Evidence map›Paper›PMID 32907777›Full record

Trial reportEuropean urology2021

Apalutamide and Overall Survival in Prostate Cancer.

Matthew R Smith, Fred Saad, Simon Chowdhury, Stéphane Oudard, Boris A Hadaschik, Julie N Graff, David Olmos, Paul N Mainwaring, Ji Youl Lee, Hiroji Uemura and 8 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05649943 (APPROACH), which is not on this map. Cited by 132 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 10 pooled it
21.0field-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.

NCT05649943 narecruitingnot on this mapstarted 2023, after this paper: background citation

APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2023 to 2029Enrolled566ConditionsMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)ArmsAPA + ADT, Local Treatmetn RT or RP
3 · Its place in the literature

Who cites it

132 citing papers in PubMed, 10 syntheses or guidelines pooled it, 284 citations in OpenAlex.

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  11. 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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  19. Navigating drug-drug interactions with apalutamide.Prostate cancer and prostatic diseases · 2026
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72 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 9 countries.

Matthew R SmithMassachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA. Electronic address: MRSMITH@mgh.harvard.edu.
Fred SaadCentre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, Québec, Canada.
Simon ChowdhuryGuy's, King's, and St. Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK.
Stéphane OudardGeorges Pompidou Hospital, University de Paris, Paris, France.
Boris A HadaschikUniversity of Duisburg-Essen, Essen, and Ruprecht-Karls University Heidelberg, Heidelberg, Germany.
Julie N GraffVA Portland Health Care System, Portland and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
David OlmosSpanish National Cancer Research Centre (CNIO), Madrid and Biomedical Research Institute of Málaga (IBIMA), Spain.
Paul N MainwaringCanossa Hospital, Oxley, Queensland, Australia.
Ji Youl LeeSt. Mary's Hospital of Catholic University, Seoul, South Korea.
Hiroji UemuraYokohama City University Medical Center, Yokohama, Japan.
Peter De PorreJanssen Research & Development, Beerse, Belgium.
Andressa A SmithJanssen Research & Development, Spring House, PA, USA.
Sabine D Brookman-MayJanssen Research & Development, Los Angeles, CA, USA; Ludwig Maximilians University, Munich, Germany.
Susan LiJanssen Research & Development, Spring House, PA, USA.
Ke ZhangJanssen Research & Development, San Diego, CA, USA.
Brendan RooneyJanssen Research & Development, High Wycombe, UK.
Angela Lopez-GitlitzJanssen Research & Development, Los Angeles, CA, USA.
Eric J SmallHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Janssen (United States) · USCanossa Private Hospital · AUCentre Hospitalier de l’Université de Montréal · CAInstituto de Investigación Biomédica de Málaga · ESJanssen (Belgium) · BEJanssen (United Kingdom) · GBKing's College Hospital · GBLudwig-Maximilians-Universität München · DEMassachusetts General Hospital · USSt. Paul's Hospital · KRUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Duisburg-Essen · DEVA Portland Health Care System · USYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature.

objectiveWe report the prespecified event-driven final analysis for OS. DESIGN, SETTING, AND

participantsA total of 1207 patients with nmCRPC (diagnosed by conventional imaging) were randomised 2:1 to apalutamide (240mg/d) or placebo, plus on-going androgen deprivation therapy. After MFS was met and the study was unblinded, 76 (19%) patients still receiving placebo crossed over to apalutamide. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: OS and time to cytotoxic chemotherapy (TTChemo) were analysed by group-sequential testing with O'Brien-Fleming-type alpha spending function. RESULTS AND LIMITATIONS: At median 52-mo follow-up, 428 deaths had occurred. The median treatment duration was 32.9 mo for apalutamide group and 11.5 mo for placebo group. Median OS was markedly longer with apalutamide versus placebo, reaching prespecified statistical significance (73.9 vs 59.9 mo, hazard ratio [HR]: 0.78 [95% confidence interval {CI}, 0.64-0.96]; p=0.016). Apalutamide also lengthened TTChemo versus placebo (HR: 0.63 [95% CI, 0.49-0.81]; p=0.0002). Discontinuation rates in apalutamide and placebo groups due to progressive disease were 43% and 74%, and due to adverse events 15% and 8.4%, respectively. Subsequent life-prolonging therapy was received by 371 (46%) patients in the apalutamide arm and by 338 (84%) patients in the placebo arm including 59 patients who received apalutamide after crossover. Safety was consistent with previous reports; when adverse events were adjusted for treatment exposure, rash had the greatest difference of incidence between the apalutamide and placebo groups.

conclusionsExtension of OS with apalutamide compared with placebo conferred impactful benefit in patients with nmCRPC. There was a 22% reduction in the hazard of death in the apalutamide group despite 19% crossover (placebo to apalutamide) and higher rates of subsequent therapy in the placebo group. PATIENT SUMMARY: With data presented herein, all primary and secondary study end points of SPARTAN were met; findings demonstrate the value of apalutamide as a treatment option for nonmetastatic castration-resistant prostate cancer.

Indexed as

AgedCross-Over StudiesHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantSurvival RateThiohydantoinsapalutamideThiohydantoinsApalutamideNonmetastatic castration-resistant prostate cancerOverall survivalSubsequent therapyTime to cytotoxic chemotherapy

Identifiers

PMID32907777
OpenAlexW3083310601

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.