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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530655
• Other study ID #: STUDY00007510_URGUP23077
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 20, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: University of Rochester
• Contact: Therese Smudzin
• Phone: 585-275-7848
• Email: Therese_Smudzin[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiation Toxicity

Intervention

Drug:
• Lisinopril Tablets
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.

Locations

Country	Name	City	State
United States	Wilmot Cancer Institute	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in the percentage of patients with positive blood test in urine		baseline to 12 months
Primary	percentage of participants who achieve a dose of 20 mg		12 months