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

NCT ID: NCT05530655

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2028-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Patients who receive radiation but no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Group Type: EXPERIMENTAL

Lisinopril Tablets

Intervention Type: DRUG

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

Interventions

Lisinopril Tablets

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Hong Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wilmot Cancer Institute

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Therese Smudzin

Role: CONTACT

Therese_Smudzin@urmc.rochester.edu

585-275-7848

Facility Contacts

Therese Smudzin

Role: primary

Therese_Smudzin@urmc.rochester.edu

585-275-7848

Other Identifiers

STUDY00007510_URGUP23077

Identifier Type: -

Identifier Source: org_study_id