Phase I Study to Find the Best Dose of Lisinopril to Prevent Urinary Problems After Radiotherapy for Prostate Cancer in Men

What this Trial Is About

Researchers are studying men with non-metastatic prostate cancer who are receiving radiation treatment to find the preferred dose of lisinopril. The study aims to evaluate how lisinopril affects urinary symptoms and how it influences certain biomarkers related to these symptoms. This phase I trial focuses on prevention of urinary toxicity caused by radiation therapy. Participants will be given lisinopril tablets in escalating doses of 5 mg, 10 mg, and 20 mg once daily. The study includes a control group receiving radiation treatment without any intervention. The trial is randomized and sequential, allowing comparison between the groups to determine the best dose that may prevent urinary side effects after radiotherapy. During the study, participants will be monitored for changes in urinary symptoms using the Expanded Prostate Index Composite score over 12 months. Researchers will also track the percentage of patients with blood detected in urine and the proportion who tolerate the highest dose of 20 mg. The total study duration includes follow-up assessments to measure these outcomes and ensure safety, with the trial completion planned by 2028.

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