Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

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: Approved for marketing
• Conditions: Urogenital Neoplasms; Genital Neoplasms, Male; Prostate Neoplasms; Genital Diseases, Male
• Intervention / Treatment: Drug: Abiraterone Acetate; Drug: Prednisone\Prednisolone

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: Expanded Access

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Sternberg CN, Castellano D, Daugaard G, Geczi L, Hotte SJ, Mainwaring PN, Saad F, Souza C, Tay MH, Garrido JM, Galli L, Londhe A, De Porre P, Goon B, Lee E, McGowan T, Naini V, Todd MB, Molina A, George DJ; Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol. 2014 Oct;15(11):1263-8. doi: 10.1016/S1470-2045(14)70417-6. Epub 2014 Sep 18. Erratum In: Lancet Oncol. 2014 Nov;15(12):e528.

Helpful Links

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

Study record dates

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (ESTIMATE): October 8, 2010

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Abiraterone Acetate; Metastatic Castration-Resistant Prostate Cancer (CRPC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Prostatic Diseases; Neoplasms; Prostatic Neoplasms; Urogenital Neoplasms; Genital Neoplasms, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisolone; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: CR017479; 212082PCR3001 (OTHER: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); 2010-021425-13 (EUDRACT_NUMBER)