Recruiting
Early Phase 1

Lisinopril

Sponsor:

University of Rochester

Code:

NCT05530655

Conditions

Prostate Cancer

Radiation Toxicity

Urinary Complication

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Lisinopril Tablets

Study Details

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 ID

NCT05530655

Start date

Feb 20, 2024

Status verified date

Jul, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control group

Patients who receive radiation but no intervention

experimental: Intervention group

Interventions

Lisinopril Tablets

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

Primary outcome measure

  • Mean change in Expanded Prostate Index Composite score [ Time Frame: baseline to 12 months ]
  • change in the percentage of patients with positive blood test in urine [ Time Frame: baseline to 12 months ]
  • percentage of participants who achieve a dose of 20 mg [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Therese Smudzin

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

Locations

Wilmot Cancer Institute

Recruiting

Rochester, New York, United States, 14642

Contacts

Therese Smudzin

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

More Information

Sponsor

University of Rochester

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-23.