NCT05530655 · University of Rochester
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Lisinopril Tablets
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
Primary outcome measures
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, New York
Collaborators
Medical College of Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations