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Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Neoplasms

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Trial Information

Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer

This is an open-label (identity of assigned study drug will be known) early access protocol
(EAP). Approximately 60 participants will be enrolled in this study. Participants will
receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily.
Treatment in 28-day cycles will continue until progression of clinical disease. Study drug
will be provided until the company obtains market authorization and reimbursement in the
participant countries for this indication.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Not have received cytotoxic chemotherapy regimens for metastatic castration-resistant
prostate cancer

- Have prostate cancer progression as assessed by the investigator with
prostate-specific antigen progression according to Prostate Cancer Working Group 2

- Have asymptomatic or mildly symptomatic prostate cancer

- Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)

- Have Eastern Cooperative Oncology Group performance status of <=2

- Laboratory values within protocol-defined parameters

- Adequate liver function according to protocol-defined parameters

- Be able to swallow the study drug whole as a tablet

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Eligible for another study of abiraterone acetate that is open to enrollment

- Has received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or

- Has serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection

- Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood
pressure >=95 mmHg); individuals with a history of hypertension are allowed provided
blood pressure is controlled by anti-hypertensive therapy

- Has active or symptomatic viral hepatitis or chronic liver disease

- Has a history of pituitary or adrenal dysfunction

- Has 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 Class III or IV heart disease or left ventricular ejection
fraction of <50% at baseline

- Has atrial fibrillation or other cardiac arrhythmia

- Has known brain metastasis

- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of
castration-resistant prostate cancer (CRPC)

- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

- Has an active infection or other medical condition that would make
prednisone/prednisolone use contraindicated

- Has had other anticancer therapy including cytotoxic, radionucleotide, and

- Has had prior systemic treatment with an azole drug; diethylstilbestrol; PC-SPES;
spironolactone; and other preparations such as saw palmetto thought to have endocrine
effects on prostate cancer, within 4 weeks of Cycle 1 Day 1

- Is currently enrolled in an investigational drug or device study or has participated
in such a study within 30 days of Day 1

- Has a condition or situation which, in the investigator's opinion, may put the
participant at significant risk, may confound the study results, or may interfere
significantly with participant's participation in the study

- Has 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
principal investigator and sponsor during the study and for 13 weeks after last study
drug administration

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants affected by an adverse event

Outcome Time Frame:

Up to 30 days after the last dose of study medication

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study ID:




Start Date:

April 2013

Completion Date:

September 2014

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Metastatic prostate cancer
  • Metatatic castration resistant prostate cancer
  • Abiraterone acetate
  • Prednisone
  • Prednisolone
  • Early access program
  • Neoplasms
  • Prostatic Neoplasms