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Trial Title:
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
NCT ID:
NCT05530655
Condition:
Prostate Cancer
Radiation Toxicity
Urinary Complication
Conditions: Official terms:
Prostatic Neoplasms
Lisinopril
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lisinopril Tablets
Description:
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
Arm group label:
Intervention group
Summary:
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wilmot Cancer Institute
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Therese Smudzin
Phone:
585-275-7848
Email:
Therese_Smudzin@urmc.rochester.edu
Start date:
February 20, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Collaborator:
Agency:
Medical College of Wisconsin
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530655
