Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

May 24, 2018 updated by: Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), 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 in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.

Study Type

Interventional

Enrollment (Actual)

1088

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Footscray, Australia
      • Frankston, Australia
      • Garran, Australia
      • Geelong, Australia
      • Heidelberg, Australia
      • Herston, Australia
      • Hornsby, Australia
      • Kogarah, Australia
      • Kurralta Park, Australia
      • Lismore, Australia
      • Liverpool, Australia
      • Malvern, Australia
      • Parkville, Australia
      • Perth, Australia
      • South Brisbane, Australia
      • Southport, Australia
      • Subiaco, Australia
  • Belgium
      • Aalst, Belgium
      • Antwerpen, Belgium
      • Gent, Belgium
      • Hasselt, Belgium
      • Leuven Belgie, Belgium
      • Roeselare, Belgium
  • Canada
      • London, Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Caen, France
      • Clichy, France
      • Dijon Cedex, France
      • La Roche Sur Yon, France
      • Lyon, France
      • Lyon Cedex 03, France
      • Montpellier, France
      • Paris Cedex 15, France
      • Tours, Cedex 9, France
      • Villejuif, France
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Braunschweig, Germany
      • Dresden, Germany
      • Düsseldorf, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Homburg, Germany
      • Kempen, Germany
      • Leipzig, Germany
      • Muenchen, Germany
      • Münster, Germany
      • Wuppertal, Germany
  • Greece
      • Athens, Greece
      • Larisa, Greece
  • Netherlands
      • Amsterdam, Netherlands
      • Heerlen, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
  • Spain
      • Barcelona, Spain
      • Coruña, Spain
      • Madrid, Spain
      • Oviedo, Spain
      • Santander N/A, Spain
      • Santiago De Compostela, Spain
  • Sweden
      • Göteborg, Sweden
      • Malmö N/A, Sweden
      • Stockholm, Sweden
      • Uppsala, Sweden
      • Växjö, Sweden
  • United Kingdom
      • Birmingham, United Kingdom
      • Cambridge, United Kingdom
      • Glasgow, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Oxford, United Kingdom
      • Sutton, United Kingdom
      • Whitchurch, United Kingdom
      • Wirral, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Bellflower, California, United States
      • Los Angeles, California, United States
      • Marina Del Rey, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Stanford, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Boca Raton, Florida, United States
      • Fort Myers, Florida, United States
      • Gainesville, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Dearborn, Michigan, United States
    • Minnesota
      • Saint Louis Park, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • East Syracuse, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cleveland, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Metastatic castration-resistant prostate cancer (CRPC)
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status of either 0 or 1
  • Medical or surgical castration with testosterone less than 50 ng/dL
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Prior cytotoxic chemotherapy or biologic therapy for CRPC
  • Prior ketoconazole for prostate cancer
  • Known brain metastasis or visceral organ metastasis
  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo + prednisone
Placebo plus prednisone
Drug: Placebo
4 placebo tablets per day taken orally.
Drug: Prednisone
5 mg tablet orally twice daily.
Experimental: Abiraterone + prednisone
Abiraterone acetate plus prednisone
Drug: Prednisone
5 mg tablet orally twice daily.
Drug: Abiraterone acetate
1000 mg per day (4 x 250-mg tablets) taken orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization (Day 1) up to end of study (Month 60)
Overall survival is defined as the time from randomization to date of death from any cause.
From randomization (Day 1) up to end of study (Month 60)
Radiographic Progression-free Survival (rPFS)
Time Frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Opiate Use for Prostate Cancer Pain
Time Frame: From randomization (Day 1) up to first opiate use or end of study (Month 60)
The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
From randomization (Day 1) up to first opiate use or end of study (Month 60)
Time to Initiation of Cytotoxic Chemotherapy
Time Frame: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
Time Frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
Number of Participants With Treatment Emergent Adverse Events
Time Frame: From first dose of study drug up to 30 days after the last dose of study drug
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
From first dose of study drug up to 30 days after the last dose of study drug
Mean Plasma Concentrations of Abiraterone
Time Frame: Up to Cycle 5, Day 1
Up to Cycle 5, Day 1
Maximum Plasma Concentrations of Abiraterone
Time Frame: Up to Cycle 5, Day 1
Up to Cycle 5, Day 1
Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
Time Frame: Up to Cycle 5, Day 1
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Up to Cycle 5, Day 1
Elimination Half-Life (t1/2)
Time Frame: Up to Cycle 5, Day 1
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Up to Cycle 5, Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2009

Primary Completion (Actual)

March 31, 2014

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

April 18, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016927
  • COU-AA-302 (Other Identifier: Janssen Research & Development, LLC)
  • 2008-008004-41 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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