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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01591122
First received: May 2, 2012
Last updated: September 15, 2014
Last verified: September 2014

May 2, 2012
September 15, 2014
March 2012
March 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01591122 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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.
  • 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
  • Experimental: Abiraterone acetate and prednisone
    Intervention: Drug: Abiraterone acetate and prednisone
  • Active Comparator: Placebo and prednisone
    Intervention: Drug: Placebo and prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
313
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Malaysia,   Russian Federation,   Thailand
 
NCT01591122
CR100011, ABI-PRO-3002
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP