177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Exclusion Criteria

• •Pathological finding consistent with small cell or neuroendocrine carcinoma of the prostate
• •Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitor
• •Prior therapy with 177Lu-PSMA 617 therapy. Exception: prior therapy with radium 223 is allowed if last dose was ≥ 6 months from study therapy. Note that other prior radiation therapy (such as external beam radiation therapy or brachytherapy) to prostate or other metastatic sites is allowed.
• •History of adrenal dysfunction
• •Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
• •1. Non-muscle invasive bladder cancer
• •2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured
• •3. Malignancy that is considered cured with minimal risk of recurrence
• •History or current diagnosis of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
• •Current evidence within 3 months of study consent of any of the following: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant arterial or venous thromboembolic events (i.e., pulmonary embolism), or clinically significant ventricular arrhythmias.
• •Presence of sustained uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg). Participants with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by an antihypertensive treatment.
• •Known allergies, hypersensitivity, or intolerance to the excipients of Nira/AA tablets.
• •Current evidence of any medical condition that would make prednisone use contraindicated.
• •Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication
• •Participants who have had the following ≤ 28 days prior to enrollment
• •1. A transfusion (platelets or red blood cells);
• •2. Hematopoietic growth factors;
• •3. Major surgery
• •Participants with known history of human immunodeficiency virus with 1 or more of the following:
• •1. Not receiving highly active antiretroviral therapy or on antiretroviral therapy for less than 4 weeks
• •2. Receiving antiretroviral therapy that may interfere with the study medication
• •3. CD4 (type of white blood cell) count \<350 at screening.
• •4. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
• •5. Human immunodeficiency virus load \>400 copies/mL
• •Known history of active or symptomatic viral hepatitis or chronic liver disease; encephalopathy, ascites or bleeding disorders secondary to hepatic dysfunction.
• •Moderate or severe hepatic impairment (Class B and C per Child-Pugh classification system).