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A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Phase 3
18 Years
Open (Enrolling)
Prostate Neoplasms

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Trial Information

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

This is a randomized (the treatment group is assigned by chance), double-blind (neither
physician nor patient knows the treatment that the patient receives) placebo (an inactive
substance that is compared with a drug to test whether the drug has a real effect in a
clinical trial)-controlled study with a randomization allocation ratio of 2:1 between the
abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group
(placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in
the placebo group) medically or surgically castrated male patients with mCRPC who have
failed docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The
study protocol includes the following phases: screening (within 28 days prior to
randomization on Cycle 1 Day 1), double-blind treatment (28-day cycles until
protocol-defined disease progression or unacceptable toxicity), and survival follow-up (up
to Month 60). During the follow-up phase, patients with disease progression will be provided
open-label (identity of assigned study drug will be known) extension treatment with
abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo will be taken orally (by
mouth) once daily plus prednisone 5 mg tablet orally twice daily. Efficacy and safety will
be monitored throughout the study.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate except
neuroendocrine carcinoma including small cell carcinoma

- Disease progressed on or after prior docetaxel-containing chemotherapy

- Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant
prostate cancer, at least 1 of which contains docetaxel

- Documented prostate cancer progression as documented by prostate specific antigen
progression according to Prostate Specific Antigen Working Group criteria or
radiographic progression in soft tissue or bone

- Surgically or medically castrated, with serum testosterone level <50 ng/dL (1.7

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

- Protocol-defined laboratory values

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Active infection or other medical condition that would make prednisone
(corticosteroid) use contraindicated

- Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg
prednisone twice daily

- Pathological finding consistent with neuroendocrine carcinoma of prostate including
small cell carcinoma

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

- Active or symptomatic viral hepatitis or chronic liver disease, have a known
infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C

- 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 Class III or IV heart disease or cardiac ejection fraction
measurement of <50% at baseline

- Atrial fibrillation, or other cardiac arrhythmia requiring therapy

- Other malignancy within past 3 years (except basal or nonmetastatic squamous cell
carcinoma of the skin)

- Known brain metastasis

- Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or
investigational agent(s) targeting the androgen receptor for metastatic prostate

- Prior therapy with ketoconazole for prostate cancer

- Surgery or local prostatic intervention within 30 days of the first dose

- Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of
palliative radiotherapy within 14 days of administration of Cycle 1 Day 1

- Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not
resolved to a National Cancer Institute-Common Terminology Criteria for Adverse
Events grade of <=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy
is allowed)

- Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of Cycle 1 Day 1

- Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks
(bicalutamide or nilutamide) prior to Cycle 1 Day 1

- Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4
weeks prior to Cycle 1 Day 1

- Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its

- Has contraindications to the use of prednisone per local prescribing information

- Has any condition that, in the opinion of the investigator, would make participation
not be in the best interest (eg, compromise the well-being) of the patient or that
could prevent, limit, or confound the protocol-specified assessments

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to prostate specific antigen (PSA) progression (TTPP)

Outcome Time Frame:

From randomization to the time of PSA progression (up to Month 27)

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2015

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Metastatic castration resistant prostate cancer
  • Abiraterone acetate
  • JNJ-212082
  • Neoplasms
  • Prostatic Neoplasms