Could a common blood pressure pill shield the bladder from radiation damage?

NCT ID NCT05530655

Prevention Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This early-phase study is testing whether lisinopril, a widely used blood pressure drug, can prevent urinary side effects in men receiving radiation for prostate cancer. Thirty men with non-metastatic prostate cancer will take one of three daily doses (5, 10, or 20 mg) during their radiation treatment. Researchers will track urinary symptoms and biomarkers to find the safest and most promising dose for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: lisinopril (an ACE inhibitor, a blood pressure drug)
What this could lead to: If it works, this could point toward a simple, low-cost way to prevent urinary problems after prostate radiation.
What could go wrong: This is a very early, small study (30 men) testing only dose safety and tolerability. It is not designed to prove effectiveness, and the drug may not reduce urinary side effects at all.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer radiation injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer Radiation toxicity Urinary complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a common blood pressure pill shield the bladder from radiation damage?

What the study statuses mean