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

Last updated: March 7, 2025
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Lisinopril Tablets

Clinical Study ID

NCT05530655
STUDY00007510_URGUP23077
  • Ages 18-70
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates forcurative-intent external beam radiation (with or without androgen deprivationtherapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology.Radiotherapy may be either primary, adjuvant or salvage. It may be part of combinedtreatment 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 thestudy 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 daysprior to registration

  • Have hematologic and hepatic function deemed adequate for planned treatment by thetreating 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

Exclusion Criteria:

  • Have received prior pelvic radiotherapy

  • Be taking lisinopril or other RAS modifying drug within two months prior toregistration

  • Have had a prior allergic reaction to lisinopril

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Lisinopril Tablets
Phase: 1
Study Start date:
February 20, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • Wilmot Cancer Institute

    Rochester, New York 14642
    United States

    Active - Recruiting

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