A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lisinopril Tablets.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Radiation Toxicity, Urinary Complication. Basic parameters: 18 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wilmot Cancer Institute — Rochester
Identifiers
NCT: NCT05530655 · STUDY00007510_URGUP23077