Determining the best dose of lisinopril to prevent urinary issues after prostate cancer radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify the optimal dose of lisinopril for men with non-metastatic prostate cancer who are receiving radiation therapy. It will assess the impact of lisinopril on urinary symptoms and evaluate biomarkers associated with these symptoms. Participants will receive lisinopril tablets during their treatment, and their urinary health will be monitored throughout the study. The research is being conducted at the Wilmot Cancer Institute, focusing on improving patient outcomes related to radiation toxicity.

Why it matters

Who can join: the full rules

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 it's running

• Wilmot Cancer Institute
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Therese Smudzin
• Email: Therese_Smudzin@urmc.rochester.edu
• Phone: 585-275-7848

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.