Wilmot Cancer Institute
Rochester, New York, 14642, United States
Location status: Recruiting
NCT Number: NCT05530655
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.
Interested in participating?
Request Info18 year–70 year
Male
Interventional
Early Phase 1
Rochester, New York, 14642, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
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.
Time frame: baseline to 12 months
Time frame: 12 months
Contact information is provided by the study sponsor or research team.
University of Rochester
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04075305
Bladder Cancer, Bladder Neoplasm
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT03920033
Biochemical Recurrence, Dose Escalation
Seoul, South Korea
View Trial DetailsNCT00769223
Genital Diseases, Genital Diseases, Male
San Francisco, California, United States
View Trial DetailsNCT01856855
Genital Diseases, Genital Diseases, Male
Birmingham, Alabama, United States
View Trial Details