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Prostate CancerPhase 3NCT00887198

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

A Phase 3 study testing Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 134 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,088 participants
Where
134 sitesin 11 countries
Study dates
28 Apr 2009to 25 May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

134 sites in 11 countries.

134 sites in 11 countries

United States48 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Bellflower, California

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Canton, Ohio

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Dearborn, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    East Syracuse, New York

  • Study site

    Fort Myers, Florida

  • Study site

    Gainesville, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Kansas City, Kansas

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Marina del Rey, California

  • Study site

    Metairie, Louisiana

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Hyde Park, New York

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Omaha, Nebraska

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Sacramento, California

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Syracuse, New York

  • Study site

    Tucson, Arizona

Other trials in United States

Australia19 sites

  • Study site

    Adelaide

  • Study site

    Camperdown

  • Study site

    Footscray

  • Study site

    Frankston

  • Study site

    Garran

  • Study site

    Geelong

  • Study site

    Heidelberg

  • Study site

    Herston

  • Study site

    Hornsby

  • Study site

    Kogarah

  • Study site

    Kurralta Park

  • Study site

    Lismore

  • Study site

    Liverpool

  • Study site

    Malvern

  • Study site

    Parkville

  • Study site

    Perth

  • Study site

    South Brisbane

  • Study site

    Southport

  • Study site

    Subiaco

Other trials in Australia

Germany13 sites

  • Study site

    Aachen

  • Study site

    Berlin

  • Study site

    Braunschweig

  • Study site

    Dresden

  • Study site

    Düsseldorf

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Homburg

  • Study site

    Kempen

  • Study site

    Leipzig

  • Study site

    München

  • Study site

    Münster

  • Study site

    Wuppertal

Other trials in Germany

United Kingdom11 sites

  • Study site

    Birmingham

  • Study site

    Cambridge

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Newcastle upon Tyne

  • Study site

    Oxford

  • Study site

    Sutton

  • Study site

    Whitchurch

Other trials in United Kingdom

Canada10 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

France9 sites

  • Study site

    Caen

  • Study site

    Clichy

  • Study site

    Dijon

  • Study site

    La Roche-sur-Yon

  • Study site

    Lyon

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Tours

  • Study site

    Villejuif

Other trials in France

Spain7 sites

  • Study site

    A Coruña

  • Study site

    Barcelona

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Madrid

  • Study site

    Oviedo

  • Study site

    Santander

  • Study site

    Santiago de Compostela

Other trials in Spain

Belgium6 sites

  • Study site

    Aalst

  • Study site

    Antwerp

  • Study site

    Ghent

  • Study site

    Hasselt

  • Study site

    Leuven

  • Study site

    Roeselare

Other trials in Belgium

Sweden5 sites

  • Study site

    Gothenburg

  • Study site

    Malmö

  • Study site

    Stockholm

  • Study site

    Uppsala

  • Study site

    Vaxjo

Other trials in Sweden

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Heerlen

  • Study site

    Nijmegen

  • Study site

    Rotterdam

Other trials in Netherlands

Greece2 sites

  • Study site

    Athens

  • Study site

    Larissa

Other trials in Greece

About this study

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

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).

Read the 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.

Conditions
Prostate Cancer
Being tested
Abiraterone acetate, Placebo, Prednisone
Keywords
Prostate cancer, Abiraterone acetate, CB7630, CRPC, Metastatic castration-resistant prostate cancer, hormone refractory prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

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

  • PlaceboDrug

    4 placebo tablets per day taken orally.

  • PrednisoneDrug

    5 mg tablet orally twice daily.

Study groups in NCT00887198
Study groupRoleWhat they receive
Placebo + prednisonePlacebo comparatorPlacebo plus prednisone
Receives: Drug: Placebo; Drug: Prednisone
Abiraterone + prednisoneExperimentalAbiraterone acetate plus prednisone
Receives: Drug: Abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival is defined as the time from randomization to date of death from any cause.

    Measured: From randomization (Day 1) up to end of study (Month 60)

  2. Radiographic Progression-free Survival (rPFS)

    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.

    Measured: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Secondary outcomes (9)

  1. Time to Opiate Use for Prostate Cancer Pain

    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.

    Measured: From randomization (Day 1) up to first opiate use or end of study (Month 60)

  2. Time to Initiation of Cytotoxic Chemotherapy

    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.

    Measured: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

  3. Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point

    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.

    Measured: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

  4. Time to Prostate-specific Antigen (PSA) Progression

    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.

    Measured: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

  5. Number of Participants With Treatment Emergent Adverse Events

    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.

    Measured: From first dose of study drug up to 30 days after the last dose of study drug

  6. Mean Plasma Concentrations of Abiraterone

    Measured: Up to Cycle 5, Day 1

  7. Maximum Plasma Concentrations of Abiraterone

    Measured: Up to Cycle 5, Day 1

  8. Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])

    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.

    Measured: Up to Cycle 5, Day 1

  9. Elimination Half-Life (t1/2)

    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).

    Measured: Up to Cycle 5, Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2009 (estimated)
  2. Study start28 Apr 2009
  3. Primary completion31 Mar 2014
  4. Study completion25 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,088 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887198
Sponsor's protocol ID
CR016927
Other IDs
COU-AA-302, 2008-008004-41, 2008
Status last verified
Jan 2025
First submitted
18 Apr 2009
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Zhao J, Cai X, Mo Z, Zhao D, Wang J, Yang Z, Long X, Li Y, Chen D, Li J, Zhou Z, Li S, Li Y. Association between concomitant ACEI/ARBs use and survival of patients with prostate cancer receiving abiraterone acetate: A post-hoc analysis of two randomized trials. Prostate Cancer Prostatic Dis. 2026 Jun 12. doi: 10.1038/s41391-026-01128-1. Online ahead of print.

    PubMed 42286315

  • Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sanchez-Iglesias A, di Capua C, Castro E, Ferrer C, Sanchez-Hernandez A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6.

    PubMed 34373138

  • Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.

    PubMed 28939004

  • de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.

    PubMed 27402060

  • Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

    PubMed 26609008

  • Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naive metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.

    PubMed 25985882

  • Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

    PubMed 25829400

  • Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.

    PubMed 25624432

  • Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

    PubMed 25601341

  • Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.

    PubMed 25593303

  • Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

    PubMed 24787968

  • Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

    PubMed 24647231

  • Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.

    PubMed 24075621

  • Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.

    PubMed 23228172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 134 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Australia, Germany, United Kingdom, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization (Day 1) up to end of study (Month 60)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887198, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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