Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

March 23, 2017 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CRPC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

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
      • Bedford Park, Australia
      • Box Hill, Australia
      • Camperdown, Australia
      • Footscray, Australia
      • Garran, Australia
      • Geelong, Australia
      • Heidelberg, Australia
      • Herston, Australia
      • Hobart, Australia
      • Kogarah, Australia
      • Kurralta Park, Australia
      • Liverpool, Australia
      • Nedlands, Australia
      • Port Macquarie, Australia
      • Randwick, Australia
      • South Brisbane, Australia
      • Southport Qld, Australia
      • Subiaco, Australia
      • Sydney, Australia
      • Tamworth, Australia
      • Wahroonga, Australia
      • Westmead, Australia
      • Wodonga, Australia
      • Woolloongabba, Australia
  • Brazil
      • Belo Horizonte, Brazil
      • Curitiba, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Rio De Janeiro, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Canada
      • Calgary, Canada
      • London, Canada
      • N/a N/a, Canada
      • Quebec, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • Colombia
      • Bogota, Colombia
      • Floridablanca, Colombia
      • Medellin, Colombia
      • Monteria, Colombia
      • Pereira, Colombia
      • Valledupar, Colombia
  • Croatia
      • Split, Croatia
      • Zagreb, Croatia
  • Czech Republic
      • Brno, Czech Republic
      • Hradec Kralove, Czech Republic
      • Olomouc, Czech Republic
      • Praha 2, Czech Republic
      • Usti Nad Labem, Czech Republic
  • Denmark
      • Aarhus, Denmark
      • Copenhagen Ø, Denmark
      • Köpenhamn Ö, Denmark
  • Greece
      • Athens, Greece
      • Athens Attica, Greece
      • Crete, Greece
      • Larisa, Greece
      • Patra, Greece
      • Thessalonikis, Greece
  • Hong Kong
      • Hk, Hong Kong
      • Hong Kong, Hong Kong
      • New Territories, Hong Kong
      • Sha Tin, Hong Kong
  • Hungary
      • Budapest, Hungary
      • Budapest N/A, Hungary
      • Zalaegerszeg-P Zva N/A, Hungary
  • Indonesia
      • Jakarta, Indonesia
  • Korea, Republic of
      • Hwasun Gun, Korea, Republic of
      • Seongnam-Si, Gyeonggi-Do, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Jalan Cheras N/A, Malaysia
      • Kota Kinabalu, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/A, Malaysia
      • Subang Jaya, Malaysia
  • Mexico
      • Acapulco, Guerrero, Mexico
      • Aguascalientes, Mexico
      • Chihuahua, Mexico
      • Ciudad De Mexico, Mexico
      • Cuernavaca, Mexico
      • Distrito Federal, Mexico
      • Durango, Mexico
      • Guadalajara, Mexico
      • Leon, Mexico
      • Mexico City, Mexico
      • Mexico, D.F., Mexico
      • Monterrey, Mexico
      • Oaxaca, Mexico
      • Veracruz, Mexico
      • Zamora, Mexico
  • New Zealand
      • Christchurch, New Zealand
      • Grafton, New Zealand
      • Hamilton, New Zealand
      • Palmerston North, New Zealand
      • Wellington, New Zealand
  • Poland
      • Gdansk, Poland
      • Lodz, Poland
      • Opole, Poland
      • Otwock, Poland
      • Wroclaw, Poland
  • Puerto Rico
      • Ponce, Puerto Rico
      • San Juan, Puerto Rico
  • Romania
      • Brasov, Romania
      • Bucuresti, Romania
      • Cluj-Napoca, Romania
      • Iasi, Romania
  • Russian Federation
      • Barnaul, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Obninsk, Russian Federation
      • Omsk, Russian Federation
      • Pyatigorsk, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Saint-Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Ufa, Russian Federation
  • Singapore
      • Singapore, Singapore
  • Spain
      • Badajoz, Spain
      • Barakaldo Vizcaya, Spain
      • Barcelona, Spain
      • Cordoba, Spain
      • Hospitalet. Barcelona, Spain
      • La Coruña, Spain
      • Madrid, Spain
      • Palma De Mallorca, Spain
      • Salamanca, Spain
      • Santa Cruz De Tenerife, Spain
      • Sevilla, Spain
      • Toledo, Spain
      • Valencia, Spain
  • Taiwan
      • Kaohsiung, Taiwan
      • Kaohsiung County, Taiwan
      • Taoyuan, Taiwan
  • Thailand
      • Bangkok, Thailand
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • Bellflower, California, United States
      • Berkeley, California, United States
      • Beverly Hills, California, United States
      • Duarte, California, United States
      • Encinitas, California, United States
      • Glendale, California, United States
      • Greenbrae, California, United States
      • La Jolla, California, United States
      • Laguna Hills, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Marina Del Rey, California, United States
      • Rancho Mirage, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Santa Rosa, California, United States
      • Stanford, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Fort Collins, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
      • Manchester, Connecticut, United States
      • New Britain, Connecticut, United States
      • Norwalk, Connecticut, United States
      • Norwich, Connecticut, United States
      • Southington, Connecticut, United States
      • Stamford, Connecticut, United States
      • Torrington, Connecticut, United States
      • Trumball, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Boca Raton, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • Port Saint Lucie, Florida, United States
      • South Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Savannah, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Post Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Decatur, Illinois, United States
      • Harvey, Illinois, United States
      • Niles, Illinois, United States
      • Peoria, Illinois, United States
      • Urbana, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Lafayette, Indiana, United States
      • Merrillville, Indiana, United States
      • Muncie, Indiana, United States
    • Iowa
      • Bettendorf, Iowa, United States
    • Kansas
      • Westwood, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
      • Scarborough, Maine, United States
    • Maryland
      • Easton, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Dearborn, Michigan, United States
      • Detroit, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Lansing, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
    • Missouri
      • St. Joseph, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Hooksett, New Hampshire, United States
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Hackensack, New Jersey, United States
      • Livingston, New Jersey, United States
      • Morristown, New Jersey, United States
      • New Brunswick, New Jersey, United States
      • Paramus, New Jersey, United States
    • New Mexico
      • Los Alamos, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Binghamton, New York, United States
      • Bronx, New York, United States
      • Brooklyn, New York, United States
      • Buffalo, New York, United States
      • Cooperstown, New York, United States
      • Dunkirk, New York, United States
      • East Setauket, New York, United States
      • East Syracuse, New York, United States
      • Fresh Meadows, New York, United States
      • Glens Falls, New York, United States
      • Mt. Kisco, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Stony Brook, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
      • Hendersonville, North Carolina, United States
      • High Point, North Carolina, United States
      • Huntersville, North Carolina, United States
      • Pinehurst, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Elyria, Ohio, United States
      • Massillon, Ohio, United States
      • Middletown, Ohio, United States
      • Sandusky, Ohio, United States
    • Oklahoma
      • Bethany, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Galveston, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • Temple, Texas, United States
      • The Woodlands, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Hampton, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed prostate cancer
  • Prostate cancer progression after previous chemotherapy as assessed by the investigator
  • Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
  • Serum testosterone of less than 50ng/dL (less than 2.0 nM)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)

Exclusion Criteria:

  • Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
  • Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
  • Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
  • History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
  • Known brain metastasis (ie, spread of cancer to the brain)

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?

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Helpful Links

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 Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR017479
  • 212082PCR3001 (OTHER: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
  • 2010-021425-13 (EUDRACT_NUMBER)

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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