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A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT05530655•University of Rochester

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

MALE

Healthy Volunteers

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
+1 more criteria

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

Locations (1)

Wilmot Cancer Institute

Rochester, New York, United States

Key Dates

Start Date

February 20, 2024

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Prostate CancerRadiation ToxicityUrinary Complication

Interventions

Lisinopril Tablets

DRUG

Contacts

Therese Smudzin

CONTACT

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

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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