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A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

Phase 3
18 Years
Open (Enrolling)
Prostate Neoplasms

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Trial Information

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

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 designed to determine if newly diagnosed (within previous 3
months) patients with mHNPC who have high-risk prognostic factors will benefit from the
addition of abiraterone acetate and low-dose prednisone to ADT (LHRH agonists or surgical
castration). Approximately 1270 patients will be enrolled in this study. Patients will be
stratified by presence of visceral disease and Eastern Cooperative Oncology Group
performance grade prior to randomization. The study protocol consists of the following
phases: screening, double-blind treatment, and follow-up phase of up to 60 months to monitor
survival status and subsequent prostate cancer therapy. Patients will be randomized in a 1:1
ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg
daily plus ADT) or the control group (ADT plus placebos). Treatment in 28-day cycles will
continue until disease progression or the occurrence of unacceptable toxicity. Patients will
be monitored for efficacy and safety throughout the study. Two interim analyses and a final
analysis are planned for this study. In the event of a positive study result at either of
the interim analyses or at the time of the final analysis, all participants will have the
opportunity to enroll in an open-label extension phase that will allow participants to
receive active drug (abiraterone acetate plus prednisone) for up to 3 years.

Inclusion Criteria:

- Newly diagnosed metastatic prostate cancer within 3 months prior to randomization
with histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Distant metastatic disease documented by positive bone scan or metastatic lesions on
computed tomography (CT) or magnetic resonance imaging (MRI) scan

- At least 2 of the following high-risk prognostic factors: Gleason score of >=8;
presence of 3 or more lesions on bone scan; presence of measurable visceral
(excluding lymph node disease) metastasis on CT or MRI scan

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2

- Adequate hematologic, hepatic, and renal function

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Active infection or other medical condition that would make prednisone use

- Any chronic medical condition requiring a higher systemic dose of corticosteroid than
5 mg prednisone per day

- Pathological finding consistent with small cell carcinoma of the prostate

- Known brain metastasis

- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate
cancer (the following exception are permitted): up to 3 months of androgen
deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or
orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; patients
may have one course of palliative radiation or surgical therapy to treat symptoms
resulting from metastatic disease if it was administered at least 28 days prior to
Cycle 1 Day 1); all adverse events associated with these procedures must be resolved
at least to Grade 1 by Cycle 1 Day 1

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

- Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding
disorders secondary to hepatic dysfunction

- History of adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events or history of cardiac failure in the past 6 months, severe
or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease

- Atrial fibrillation or other cardiac arrhythmia requiring pharmacotherapy

- Other malignancy (within 5 years), except non-melanoma skin cancer

- Administration of an investigational therapeutic or invasive surgical procedure (not
including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled
in an investigational study

- Any condition or situation which, in the opinion of the investigator, would put the
patient at risk, may confound study results, or interfere with the patient's
participation in this study

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:

Overall survival

Outcome Time Frame:

Up to the time of death from any cause (up to Month 60)

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

July 2018

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Metastatic prostate cancer
  • Abiraterone acetate
  • Prednisone
  • Androgen deprivation therapy
  • Neoplasms
  • Prostatic Neoplasms