Treating patients with metastatic advanced prostate cancer with abiraterone acetate currently not approved in GDL.

Study Objective

A recently completed randomized and controlled study (Study COU-AA-301) demonstrated that treatment with abiraterone acetate, in combination with prednisone or prednisolone, improved survival among men with metastatic advanced prostate cancer, also known as castrate-resistant prostate cancer (CRPC), who have failed docetaxel chemotherapy.
ABIRATERONE ACETATE is provided on a compassionate use basis for treating patients with metastatic advanced prostate cancer and is currently not approved in Luxembourg.

Participation conditions

The inclusion and exclusion criteria used in the Phase 3 clinical study, COU-AA-301 are provided here as a guide to help physicians understand the patient population in which abiraterone acetate use for a Named Patient request can be based on Phase 3 study outcomes.

Eligibility criteria:

• Age ≥ 18 years and male.
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
• Received at least one but no more than two cytotoxic chemotherapy regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel. If a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen.
• Prostate cancer progression as assessed by the physician with one of the following:
  • PSA progression according to Prostate Cancer Working Group 2(PCWG2) criteria.
  • Radiographic progression in soft tissue according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria or bone scans with or without PSA progression.
• Ongoing androgen deprivation with serum testosterone < 50 ng/dL (<2.0 nM).
• Hemoglobin ≥ 9.0 g/dL independent of transfusion.
• Platelet count ≥ 100,000/μL.
• Serum albumin ≥ 3.0 g/dL.
• Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min.
• Serum potassium ≥ 3.5 mmol/L.
• Able to swallow the drug as a whole tablet.

Non eligibility criteria:

• Eligible for another study of ABIRATERONE ACETATE that is open to enrollment.
• Received ABIRATERONE ACETATE in the past, before this Named Patient Program, or was enrolled in trials AA-301 or AA-302.
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
• Abnormal liver functions consisting of any of the following:
  • Serum bilirubin ≥ 1.5 x ULN (except for patients with Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 x ULN.
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg; patients with a history are allowed provided blood pressure is controlled by anti-hypertensive therapy.
• Active or symptomatic viral hepatitis or chronic liver disease.
• History of pituitary or adrenal dysfunction.
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline.
• Known brain metastasis.
• History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of ABIRATERONE ACETATE.
• Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole, ketoconazole) within 4 weeks of cycle1, day 1.
• Current enrolment in an investigational drug or device study or participation in such a study within the last 30 days.
• Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4) Grade of ≤ 1. Chemotherapy-induced alopecia and Grade 2 .peripheral neurotherapy is allowed.
• Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the physician during ABIRATERONE ACETATE treatment and for at least 13 weeks after last administration.
   

Oncologists in Luxembourg