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

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

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
Brief Summary

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).

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.

Overall Status Completed
Start Date April 28, 2009
Completion Date May 25, 2017
Primary Completion Date March 31, 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall Survival From randomization (Day 1) up to end of study (Month 60)
Radiographic Progression-free Survival (rPFS) From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Secondary Outcome
Measure Time Frame
Time to Opiate Use for Prostate Cancer Pain From randomization (Day 1) up to first opiate use or end of study (Month 60)
Time to Initiation of Cytotoxic Chemotherapy 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 From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Time to Prostate-specific Antigen (PSA) Progression From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
Number of Participants With Treatment Emergent Adverse Events From first dose of study drug up to 30 days after the last dose of study drug
Mean Plasma Concentrations of Abiraterone Up to Cycle 5, Day 1
Maximum Plasma Concentrations of Abiraterone 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]) Up to Cycle 5, Day 1
Elimination Half-Life (t1/2) Up to Cycle 5, Day 1
Enrollment 1088
Condition
Intervention

Intervention Type: Drug

Intervention Name: Abiraterone acetate

Description: 1000 mg per day (4 x 250-mg tablets) taken orally.

Arm Group Label: Abiraterone + prednisone

Intervention Type: Drug

Intervention Name: Placebo

Description: 4 placebo tablets per day taken orally.

Arm Group Label: Placebo + prednisone

Intervention Type: Drug

Intervention Name: Prednisone

Description: 5 mg tablet orally twice daily.

Eligibility

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Location
Facility:
| Birmingham, Alabama, United States
| Tucson, Arizona, United States
| 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
| Aurora, Colorado, United States
| New Haven, Connecticut, United States
| Boca Raton, Florida, United States
| Fort Myers, Florida, United States
| Gainesville, Florida, United States
| Atlanta, Georgia, United States
| Honolulu, Hawaii, United States
| Kansas City, Kansas, United States
| Metairie, Louisiana, United States
| New Orleans, Louisiana, United States
| Baltimore, Maryland, United States
| Boston, Massachusetts, United States
| Dearborn, Michigan, United States
| Saint Louis Park, Minnesota, United States
| Saint Louis, Missouri, United States
| Billings, Montana, United States
| Omaha, Nebraska, United States
| Las Vegas, Nevada, United States
| East Syracuse, New York, United States
| New Hyde Park, New York, United States
| New York, New York, United States
| Syracuse, New York, United States
| Durham, North Carolina, United States
| Raleigh, North Carolina, United States
| Canton, Ohio, United States
| Cleveland, Ohio, United States
| Portland, Oregon, United States
| Philadelphia, Pennsylvania, United States
| Pittsburgh, Pennsylvania, United States
| Columbia, South Carolina, United States
| Myrtle Beach, South Carolina, United States
| Chattanooga, Tennessee, United States
| Nashville, Tennessee, United States
| Dallas, Texas, United States
| Houston, Texas, United States
| San Antonio, Texas, United States
| Norfolk, Virginia, United States
| Seattle, Washington, United States
| Madison, Wisconsin, United States
| 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
| Aalst, Belgium
| Antwerpen, Belgium
| Gent, Belgium
| Hasselt, Belgium
| Leuven Belgie, Belgium
| Roeselare, Belgium
| Calgary, Alberta, Canada
| Edmonton, Alberta, Canada
| Kelowna, British Columbia, Canada
| Vancouver, British Columbia, Canada
| Victoria, British Columbia, Canada
| Hamilton, Ontario, Canada
| London, Ontario, Canada
| Toronto, Ontario, Canada
| Montreal, Quebec, Canada
| London, Canada
| Quebec, Canada
| Caen, France
| Clichy, France
| Dijon Cedex, France
| La Roche Sur Yon, France
| Lyon Cedex 03, France
| Lyon, France
| Montpellier, France
| Paris Cedex 15, France
| Tours, Cedex 9, France
| Villejuif, France
| 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
| Athens, Greece
| Larisa, Greece
| Amsterdam, Netherlands
| Heerlen, Netherlands
| Nijmegen, Netherlands
| Rotterdam, Netherlands
| Barcelona, Spain
| Coruña, Spain
| Madrid, Spain
| Oviedo, Spain
| Santander N/A, Spain
| Santiago De Compostela, Spain
| Göteborg, Sweden
| Malmö N/A, Sweden
| Stockholm, Sweden
| Uppsala, Sweden
| Växjö, Sweden
| 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
Location Countries

Australia

Belgium

Canada

France

Germany

Greece

Netherlands

Spain

Sweden

United Kingdom

United States

Verification Date

May 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo + prednisone

Type: Placebo Comparator

Description: Placebo plus prednisone

Label: Abiraterone + prednisone

Type: Experimental

Description: Abiraterone acetate plus prednisone

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov