NCT05530655 A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
| NCT ID | NCT05530655 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Rochester |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-02-20 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05530655 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05530655 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05530655 currently recruiting?
Yes, NCT05530655 is actively recruiting participants. Contact the research team at Therese_Smudzin@urmc.rochester.edu for enrollment information.
Where is the NCT05530655 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05530655 clinical trial?
NCT05530655 is sponsored by University of Rochester. The trial plans to enroll 30 participants.
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