NCT05530655RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 1 Sept 2022
- Start date
- 20 Feb 2024
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- University of Rochester
- Diseases
- Prostate cancer
- NCT number
- NCT05530655
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 20 Feb 2024 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wilmot Cancer Institute Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.