ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide

Exclusion Criteria

• •1. Pathological findings consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.
• •2. Participant has active (new or progressive) brain metastases for whom the treating physician determines that central nervous system (CNS) specific treatment is required immediately or during the first cycle of therapy. Lymph nodes as only sites of metastases.
• •Those with active (new or progressive) brain metastases for whom the treating physician determines that CNS specific treatment is not required immediately or during the first cycle of therapy are eligible for inclusion.
• •3. Visceral (ie, liver or lung) metastases as only sites of metastases.
• •4. Current evidence of any of the following:
• •1. Any of the following within 6 months prior to first dose of apalutamide: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease.
• •2. Gastrointestinal disorder affecting absorption.
• •3. Active infection requiring systemic therapy such as human immunodeficiency virus.
• •4. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
• •5. History of seizure or known condition that has been determined to significantly predispose to seizure per Investigator (including, but not limited to, loss of consciousness within 1 year prior to screening, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
• •6. Participant have known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (please refer to Investigator's Brochure).
• •7. Prior novel hormone therapy or chemotherapy.
• •8. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to enrollment.
• •9. Current or prior treatment with anti-epileptic medications for the treatment of seizures.
• •10. Administration of other investigational therapeutic agents, blood product support, growth factor support or invasive surgical procedure (not including surgical castration) ≤ 28 days prior to the first dose of apalutamide or currently enrolled in an investigational study.
• •11. Any condition or situation that in the opinion of the Investigator, would preclude participation in the study.