Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With 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:
NCT00887198
First received: April 18, 2009
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone acetate
Drug: Placebo
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 (CB7630) 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:
  • Overall Survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Radiographic progression-free survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to opiate use for cancer pain [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to initiation of cytotoxic chemotherapy [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to deterioration in Eastern Cooperative Oncology Group performance score by >=1 point [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to prostate-specific antigen progression based on Prostate Cancer Working Group 2 criteria [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Mean plasma concentrations of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Time to reach the maximum plasma concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Elimination half-life [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]

Enrollment: 1088
Study Start Date: April 2009
Estimated Study Completion Date: May 2017
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Abiraterone acetate
1000 mg per day (4 x 250-mg tablets) taken orally.
Drug: Prednisone
5 mg tablet orally twice daily.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00887198

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
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
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Boca Raton, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Louisiana
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Dearborn, Michigan, United States
United States, Minnesota
Saint Louis Park, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
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
United States, North Carolina
Durham, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Virginia Beach, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
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, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Kelowna, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada
London, Canada
Quebec, Canada
Vancouver, Canada
France
Caen, France
Clichy, France
Dijon, France
La Roche Sur Yon, France
Lyon, France
Lyon Cedex 03, France
Montpellier, France
Paris, 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
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided by Janssen Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00887198     History of Changes
Other Study ID Numbers: CR016927, COU-AA-302, 2008-008004-41
Study First Received: April 18, 2009
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Prostate cancer
Abiraterone acetate
CB7630
CRPC
Metastatic castration-resistant prostate cancer
hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014