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Recruiting

NCT Number: NCT05530655

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Therese Smudzin

CONTACT

[email protected]

585-275-7848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lisinopril Tablets

Drug

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

Primary outcomes

  1. Mean change in Expanded Prostate Index Composite score

    Time frame: baseline to 12 months

    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.

  2. change in the percentage of patients with positive blood test in urine

    Time frame: baseline to 12 months

  3. percentage of participants who achieve a dose of 20 mg

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Therese Smudzin

CONTACT

[email protected]

585-275-7848

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 7, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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