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Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01591122
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : January 21, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Placebo and prednisone Drug: Abiraterone acetate and prednisone Phase 3

Detailed Description:
This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : March 27, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Abiraterone acetate and prednisone Drug: Abiraterone acetate and prednisone
Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily

Active Comparator: Placebo and prednisone Drug: Placebo and prednisone
Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.

Primary Outcome Measures :
  1. Time to prostate specific antigen (PSA) progression (TTPP) [ Time Frame: 14 months ]
    Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    The percentage of people in a study or treatment group who are alive from date of randomization to date of death

  2. Time to initiation of cytotoxic chemotherapy [ Time Frame: 5 years ]
    Date of randomization to date of initiation of chemotherapy

  3. Prostate specific antigen (PSA) response rate [ Time Frame: 14 months ]
    Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria

  4. Objective response rate [ Time Frame: 14 months ]
    Measurable disease based on modified response evaluation criteria in solid tumors (RECIST) criteria and baseline lymph node size must be 2.0 cm to be considered target or evaluable lesion for RECIST criteria

  5. Quality of life (QoL) total score and each subscale score [ Time Frame: 14 months ]
    Assessed by functional assessment of cancer therapy-prostate (FACT-P)

  6. Time to pain progression [ Time Frame: 14 months ]
    Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score

  7. Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination [ Time Frame: 14 months ]
    ECOG performance status score 0 (Fully active, able to carry on all pre-disease performance without restriction) versus 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, eg, light housework, office work)

  8. Collection of safety data including adverse events [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
  • Prostate cancer progression documented by PSA progression or radiographic progression
  • Asymptomatic or mildly symptomatic from prostate cancer
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status score of 0 or 1
  • If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
  • If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
  • If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
  • Life expectancy of at least 6 months

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 small cell carcinoma of the prostate
  • Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
  • Radiation or radionuclide therapy for treatment of mCRPC
  • Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
  • History of pituitary or adrenal dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01591122

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Beijing, China
Chengdu, China
Chongqing, China
Guangzhou, China
Hangzhou, China
Jinan, China
Nanjing, China
Shanghai, China
Tianjin, China
Wuhan, China
Kuala Lumpur N/a, Malaysia
Kuala Lumpur, Malaysia
Russian Federation
Arkhangelsk, Russian Federation
Ekaterinburg, Russian Federation
Moscow N/a, Russian Federation
Moscow, Russian Federation
Pyatigorsk, Russian Federation
Rostov-on-Don, Russian Federation
Sochi, Russian Federation
St.-Petersburg, Russian Federation
Stavropol, Russian Federation
Ufa, Russian Federation
Yoshkar-Ola, Russian Federation
Bangkok, Thailand
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT01591122    
Other Study ID Numbers: CR100011
ABI-PRO-3002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Keywords provided by Janssen Research & Development, LLC:
Prostate cancer
Metastatic Castration Resistant Prostate Cancer
Abiraterone acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors