Smudzin · Phone: 585-275-7848
Official record on ClinicalTrials.gov — NCT05530655
Locations in the U.S.
| New York | Wilmot Cancer Institute, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.