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

University of Rochester

Status and phase

Enrolling

Early Phase 1

Conditions

Radiation Toxicity

Urinary Complication

Prostate Cancer

Treatments

Drug: Lisinopril Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT05530655

STUDY00007510_URGUP23077

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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