Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.
Identifieur interne : 001467 ( PubMed/Corpus ); précédent : 001466; suivant : 001468Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.
Auteurs : Karim Fizazi ; Christophe Massard ; Petri Bono ; Robert Jones ; Vesa Kataja ; Nicholas James ; Jorge A. Garcia ; Andrew Protheroe ; Teuvo L. Tammela ; Tony Elliott ; Leena Mattila ; John Aspegren ; Annamari Vuorela ; Peter Langmuir ; Mika MustonenSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2014.
English descriptors
- KwdEn :
- Administration, Oral, Aged, Androgen Receptor Antagonists (pharmacology), Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Invasiveness (pathology), Neoplasm Metastasis, Neoplasm Staging, Patient Safety, Patient Selection, Prognosis, Prostate-Specific Antigen (blood), Prostatic Neoplasms, Castration-Resistant (drug therapy), Prostatic Neoplasms, Castration-Resistant (mortality), Prostatic Neoplasms, Castration-Resistant (pathology), Pyrazoles (pharmacology), Survival Rate, Treatment Outcome.
- MESH :
- chemical , blood : Prostate-Specific Antigen.
- chemical , pharmacology : Androgen Receptor Antagonists, Pyrazoles.
- drug therapy : Prostatic Neoplasms, Castration-Resistant.
- mortality : Prostatic Neoplasms, Castration-Resistant.
- pathology : Neoplasm Invasiveness, Prostatic Neoplasms, Castration-Resistant.
- Administration, Oral, Aged, Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Patient Safety, Patient Selection, Prognosis, Survival Rate, Treatment Outcome.
Abstract
ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.
DOI: 10.1016/S1470-2045(14)70240-2
PubMed: 24974051
Links to Exploration step
pubmed:24974051Le document en format XML
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Electronic address: fizazi@igr.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Massard, Christophe" sort="Massard, Christophe" uniqKey="Massard C" first="Christophe" last="Massard">Christophe Massard</name><affiliation><nlm:affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</nlm:affiliation></affiliation></author><author><name sortKey="Bono, Petri" sort="Bono, Petri" uniqKey="Bono P" first="Petri" last="Bono">Petri Bono</name><affiliation><nlm:affiliation>Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Robert" sort="Jones, Robert" uniqKey="Jones R" first="Robert" last="Jones">Robert Jones</name><affiliation><nlm:affiliation>Velindre Cancer Centre, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kataja, Vesa" sort="Kataja, Vesa" uniqKey="Kataja V" first="Vesa" last="Kataja">Vesa Kataja</name><affiliation><nlm:affiliation>Kuopio University Hospital, Kuopio, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="James, Nicholas" sort="James, Nicholas" uniqKey="James N" first="Nicholas" last="James">Nicholas James</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital, Birmingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Garcia, Jorge A" sort="Garcia, Jorge A" uniqKey="Garcia J" first="Jorge A" last="Garcia">Jorge A. Garcia</name><affiliation><nlm:affiliation>Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name><affiliation><nlm:affiliation>Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Tammela, Teuvo L" sort="Tammela, Teuvo L" uniqKey="Tammela T" first="Teuvo L" last="Tammela">Teuvo L. 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Electronic address: fizazi@igr.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Massard, Christophe" sort="Massard, Christophe" uniqKey="Massard C" first="Christophe" last="Massard">Christophe Massard</name><affiliation><nlm:affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</nlm:affiliation></affiliation></author><author><name sortKey="Bono, Petri" sort="Bono, Petri" uniqKey="Bono P" first="Petri" last="Bono">Petri Bono</name><affiliation><nlm:affiliation>Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Robert" sort="Jones, Robert" uniqKey="Jones R" first="Robert" last="Jones">Robert Jones</name><affiliation><nlm:affiliation>Velindre Cancer Centre, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kataja, Vesa" sort="Kataja, Vesa" uniqKey="Kataja V" first="Vesa" last="Kataja">Vesa Kataja</name><affiliation><nlm:affiliation>Kuopio University Hospital, Kuopio, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="James, Nicholas" sort="James, Nicholas" uniqKey="James N" first="Nicholas" last="James">Nicholas James</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital, Birmingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Garcia, Jorge A" sort="Garcia, Jorge A" uniqKey="Garcia J" first="Jorge A" last="Garcia">Jorge A. Garcia</name><affiliation><nlm:affiliation>Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name><affiliation><nlm:affiliation>Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Tammela, Teuvo L" sort="Tammela, Teuvo L" uniqKey="Tammela T" first="Teuvo L" last="Tammela">Teuvo L. Tammela</name><affiliation><nlm:affiliation>Tampere University Hospital, Tampere, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Elliott, Tony" sort="Elliott, Tony" uniqKey="Elliott T" first="Tony" last="Elliott">Tony Elliott</name><affiliation><nlm:affiliation>Christie Hospital NHS, Manchester, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mattila, Leena" sort="Mattila, Leena" uniqKey="Mattila L" first="Leena" last="Mattila">Leena Mattila</name><affiliation><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Aspegren, John" sort="Aspegren, John" uniqKey="Aspegren J" first="John" last="Aspegren">John Aspegren</name><affiliation><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Vuorela, Annamari" sort="Vuorela, Annamari" uniqKey="Vuorela A" first="Annamari" last="Vuorela">Annamari Vuorela</name><affiliation><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Langmuir, Peter" sort="Langmuir, Peter" uniqKey="Langmuir P" first="Peter" last="Langmuir">Peter Langmuir</name><affiliation><nlm:affiliation>Endo Pharmaceuticals, Malvern, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mustonen, Mika" sort="Mustonen, Mika" uniqKey="Mustonen M" first="Mika" last="Mustonen">Mika Mustonen</name><affiliation><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Androgen Receptor Antagonists (pharmacology)</term><term>Confidence Intervals</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Maximum Tolerated Dose</term><term>Middle Aged</term><term>Neoplasm Invasiveness (pathology)</term><term>Neoplasm Metastasis</term><term>Neoplasm Staging</term><term>Patient Safety</term><term>Patient Selection</term><term>Prognosis</term><term>Prostate-Specific Antigen (blood)</term><term>Prostatic Neoplasms, Castration-Resistant (drug therapy)</term><term>Prostatic Neoplasms, Castration-Resistant (mortality)</term><term>Prostatic Neoplasms, Castration-Resistant (pathology)</term><term>Pyrazoles (pharmacology)</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Prostate-Specific Antigen</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Androgen Receptor Antagonists</term><term>Pyrazoles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Neoplasm Invasiveness</term><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Confidence Intervals</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Maximum Tolerated Dose</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Neoplasm Staging</term><term>Patient Safety</term><term>Patient Selection</term><term>Prognosis</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24974051</PMID><DateCreated><Year>2014</Year><Month>08</Month><Day>01</Day></DateCreated><DateCompleted><Year>2014</Year><Month>12</Month><Day>15</Day></DateCompleted><DateRevised><Year>2016</Year><Month>06</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><Issue>9</Issue><PubDate><Year>2014</Year><Month>Aug</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.</ArticleTitle><Pagination><MedlinePgn>975-85</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(14)70240-2</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(14)70240-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The ARADES trial is an open-label phase 1-2 trial undertaken in 23 hospitals across Europe and USA with ongoing long-term follow-up. Men with progressive metastatic castration-resistant prostate cancer, who had castrate concentrations of testosterone and an Eastern Cooperative Oncology Group score of 0-1 were enrolled. In the phase 1 part of the trial, patients were given oral ODM-201 at a starting daily dose of 200 mg, which was increased to 400 mg, 600 mg, 1000 mg, 1400 mg, and 1800 mg. In phase 2, patients were randomly assigned centrally and stratified by previous chemotherapy and treatment with CPY17 inhibitors, to receive one of three daily doses of ODM-201 (200 mg, 400 mg, and 1400 mg). The primary endpoint in phase 1 was safety and tolerability, whereas in phase 2 it was the proportion of patients with a PSA response (50% or greater decrease in serum PSA) at week 12. All analyses included patients who had received at least one dose of ODM-201. This trial is registered with ClinicalTrials.gov, number NCT01317641, and NCT01429064 for the follow-up after 12 weeks.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">We enrolled patients between April 5, 2011, and March 12, 2013. In phase 1, 24 patients were enrolled to six sequential cohorts of three to six patients and received a daily dose of ODM-201, 200-1800 mg. No dose-limiting toxic effects were reported and the maximum tolerated dose was not reached. In phase 1, three patients reported eight adverse events of grade 3 (fracture, muscle injury, laceration, paralytic ileus, pain, presyncope, urinary retention, and vomiting) and one patient had a grade 4 adverse event (lymphoedema). None of the grade 3-4 adverse events were deemed to be related to ODM-201. Of the phase 1 patients, the four who received 200 mg, seven who received 400 mg, and three who received 1400 mg entered the phase 2 part of the trial. In addition to these patients, 110 were randomly assigned to three groups: 200 mg (n=38), 400 mg (n=37), and 1400 mg (n=35). For these patients, the most common treatment-emergent adverse events were fatigue or asthenia (15 [12%] of 124 patients), hot flush (six [5%]), and decreased appetite (five [4%]). One patient (<1%) had a grade 3 treatment-emergent adverse event (fatigue); no patients had a treatment-emergent grade 4 adverse event. 38 patients who received 200 mg, 39 who received 400 mg, and 33 who received 1400 mg were assessable for PSA response at 12 weeks. 11 (29%) patients in the 200 mg group, 13 (33%) in the 400 mg group, and 11 (33%) in the 1400 mg group had a PSA response at 12 weeks.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Our results suggest that ODM-201 monotherapy in men with progressive metastatic castration-resistant prostate cancer provides disease suppression and that ODM-201 has a favourable safety profile. These findings support further investigation of clinical responses with ODM-201 in men with castration-resistant prostate cancer.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Orion Corporation Orion Pharma, Endo Pharmaceuticals Inc.</AbstractText><CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Fizazi</LastName><ForeName>Karim</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: fizazi@igr.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Massard</LastName><ForeName>Christophe</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bono</LastName><ForeName>Petri</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>Robert</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Velindre Cancer Centre, Cardiff, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kataja</LastName><ForeName>Vesa</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Kuopio University Hospital, Kuopio, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>James</LastName><ForeName>Nicholas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Queen Elizabeth Hospital, Birmingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garcia</LastName><ForeName>Jorge A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Protheroe</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Churchill Hospital, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tammela</LastName><ForeName>Teuvo L</ForeName><Initials>TL</Initials><AffiliationInfo><Affiliation>Tampere University Hospital, Tampere, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elliott</LastName><ForeName>Tony</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Christie Hospital NHS, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mattila</LastName><ForeName>Leena</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aspegren</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vuorela</LastName><ForeName>Annamari</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Langmuir</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Endo Pharmaceuticals, Malvern, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mustonen</LastName><ForeName>Mika</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>ARADES study group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01317641</AccessionNumber><AccessionNumber>NCT01429064</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>06</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D059002">Androgen Receptor Antagonists</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C000607739">ORM-16497</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011720">Pyrazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.21.77</RegistryNumber><NameOfSubstance UI="D017430">Prostate-Specific Antigen</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Eur Urol. 2015 Feb;67(2):348-9</RefSource><PMID Version="1">25760250</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Urol. 2014 Aug;11(8):423</RefSource><PMID Version="1">25023597</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Cancer Discov. 2014 Sep;4(9):OF10</RefSource><PMID Version="1">25185192</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Oncol. 2014 Aug;15(9):912-3</RefSource><PMID Version="1">24974052</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059002" MajorTopicYN="N">Androgen Receptor Antagonists</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016001" MajorTopicYN="N">Confidence Intervals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020714" MajorTopicYN="N">Maximum Tolerated Dose</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009361" MajorTopicYN="N">Neoplasm Invasiveness</DescriptorName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009362" MajorTopicYN="N">Neoplasm Metastasis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061214" MajorTopicYN="N">Patient Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018579" MajorTopicYN="N">Patient Selection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017430" MajorTopicYN="N">Prostate-Specific Antigen</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D064129" MajorTopicYN="N">Prostatic Neoplasms, Castration-Resistant</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="Y">mortality</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011720" MajorTopicYN="N">Pyrazoles</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>6</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>6</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>12</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24974051</ArticleId><ArticleId IdType="pii">S1470-2045(14)70240-2</ArticleId><ArticleId IdType="doi">10.1016/S1470-2045(14)70240-2</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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