Determining the best dose of lisinopril to prevent urinary issues after prostate cancer radiotherapy
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
This study is testing the best dose of lisinopril to see if it can help men with prostate cancer avoid urinary problems after radiation treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05530655 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 70 with non-metastatic adenocarcinoma of the prostate who are eligible for curative-intent radiation therapy.
Not a fit: Patients with metastatic prostate cancer or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce urinary complications in prostate cancer patients undergoing radiotherapy.
How similar studies have performed: While similar studies have explored the use of lisinopril in various contexts, this specific approach to urinary toxicity prevention in prostate cancer radiotherapy is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.