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

NCT05530655 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00007510_URGUP23077
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Radiation Toxicity; Urinary Complication

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control group

NO INTERVENTION

Patients who receive radiation but no intervention

Intervention group

EXPERIMENTAL

Drug: Lisinopril Tablets

Interventions

Lisinopril Tablets DRUG

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Medical College of Wisconsin: collaborator

Study Sites (1)

Wilmot Cancer Institute

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Therese Smudzin

CONTACT

585-275-7848; Therese_Smudzin@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 7, 2022
• Study Start: February 20, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)