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Lisinopril for Preventing Urinary Toxicity After Prostate Cancer Radiotherapy

This study is testing different doses of Lisinopril tablets (5 mg, 10 mg, or 20 mg once daily) to see which dose is best for preventing urinary problems after radiation treatment for prostate cancer. You may be able to join if you are a man between 18 and 70 years old with prostate cancer that hasn't spread and you are receiving radiation at Wilmot Cancer Institute. The study will look at how your urinary symptoms change over 12 months and the percentage of participants who can take the 20 mg dose. The current recruitment status is unclear.

Study design
This is a dose escalation study with 30 planned participants. It aims to find the preferred dose of Lisinopril.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study.

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NCT05530655

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

Recruiting
EARLY_PHASE1Ages 18–70InterventionalPrevention
University of Rochester
~30 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Lisinopril Tablets

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in Expanded Prostate Index Composite score
Measured over baseline to 12 months
+2 more outcomes measured

Conditions

Prostate Cancer
Radiation Toxicity
Urinary Complication

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Therese Smudzin
[email protected]
585-275-7848
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean change in Expanded Prostate Index Composite scorebaseline to 12 months

    Patient reported outcomes capturing urinary symptoms will be collected using the Expanded Prostate Index Composite (EPIC) patient reported outcome questionnaire prior to radiation on the first day of treatment, weekly during radiation, and approximately 1 month, 3 months, 6 months, and 12 months after radiation. The EPIC bladder domain score will quantify patient reported urinary symptoms. The EPIC bladder domain consists of 12 items each scored on a Likert scale with an overall score transformed to a 0-100 scale. A higher score indicates worse outcome.

  • change in the percentage of patients with positive blood test in urinebaseline to 12 months
  • percentage of participants who achieve a dose of 20 mg12 months