Evidence map›Paper›PMID 27195316›Full record

Trial reportInvestigative and clinical urology2016

The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.

Choung-Soo Kim, Ad Theeuwes, Dong Deuk Kwon, Young Deuk Choi, Byung Ha Chung, Hyun Moo Lee, Kang Hyun Lee, Sang Eun Lee

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Investigative and clinical urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01212991 (PREVAIL), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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.

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
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
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

8 authors.

Choung-Soo KimDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ad TheeuwesBiostatistics, Astellas Pharma Europe B.V., Leiden, The Netherlands.
Dong Deuk KwonDepartment of Urology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Korea.
Young Deuk ChoiDepartment of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
Byung Ha ChungDepartment of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Hyun Moo LeeDepartment of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kang Hyun LeeDepartment of Urology, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.
Sang Eun LeeDepartment of Urology, Seoul National University Bundang Hospital, Seongnam, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. MATERIALS AND

methodsAsymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event.

resultsOf 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02-2.24) for centrally assessed rPFS, 0.77 (0.28-2.15) for OS, 0.21 (0.08-0.51) for time to chemotherapy, and 0.31 (0.17-0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97-1.10).

conclusionsIn Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population (ClinicalTrials.gov Identifier: NCT01212991).

Indexed as

AdenocarcinomaAdministration, OralAdultAgedAged, 80 and overAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBenzamidesDisease ProgressionDouble-Blind MethodHumansKallikreinsMaleMiddle AgedNitrilesPhenylthiohydantoinAntineoplastic Agents, HormonalBenzamidesenzalutamideKallikreinsKLK3 protein, humanNitrilesPhenylthiohydantoinProstate-Specific AntigenAntineoplastic agentsCastration-resistant prostatic neoplasmsDisease-free survivalMDV 3100Republic of Korea

Identifiers

PMID27195316
PMCPMC4869571

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.