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Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10286365" target="_blank" >RIV/00216208:11110/14:10286365 - isvavai.cz</a>

  • Alternative codes found

    RIV/00216208:11120/14:43909454

  • Result on the web

    <a href="http://dx.doi.org/10.1016/S1470-2045(14)70129-9" target="_blank" >http://dx.doi.org/10.1016/S1470-2045(14)70129-9</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/S1470-2045(14)70129-9" target="_blank" >10.1016/S1470-2045(14)70129-9</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study

  • Original language description

    Background The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. Methods This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen (PSA) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160 mg/day. The primary outcome was the proportion of patients with an 80% or greater decline in PSA at week 25. All analyses included all patients who had received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT01302041. Findings 67 men were enrolled into

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

  • CEP classification

    FJ - Surgery including transplantology

  • OECD FORD branch

Result continuities

  • Project

  • Continuities

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Others

  • Publication year

    2014

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Lancet Oncology

  • ISSN

    1470-2045

  • e-ISSN

  • Volume of the periodical

    15

  • Issue of the periodical within the volume

    6

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    9

  • Pages from-to

    592-600

  • UT code for WoS article

    000335512100046

  • EID of the result in the Scopus database