Evidence map›Paper›PMID 31560066›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer.

E J Small, F Saad, S Chowdhury, S Oudard, B A Hadaschik, J N Graff, D Olmos, P N Mainwaring, J Y Lee, H Uemura and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
17.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Lancet (London, England) · 2024
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  14. Androgen Signaling in Prostate Cancer: When a Friend Turns Foe.Endocrine, metabolic & immune disorders drug targets · 2025
    Review
  15. Article
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  18. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 10 countries.

E J SmallHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. Electronic address: Eric.Small@ucsf.edu.
F SaadCentre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
S ChowdhuryGuy's, King's and St. Thomas' Hospitals, London; Sarah Cannon Research Institute, London, UK.
S OudardGeorges Pompidou Hospital, University René Descartes, Paris, France.
B A HadaschikUniversity of Duisburg-Essen, Essen; Ruprecht-Karls University Heidelberg, Heidelberg, Germany.
J N GraffVA Portland Health Care System, Portland; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
D OlmosSpanish National Cancer Research Centre (CNIO), Madrid; Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Málaga (IBIMA), Málaga, Spain.
P N MainwaringCentre for Personalized Nanomedicine, University of Queensland, Brisbane, Australia.
J Y LeeSt. Mary's Hospital of Catholic University, Seoul, South Korea.
H UemuraYokohama City University Medical Center, Yokohama, Japan.
P De PorreJanssen Research & Development, Beerse, Belgium.
A A SmithJanssen Research & Development, Spring House, PA.
K ZhangJanssen Research & Development, San Diego, CA.
A Lopez-GitlitzJanssen Research & Development, Los Angeles, CA.
M R SmithMassachusetts General Hospital Cancer Center, Boston, MA; Harvard Medical School, Boston, MA, USA.
Janssen (United States) · USCentre Hospitalier de l’Université de Montréal · CAHarvard University · USHeidelberg University · DEInstituto de Investigación Biomédica de Málaga · ESJanssen (Belgium) · BEKing's College Hospital · GBOregon Health & Science University · USSt. Paul's Hospital · KRUCSF Helen Diller Family Comprehensive Cancer Center · USUniversité Paris Cité · FRUniversity of Queensland · AUYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) events required for planned final OS analysis. Here, we report the results of a second pre-specified interim analysis (IA2).

methodsOne thousand two hundred and seven patients with nmCRPC were randomized 2 : 1 to apalutamide (240 mg daily) or placebo. The primary end point of the study was MFS. Subsequent therapy for metastatic CRPC was permitted. When the primary end point was met, the study was unblinded. Patients receiving placebo who had not yet developed metastases were offered open-label apalutamide. At IA2, pre-specified analysis of OS was undertaken, using a group-sequential testing procedure with O'Brien-Fleming-type alpha spending function. Safety and second progression-free survival (PFS2) were assessed.

resultsMedian follow-up was 41 months. With 285 (67% of required) OS events, apalutamide was associated with an improved OS compared with placebo (HR 0.75; 95% CI 0.59-0.96; P = 0.0197), although the P-value did not cross the pre-specified O'Brien-Fleming boundary of 0.0121. Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45-0.68). At IA2, 69% of placebo-treated and 40% of apalutamide-treated patients had received subsequent life-prolonging therapy for metastatic CRPC. No new safety signals were observed.

conclusionIn patients with nmCRPC, apalutamide was associated with a 25% reduction in risk of death compared with placebo. This OS benefit was observed despite crossover of placebo-treated patients and higher rates of subsequent life-prolonging therapy for the placebo group.

Indexed as

Androgen Receptor AntagonistsCross-Over StudiesDisease ProgressionHumansMaleMiddle AgedPlacebosProgression-Free SurvivalProstatic Neoplasms, Castration-ResistantThiohydantoinsTime FactorsAndrogen Receptor AntagonistsapalutamidePlacebosThiohydantoinsapalutamidenon-metastatic castration-resistant prostate canceroverall survivalsubsequent therapy

Identifiers

PMID31560066
PMCPMC6927320
OpenAlexW2976281902

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.