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

Clinicaltrials.gov ID: NCT05530655
db-list-check Status RECRUITING
b-loader Phase EARLY_PHASE1
b-people Age 18 - 70 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer, Radiation Toxicity, Urinary Complication

Drugs

Lisinopril Tablets

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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 Tablets

    Description:

    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

Time Frame: baseline to 12 months

change in the percentage of patients with positive blood test in urine

Time Frame: baseline to 12 months

percentage of participants who achieve a dose of 20 mg

Time Frame: 12 months

Timeline

  • Last Updated
    March 12, 2025
  • Start Date
    September 7, 2022
  • Today
    June 23, 2025
  • Completion Date ( Estimated )
    January 1, 2026

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