Lisinopril for the Prevention of Urinary Side Effects Following Radiation Therapy in Patients with Prostate Adenocarcinoma

Inclusion Criteria

• ARM 1: Have a histologically confirmed diagnosis of adenocarcinoma of the prostate
• ARM 1: Candidates for curative-intent external beam radiation (with or without brachytherapy). Radiotherapy may be either primary, adjuvant, or salvage. It should be part of combined treatment with androgen deprivation (ADT)
• ARM 1: Be stage M0 based on the local standard of care assessment(s)
• ARM 1: Be >= 18 years of age
• ARM 1: Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 180 days prior to enrollment
• ARM 1: Have adequate renal function with creatinine clearance > 30 mL/min within 30 days prior to registration
• ARM 1: Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)
• ARM 1: Platelet count >= 100,000/µL independent of transfusion and/or growth factor (within 90 days prior to registration)
• ARM 1: Baseline systolic blood pressure >= 110 mmHg
• ARM 2: Meet all eligibility criteria for arm 1 EXCEPT that they are already taking lisinopril prior to study entry * May be on any dose of lisinopril, for any indication

Exclusion Criteria

• ARM 1: Have received prior pelvic radiotherapy
• ARM 1: Be taking RAS-modifying drug (including lisinopril) within two weeks prior to informed consent
• ARM 1: Have had a prior allergic reaction to any angiotensin-converting enzyme (ACE)-inhibitor
• ARM 1: Have additional medical comorbidity or device that is deemed not suitable for this study, such as angiodema
• ARM 2: Meet all ineligibility criteria for arm 1 EXCEPT that they are already taking lisinopril prior to study entry