What is lisinopril studying for prostate cancer?

Lisinopril is being studied to find the best dose to prevent urinary problems caused by radiation therapy in men with prostate cancer. Researchers want to see how lisinopril affects urinary symptoms and related biomarkers during treatment. This study is sponsored by the University of Rochester.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 to 70 with confirmed prostate adenocarcinoma scheduled for external beam radiation may be eligible. Participants must have good kidney, liver, and blood function and not be taking lisinopril or similar drugs recently. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years - 70Years

MALE

ID05530655

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

Led by University of Rochester · Updated on 2026-01-13

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the preferred dose of lisinopril in men with non-metastatic prostate cancer who are undergoing radiation treatment. The study aims to assess how lisinopril affects urinary symptoms and biomarkers related to these symptoms during and after radiation therapy. This is an early phase 1, randomized trial sponsored by the University of Rochester. Participants will either receive radiation therapy alone or radiation combined with lisinopril tablets at escalating doses of 5 mg, 10 mg, or 20 mg taken once daily. The study compares these groups to understand the optimal lisinopril dose for preventing urinary toxicity after radiotherapy. Radiation may be given as primary, adjuvant, or salvage treatment, possibly with androgen deprivation therapy. During the 12-month study, researchers will monitor urinary symptoms using the Expanded Prostate Index Composite score and measure the presence of blood in urine. They will also track how many participants reach the 20 mg lisinopril dose. Participants will undergo assessments including blood tests and evaluations of kidney, liver, and blood function. The study includes follow-up to evaluate the safety and effects of lisinopril on urinary health after radiation treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

MALE

Eligibility Criteria

You may qualify if you...

Have confirmed adenocarcinoma of the prostate and are candidates for curative external beam radiation therapy
Be stage M0 based on standard staging imaging
Be able to read English
Have psychological and general health ability to complete study and follow-up
Be between 18 and 70 years old
Have ECOG performance status of 0 to 2 within 180 days before enrollment
Have adequate renal function with creatinine clearance greater than 30 mL/min within 30 days before registration
Have adequate blood and liver function within 90 days before registration, including hemoglobin ≥9.0 g/dL and platelet count ≥100,000/µL
Have baseline systolic blood pressure above 130

You will not qualify if you...

Have had prior pelvic radiotherapy
Are taking lisinopril or other renin-angiotensin system modifying drugs within two months before registration
Have had an allergic reaction to lisinopril

Research Team

Therese Smudzin

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