Evidence map›Paper›PMID 23228172›Full record

Trial reportThe New England journal of medicine2013

Abiraterone in metastatic prostate cancer without previous chemotherapy.

Charles J Ryan, Matthew R Smith, Johann S de Bono, Arturo Molina, Christopher J Logothetis, Paul de Souza, Karim Fizazi, Paul Mainwaring, Josep M Piulats, Siobhan Ng and 24 more

Erratum issued 12 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 12 registered trials, which are not on this map. Cited by 1,322 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,322citing papers in PubMed, 11 pooled it
–field-weighted citation impact
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.

NCT00887198 phase3completednot on this map

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

TypeinterventionalSponsorJanssen Research & Development, LLCRan2009 to 2017Enrolled1,088ConditionsProstate CancerArmsAbiraterone acetate, Placebo, Prednisone
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
NCT01981707 phase2 / phase3terminatednot on this map

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
NCT03103724 phase2completednot on this mapstarted 2017, after this paper: background citation

A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2017 to 2021Enrolled68ConditionsCarcinoma ProstateArmsXtandi
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
NCT03737370 phase1completednot on this mapstarted 2018, after this paper: background citation

A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)

TypeinterventionalSponsorTufts Medical CenterRan2018 to 2025Enrolled43ConditionsMetastatic Castrate Resistant Prostate CancerArmsDocetaxel, Radium 223
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
NCT04409288 phase3terminatednot on this mapstarted 2020, after this paper: background citation

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer: An Open-label, Randomized, Cross-Over Trial.

TypeinterventionalSponsorChinese University of Hong KongRan2020 to 2023Enrolled74ConditionsProstate CancerArmsApalutamide, Enzalutamide
NCT06056791 phase1 / phase2completednot on this mapstarted 2023, after this paper: background citation

An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

TypeinterventionalSponsorInmune Bio, Inc.Ran2023 to 2025Enrolled12ConditionsCancer, Metastatic Castration-resistant Prostate Cancer, mCRPCArmsINKmune
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

1,322 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Pooled it
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  14. 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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  16. Evolution of AR and Non-AR Alterations in ctDNA of Patients with Metastatic Prostate Cancer Treated in the Phase III Alliance A031201 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  18. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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1,262 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors.

Charles J RyanGenitourinary Medical Oncology Program, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94115, USA. ryanc@medicine.ucsf.edu
Matthew R Smith
Johann S de Bono
Arturo Molina
Christopher J Logothetis
Paul de Souza
Karim Fizazi
Paul Mainwaring
Josep M Piulats
Siobhan Ng
Joan Carles
Peter F A Mulders
Ethan Basch
Eric J Small
Fred Saad
Dirk Schrijvers
Hendrik Van Poppel
Som D Mukherjee
Henrik Suttmann
Winald R Gerritsen
Thomas W Flaig
Daniel J George
Evan Y Yu
Eleni Efstathiou
Allan Pantuck
Eric Winquist
Celestia S Higano
Mary-Ellen Taplin
Youn Park
Thian Kheoh
Thomas Griffin
Howard I Scher
Dana E Rathkopf
COU-AA-302 Investigators

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Midcareer Investigator AwardK24CA121990 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, MATTHEW RAYMOND · 2007 to 2016
$1.9M
NCI NIH HHS K24 CA121990NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundAbiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy.

methodsIn this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival.

resultsThe study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P<0.001). Over a median follow-up period of 22.2 months, overall survival was improved with abiraterone-prednisone (median not reached, vs. 27.2 months for prednisone alone; hazard ratio, 0.75; 95% CI, 0.61 to 0.93; P=0.01) but did not cross the efficacy boundary. Abiraterone-prednisone showed superiority over prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use for cancer-related pain, prostate-specific antigen progression, and decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and abnormalities on liver-function testing were more common with abiraterone-prednisone.

conclusionsAbiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer. (Funded by Janssen Research and Development, formerly Cougar Biotechnology; ClinicalTrials.gov number, NCT00887198.).

Indexed as

Abiraterone AcetateAndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDouble-Blind MethodHumansMaleNeoplasm MetastasisPrednisoneProstatic NeoplasmsSurvival AnalysisAbiraterone AcetateAndrostadienesAntineoplastic Agents, HormonalPrednisone

Identifiers

PMID23228172
PMCPMC3683570

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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.