Evidence map›Paper›PMID 27477525›Full record

Trial reportEuropean urology2017

Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study.

Tomasz M Beer, Andrew J Armstrong, Dana Rathkopf, Yohann Loriot, Cora N Sternberg, Celestia S Higano, Peter Iversen, Christopher P Evans, Choung-Soo Kim, Go Kimura and 11 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 211 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 19 pooled it
24.9field-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.

NCT01212991 phase3completednot on this map

Prevail: a multinational phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral mdv3100 in chemotherapy-naïve patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy

TypeinterventionalSponsorPfizerRan2010 to 2019Enrolled1,717ConditionsProstate CancerArmsEnzalutamide, Placebo
NCT07316686 phase1recruitingnot on this mapstarted 2026, after this paper: background citation

Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma

TypeinterventionalSponsorInstituto do Cancer do Estado de São PauloRan2026 to 2026Enrolled18ConditionsProstate Cancer (Adenocarcinoma)ArmsDocetaxel 50mg/m2, Docetaxel 60mg/m2, Docetaxel 75 mg/m², 177Lu-PSMA-I&T
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

211 citing papers in PubMed, 19 syntheses or guidelines pooled it, 410 citations in OpenAlex.

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  5. Comparative effectiveness of first-line systemic treatments for metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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  14. Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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151 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 18 institutions in 12 countries.

Tomasz M BeerKnight Cancer Institute, Oregon Health & Science University, Portland, OR, USA. Electronic address: beert@ohsu.edu.
Andrew J ArmstrongDuke Cancer Institute, Durham, NC, USA.
Dana RathkopfMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Yohann LoriotInstitut Gustave-Roussy, Villejuif, France.
Cora N SternbergSan Camillo and Forlanini Hospitals, Rome, Italy.
Celestia S HiganoUniversity of Washington, Seattle Cancer Care Alliance, Seattle, WA, USA.
Peter IversenRigshospitalet, Copenhagen, Denmark.
Christopher P EvansUC Davis Cancer Center, Sacramento, CA, USA.
Choung-Soo KimAsan Medical Center, Seoul, Korea.
Go KimuraNippon Medical School, Tokyo, Japan.
Kurt MillerCharité Universitätsmedizin, Berlin, Germany.
Fred SaadUniversity of Montreal Hospital Center, Montreal, QC, Canada.
Anders S BjartellSkåne University Hospital, Malmö, Sweden.
Michael BorreAarhus University Hospital, Aarhus, Denmark.
Peter MuldersRadboud University Medical Center, Nijmegen, Netherlands.
Teuvo L TammelaTampere University Hospital and University of Tampere, Tampere, Finland.
Teresa ParliMedivation, San Francisco, CA, USA.
Suha SariMedivation, San Francisco, CA, USA.
Steve van OsAstellas Pharma Europe, Leiden, The Netherlands.
Ad TheeuwesAstellas Pharma Europe, Leiden, The Netherlands.
Bertrand TombalCliniques Universitaires Saint-Luc, Brussels, Belgium.
Astellas Pharma (Netherlands) · NLAarhus University Hospital · DKAsan Medical Center · KRCarlo Forlanini Hospital · ITCharité - Universitätsmedizin Berlin · DECliniques Universitaires Saint-Luc · BEDuke Cancer InstituteInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USNippon Medical School · JPOregon Health & Science University · USRadboud University Nijmegen · NLRigshospitalet · DKSeattle Cancer Care Alliance · USSkåne University Hospital · SETampere University Hospital · FIUC Davis Comprehensive Cancer CenterUniversité de Montréal · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.28-0.37; p<0.0001) and the risk of death by 23% (HR 0.77, 95% CI 0.67-0.88; p=0.0002). Median investigator-assessed rPFS was 20.0 mo (95% CI 18.9-22.1) in the enzalutamide arm and 5.4 mo (95% CI 4.1-5.6) in the placebo arm. Median OS was 35.3 mo (95% CI 32.2-not yet reached) in the enzalutamide arm and 31.3 mo (95% CI 28.8-34.2) in the placebo arm. At the time of the OS analysis, 167 patients in the placebo arm had crossed over to receive enzalutamide. The most common adverse events in the enzalutamide arm were fatigue, back pain, constipation, and arthralgia. This final analysis of PREVAIL provides more complete assessment of the clinical benefit of enzalutamide. PREVAIL is registered on ClinicalTrials.gov as NCT01212991. PATIENT SUMMARY: According to data from longer follow-up, enzalutamide continued to provide benefit over placebo in patients with metastatic castration-resistant prostate cancer.

Indexed as

Antineoplastic AgentsBenzamidesHumansMaleNitrilesPhenylthiohydantoinProstatic Neoplasms, Castration-ResistantSurvival AnalysisAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoinAndrogen receptor signaling inhibitorEnzalutamideMetastatic castration-resistant prostate cancerOverall survivalRadiographic progression-free survival

Identifiers

PMID27477525
PMCPMC5570461
OpenAlexW2489425084

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.