Evidence map›Paper›PMID 21612468›Full record

Trial reportThe New England journal of medicine2011

Abiraterone and increased survival in metastatic prostate cancer.

Johann S de Bono, Christopher J Logothetis, Arturo Molina, Karim Fizazi, Scott North, Luis Chu, Kim N Chi, Robert J Jones, Oscar B Goodman, Fred Saad and 23 more

14 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 14 registered trials, which are not on this map. Cited by 2,103 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2,103citing papers in PubMed, 11 pooled it
311.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00638690 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

TypeinterventionalSponsorCougar Biotechnology, Inc.Ran2008 to 2012Enrolled1,195ConditionsProstatic NeoplasmsArmsPlacebo, Abiraterone acetate, Prednisone/prednisolone
NCT01120470 phase2completednot on this map

A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2010 to 2014Enrolled74ConditionsCastration Resistant Prostate CancerArmsOGX-427, Prednisone
NCT01848067 phase1 / phase2completednot on this mapstarted 2013, after this paper: background citation

A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2013 to 2016Enrolled9ConditionsAdenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate CancerArmsAlisertib, Abiraterone acetate, Prednisone
NCT01859221 nacompletednot on this mapstarted 2013, after this paper: background citation

Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

TypeinterventionalSponsorUniversity of FloridaRan2013 to 2022Enrolled39ConditionsOligometastatic Prostate CancerArmsStereotactic radiation
NCT01981707 phase2 / phase3terminatednot on this mapstarted 2013, after this paper: background citation

F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2013 to 2016Enrolled12ConditionsCastration-resistant Prostate CancerArmsF-Choline-PET
NCT02867020 phase2completednot on this mapstarted 2017, after this paper: background citation

Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

TypeinterventionalSponsorLatin American Cooperative Oncology GroupRan2017 to 2021Enrolled128ConditionsProstate CancerArmsApalutamide, Abiraterone, ADT, Prednisone
NCT03145285 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma

TypeinterventionalSponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRan2017 to 2021Enrolled10ConditionsCushing Syndrome, Adrenocortical CarcinomaArmsAbiraterone Acetate
NCT03176381 completednot on this mapstarted 2017, after this paper: background citation

Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC

TypeobservationalSponsorTianjin Medical University Second HospitalRan2017 to 2023Enrolled110ConditionsMetastatic Castration-resistant Prostate Cancer
NCT03565835 phase2completednot on this mapstarted 2018, after this paper: background citation

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

TypeinterventionalSponsorMontefiore Medical CenterRan2018 to 2021Enrolled31ConditionsProstatic NeoplasmsArmsAbiraterone Acetate, Prednisone
NCT03829930 phase1terminatednot on this mapstarted 2019, after this paper: background citation

A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer

TypeinterventionalSponsorGeorge Washington UniversityRan2019 to 2020Enrolled6ConditionsProstate AdenocarcinomaArmsEntinostat, Enzalutamide
NCT04015622 phase2active not recruitingnot on this mapstarted 2020, after this paper: background citation

A Randomized Phase II Trial Comparing Biomarker Directed Therapy Versus Clinician's Choice of Enzalutamide or Docetaxel in Patients With Advanced Prostate Cancer Post Abiraterone

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2020 to 2026Enrolled100ConditionsMetastatic Castration-Resistant Prostate Cancer (mCRPC)ArmsEnzalutamide, Docetaxel
NCT04225910 early_phase1unknown statusnot on this mapstarted 2020, after this paper: background citation

Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

TypeinterventionalSponsorXinhua Hospital, Shanghai Jiao Tong University School of MedicineRan2020 to 2021Enrolled20ConditionsMetastatic Castration-resistant Prostate CancerArms225Ac-PSMA
NCT04736108 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate

TypeinterventionalSponsorWest China HospitalRan2021 to 2024Enrolled50ConditionsProstate CancerArmsAbiraterone acetate, Prednisolone, Goserelin
NCT07717268 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.

TypeinterventionalSponsorInstituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología RadioterápicRan2024 to 2030Enrolled51ConditionsProstatic Neoplasms, Castration-ResistantArmsXtandi, Zytiga® (Abiraterone Acetate), SBRT
3 · Its place in the literature

Who cites it

2,103 citing papers in PubMed, 11 syntheses or guidelines pooled it, 4,364 citations in OpenAlex.

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  8. Cabazitaxel versus abiraterone or enzalutamide for metastatic castration-resistant prostate cancer following docetaxel failure: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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  12. Sequential Enzalutamide-Docetaxel Versus Abiraterone-Docetaxel Therapy in Castration-Resistant Prostate Cancer: A Subanalysis of the ENABLE Study.International journal of urology : official journal of the Japanese Urological Association · 2026
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2,043 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 20 institutions in 7 countries.

Johann S de BonoInstitute of Cancer Research and Royal Marsden Hospital, Sutton, Surrey, United Kingdom. johann.de-bono@icr.ac.uk
Christopher J Logothetis
Arturo Molina
Karim Fizazi
Scott North
Luis Chu
Kim N Chi
Robert J Jones
Oscar B Goodman
Fred Saad
John N Staffurth
Paul Mainwaring
Stephen Harland
Thomas W Flaig
Thomas E Hutson
Tina Cheng
Helen Patterson
John D Hainsworth
Charles J Ryan
Cora N Sternberg
Susan L Ellard
Aude Fléchon
Mansoor Saleh
Mark Scholz
Eleni Efstathiou
Andrea Zivi
Diletta Bianchini
Yohann Loriot
Nicole Chieffo
Thian Kheoh
Christopher M Haqq
Howard I Scher
COU-AA-301 Investigators
Los Angeles City College · USBC Cancer Agency · CAInstitut Gustave Roussy · FRRoyal Marsden Hospital · GBThe University of Texas MD Anderson Cancer Center · USAustralasia Paediatric Endocrine Group · AUCancer Institute (WIA) · INCentre Léon Bérard · FRGeorgia Cancer Specialists · USHematology Oncology Consultants · USInstitute of Cancer Research · GBMemorial Sloan Kettering Cancer Center · USNini Hospital · LBOncology Specialists · USSarah Cannon Research Institute · GBTexas Oncology · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversité de Montréal · CAUniversity College London · GBUniversity of Calgary · CA

Funding

SPORE In Prostate CancerP50CA092629 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Yu Chen, MICHAEL J MORRIS · 2001 to 2026
$63.0M
Medical Research CouncilNCI NIH HHS P50 CA092629
6 · The paper itself

Abstract

backgroundBiosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.

methodsWe randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.

resultsAfter a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate-prednisone group than in the placebo-prednisone group.

conclusionsThe inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.).

Indexed as

AgedAndrogen AntagonistsAndrogensAndrostenesAndrostenolsAntineoplastic Combined Chemotherapy ProtocolsDisease ProgressionDouble-Blind MethodFatigueHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisPrednisoneProstatic NeoplasmsabirateroneAndrogen AntagonistsAndrogensAndrostenesAndrostenolsPrednisoneSteroid 17-alpha-Hydroxylase

Identifiers

PMID21612468
PMCPMC3471149
OpenAlexW2110534364

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.