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

Early Phase 1

Recruiting

• Conditions: Prostate Cancer; Radiation Toxicity; Urinary Complication
• Interventions: Drug: Lisinopril Tablets

• Registration Number: NCT05530655
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-07
• Study Start: 2024-02-20
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	Lisinopril Tablets	-

Primary Outcome Measures

Name	Time	Method
percentage of participants who achieve a dose of 20 mg	12 months
Mean change in Expanded Prostate Index Composite score	baseline 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 urine	baseline to 12 months

Trial Locations

Locations (1)

Wilmot Cancer Institute; 🇺🇸 Rochester, New York, United States