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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Janssen Research & Development, LLC Identifier:
First received: May 2, 2012
Last updated: April 8, 2016
Last verified: April 2016
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 Intervention Phase
Prostate Cancer
Drug: Placebo and prednisone
Drug: Abiraterone acetate and prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Time to prostate specific antigen (PSA) progression (TTPP) [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The percentage of people in a study or treatment group who are alive from date of randomization to date of death

  • Time to initiation of cytotoxic chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Date of randomization to date of initiation of chemotherapy

  • Prostate specific antigen (PSA) response rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria

  • Objective response rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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

  • Quality of life (QoL) total score and each subscale score [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Assessed by functional assessment of cancer therapy-prostate (FACT-P)

  • Time to pain progression [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score

  • Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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)

  • Collection of safety data including adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 313
Study Start Date: March 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01591122

Beijing, China
Chengdu, China
Chongqing, China
Guangzhou, China
Hangzhou, China
Jinan, China
Nanjing, China
Shanghai, China
Tianjin, China
Wuhan, China
Kuala Lumpur, Malaysia
Kuala Lumpur N/A, Malaysia
Russian Federation
Arkhangelsk, Russian Federation
Ekaterinburg, Russian Federation
Moscow, Russian Federation
Moscow N/A, Russian Federation
Pyatigorsk, Russian Federation
Rostov-On-Don, 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
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC Identifier: NCT01591122     History of Changes
Other Study ID Numbers: CR100011  ABI-PRO-3002 
Study First Received: May 2, 2012
Last Updated: April 8, 2016
Health Authority: China: Food and Drug Administration
Russia: Ministry of Health and Social Development
Vietnam: Ministry of Health
Malaysia: National Pharmaceutical Control Bureau
Thailand: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Keywords provided by Janssen Research & Development, LLC:
Prostate cancer
Metastatic Castration Resistant Prostate Cancer
Abiraterone acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Abiraterone Acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Steroid Synthesis Inhibitors processed this record on May 26, 2016