TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer

Inclusion Criteria

• Written informed consent obtained prior to any study-related procedure being performed
• Male patients at least 18 years of age or older at time of consent
• Pathologically confirmed adenocarcinoma of the prostate
• Ongoing therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist (unless patient has already had a bilateral orchiectomy) AND serum testosterone level 10 mg prednisone daily. Patients who have discontinued or reduced dosing to the equivalent of ≤ 10 mg prednisone daily within 14 days prior to the start of study drug are eligible
• Known, symptomatic metastases to the brain or central nervous system involvement (patients with asymptomatic and neurologically stable disease for the past 4 weeks will be permitted)
• History of adrenal gland dysfunction defined as requiring treatment for adrenal insufficiency
• History of other malignancy within the previous 2 years (no longer being actively treated), with the exceptions of basal cell carcinoma, nonmuscle invasive bladder cancer that has been treated and is under surveillance, or other in-situ cancers with a low likelihood of recurrence
• Major surgery within 4 weeks prior to the start of study drug
• Known gastrointestinal disease or condition that could impair absorption inclusive of gastrocolic fistula, gastroenterostomy, biliary obstruction, cirrhosis, chronic pancreatitis or pancreatic cancer, cystic fibrosis, lactate deficiency, amyloidosis, celiac disease, Crohn's disease, radiation enteritis, intestinal resection, and history of bariatric surgery
• Known history of human immunodeficiency virus or seropositive test for hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) (note: HCV patients with undetectable viral load will be eligible)
• Poorly controlled diabetes, defined as hemoglobin A1c (HbA1c) > 8% within the past 12 months
• Uncontrolled hypertension at screening
• History of New York Heart Association class III or IV heart failure
• Serious concurrent illness, including psychiatric illness, that could interfere with study participation
• Receipt of another investigational agent within 4 weeks or 5 x the treatment half-life, whichever is longer, of treatment start.
• Known hypersensitivity or allergy to abiraterone acetate, prednisone or any excipients in the study drugs
• In the opinion of the investigator, participation in the trial would prevent the patient from receiving local standard-of-care treatment for metastatic prostate cancer, if clinically indicated, after completion of the trial
• Other condition which, in the opinion of the Investigator, would preclude participation in this trial.