Actively Recruiting
A Phase I Study to Determine the Preferred Dose of Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Led by University of Rochester · Updated on 2026-01-13
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
M
Medical College of Wisconsin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the preferred dose of lisinopril in men with non-metastatic prostate cancer who are undergoing radiation treatment. The study aims to assess how lisinopril affects urinary symptoms and biomarkers related to these symptoms during and after radiation therapy. This is an early phase 1, randomized trial sponsored by the University of Rochester. Participants will either receive radiation therapy alone or radiation combined with lisinopril tablets at escalating doses of 5 mg, 10 mg, or 20 mg taken once daily. The study compares these groups to understand the optimal lisinopril dose for preventing urinary toxicity after radiotherapy. Radiation may be given as primary, adjuvant, or salvage treatment, possibly with androgen deprivation therapy. During the 12-month study, researchers will monitor urinary symptoms using the Expanded Prostate Index Composite score and measure the presence of blood in urine. They will also track how many participants reach the 20 mg lisinopril dose. Participants will undergo assessments including blood tests and evaluations of kidney, liver, and blood function. The study includes follow-up to evaluate the safety and effects of lisinopril on urinary health after radiation treatment.
CONDITIONS
Brief Title
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed adenocarcinoma of the prostate and are candidates for curative external beam radiation therapy
- Be stage M0 based on standard staging imaging
- Be able to read English
- Have psychological and general health ability to complete study and follow-up
- Be between 18 and 70 years old
- Have ECOG performance status of 0 to 2 within 180 days before enrollment
- Have adequate renal function with creatinine clearance greater than 30 mL/min within 30 days before registration
- Have adequate blood and liver function within 90 days before registration, including hemoglobin ≥9.0 g/dL and platelet count ≥100,000/µL
- Have baseline systolic blood pressure above 130
You will not qualify if you...
- Have had prior pelvic radiotherapy
- Are taking lisinopril or other renin-angiotensin system modifying drugs within two months before registration
- Have had an allergic reaction to lisinopril
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive Lisinopril tablets at escalating doses of 5 mg, 10 mg, or 20 mg once a day during radiotherapy to prevent urinary toxicity.
Regular visits scheduled during radiotherapy and follow-up
Duration - Up to 12 months
Participants are monitored for changes in urinary toxicity and prostate health after treatment ends.
Visits at baseline and periodically up to 12 months
Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
T
Therese Smudzin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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