Evidence map›Paper›PMID 28578607›Full record

Trial reportThe New England journal of medicine2017

Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.

Karim Fizazi, NamPhuong Tran, Luis Fein, Nobuaki Matsubara, Alfredo Rodriguez-Antolin, Boris Y Alekseev, Mustafa Özgüroğlu, Dingwei Ye, Susan Feyerabend, Andrew Protheroe and 6 more

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

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 1,114 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,114citing papers in PubMed, 7 pooled it
178.1field-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.

NCT01715285 phase3completednot on this map

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

TypeinterventionalSponsorJanssen Research & Development, LLCRan2013 to 2022Enrolled1,209ConditionsProstate NeoplasmsArmsAbiraterone acetate, Prednisone, Androgen deprivation therapy (ADT), Abiraterone acetate Placebo, Prednisone Placebo
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
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
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
3 · Its place in the literature

Who cites it

1,114 citing papers in PubMed, 7 syntheses or guidelines pooled it, 2,163 citations in OpenAlex.

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  7. 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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  11. 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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  14. Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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1,054 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 1 institution in 2 countries.

Karim FizaziFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
NamPhuong TranFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Luis FeinFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Nobuaki MatsubaraFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Alfredo Rodriguez-AntolinFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Boris Y AlekseevFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Mustafa ÖzgüroğluFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Dingwei YeFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Susan FeyerabendFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Andrew ProtheroeFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Peter De PorreFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Thian KheohFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Youn C ParkFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Mary B ToddFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
Kim N ChiFrom Gustave Roussy, University of Paris Sud, Villejuif, France (K.F.); Janssen Research and Development, Los Angeles (N.T.), Beerse, Belgium (P.D.P.), San Diego, CA (T.K.), and Raritan, NJ (Y.C.P.); Instituto de Oncologia de Rosário, Rosário, Argentina (L.F.); National Cancer Center Hospital East, Chiba, Japan (N.M.); 12 de Octubre University Hospital, Madrid (A.R.-A.); P.A. Hertsen Moscow Cancer Research Institute, Moscow (B.Y.A.); Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey (M.Ö.); Fudan University Shanghai Cancer Center, Shanghai, China (D.Y.); Studienpraxis Urologie, Nürtingen, Germany (S.F.); Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom (A.P.); Janssen Global Services, Raritan, NJ (M.B.T.); and BC Cancer Agency, Vancouver, Canada (K.N.C.).
LATITUDE Investigators
Université Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer.

methodsIn this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival.

resultsAfter a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001). The median length of radiographic progression-free survival was 33.0 months in the abiraterone group and 14.8 months in the placebo group (hazard ratio for disease progression or death, 0.47; 95% CI, 0.39 to 0.55; P<0.001). Significantly better outcomes in all secondary end points were observed in the abiraterone group, including the time until pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, and prostate-specific antigen progression (P<0.001 for all comparisons), along with next symptomatic skeletal events (P=0.009). These findings led to the unanimous recommendation by the independent data and safety monitoring committee that the trial be unblinded and crossover be allowed for patients in the placebo group to receive abiraterone. Rates of grade 3 hypertension and hypokalemia were higher in the abiraterone group.

conclusionsThe addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly increased overall survival and radiographic progression-free survival in men with newly diagnosed, metastatic, castration-sensitive prostate cancer. (Funded by Janssen Research and Development; LATITUDE ClinicalTrials.gov number, NCT01715285 .).

Indexed as

Abiraterone AcetateAdultAgedAged, 80 and overAndrogen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsHumansMaleMiddle AgedNeoplasm MetastasisPrednisoloneProstatic NeoplasmsSteroid 17-alpha-HydroxylaseSurvival AnalysisAbiraterone AcetateAndrogen AntagonistsPrednisoloneSteroid 17-alpha-Hydroxylase

Identifiers

PMID28578607
OpenAlexW2620798309

What OpenQuestion holds

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Registered trials

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.