A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Conditions
Prostate Cancer, Radiation Toxicity, Urinary ComplicationDrugs
Lisinopril TabletsSummary
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.
Locations
1 location Found with status Recruiting
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
Study Plan
Control group
NO_INTERVENTION
Patients who receive radiation but no intervention
Intervention group
DRUG:
Lisinopril TabletsDescription:
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
Outcome Measures
Primary Outcome Measures
Mean change in Expanded Prostate Index Composite score
change in the percentage of patients with positive blood test in urine
percentage of participants who achieve a dose of 20 mg
Timeline
Last Updated
February 28, 2024Start Date
September 7, 2022Today
January 16, 2025Completion Date ( Estimated )
January 1, 2026
Sponsors of this trial
Lead Sponsor
University of RochesterCollaborating Sponsors
Medical College of Wisconsin