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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Radiation Toxicity; Urinary Complication
• Intervention / Treatment: Drug: Lisinopril Tablets

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Therese Smudzin; Phone Number: 585-275-7848; Email: Therese_Smudzin@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • Wilmot Cancer Institute
      • Contact: Therese Smudzin; Phone Number: 585-275-7848; Email: Therese_Smudzin@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Drug: Lisinopril Tablets; This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
No Intervention: Control group; Patients who receive radiation but no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Expanded Prostate Index Composite score	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.	baseline to 12 months
change in the percentage of patients with positive blood test in urine		baseline to 12 months
percentage of participants who achieve a dose of 20 mg		12 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Angiotensin-Converting Enzyme Inhibitors; Lisinopril
• Other Study ID Numbers: STUDY00007510_URGUP23077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No