RecruitingEarly Phase 1NCT05530655

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

A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer


Sponsor

University of Rochester

Enrollment

30 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is finding the best dose of lisinopril — a blood pressure medication — to prevent urinary side effects (like urgency, frequency, or pain) caused by radiation therapy for prostate cancer. **You may be eligible if...** - You are 18 to under 70 years old with confirmed prostate adenocarcinoma - You are scheduled to receive external beam radiation therapy to the prostate (as primary, adjuvant, or salvage treatment), possibly with hormone therapy - Your cancer has not spread to distant organs (stage M0) - You can read English - Your kidney function, blood counts, and liver function are adequate - Your resting systolic blood pressure is above 130 mmHg **You may NOT be eligible if...** - You have had prior pelvic radiation therapy - You are currently taking lisinopril or a similar blood pressure medication (ACE inhibitor or ARB) within the last 2 months - You have had a prior allergic reaction to lisinopril Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLisinopril Tablets

This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.


Locations(1)

Wilmot Cancer Institute

Rochester, New York, United States

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NCT05530655


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