RECRUITING

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

Conditions

Prostate Cancer Radiation Toxicity Urinary Complication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-02-20

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05530655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Therese Smudzin

CONTACT

585-275-7848

Therese_Smudzin@urmc.rochester.edu

Study Locations (Sites)

Wilmot Cancer Institute

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-02-20

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer
Radiation Toxicity
Urinary Complication