A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

Launched by UNIVERSITY OF ROCHESTER · Sep 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called lisinopril can help prevent urinary issues in men with prostate cancer who are receiving radiation therapy. The researchers want to find out the best dose of lisinopril to use and how it affects urinary symptoms and certain biological markers related to these symptoms. The trial is currently looking for men aged 18 to 70 who have been diagnosed with prostate cancer and are planning to undergo radiation treatment.

To participate, individuals must have a specific type of prostate cancer and meet certain health criteria, such as having good kidney function and a stable blood pressure. Participants will take lisinopril during their treatment and will be monitored for any changes in urinary symptoms and overall health. This research is important because it could help improve the quality of life for men undergoing radiation for prostate cancer by reducing urinary complications.

Gender

MALE

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