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Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302.

Identifieur interne : 002913 ( PubMed/Corpus ); précédent : 002912; suivant : 002914

Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302.

Auteurs : Fred Saad ; Neal Shore ; Hendrik Van Poppel ; Dana E. Rathkopf ; Matthew R. Smith ; Johann S. De Bono ; Christopher J. Logothetis ; Paul De Souza ; Karim Fizazi ; Peter F A. Mulders ; Paul Mainwaring ; John D. Hainsworth ; Tomasz M. Beer ; Scott North ; Yves Fradet ; Thomas A. Griffin ; Peter De Porre ; Anil Londhe ; Thian Kheoh ; Eric J. Small ; Howard I. Scher ; Arturo Molina ; Charles J. Ryan

Source :

RBID : pubmed:25985882

English descriptors

Abstract

Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.

DOI: 10.1016/j.eururo.2015.04.032
PubMed: 25985882

Links to Exploration step

pubmed:25985882

Le document en format XML

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<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<nlm:affiliation>University of Montréal, Montréal, Québec, Canada. Electronic address: fredsaad@videotron.ca.</nlm:affiliation>
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<author>
<name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name>
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<nlm:affiliation>Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA.</nlm:affiliation>
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<name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name>
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<nlm:affiliation>University Hospital Leuven, Leuven, Belgium.</nlm:affiliation>
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<name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E" last="Rathkopf">Dana E. Rathkopf</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
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<name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R" last="Smith">Matthew R. Smith</name>
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<nlm:affiliation>Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.</nlm:affiliation>
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<name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S" last="De Bono">Johann S. De Bono</name>
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<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J" last="Logothetis">Christopher J. Logothetis</name>
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<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<nlm:affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</nlm:affiliation>
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<name sortKey="Mulders, Peter F A" sort="Mulders, Peter F A" uniqKey="Mulders P" first="Peter F A" last="Mulders">Peter F A. Mulders</name>
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<nlm:affiliation>Radboud University Medical Centre, Nijmegen, The Netherlands.</nlm:affiliation>
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<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
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<nlm:affiliation>Hematology and Oncology Clinics of Australia, Brisbane, Australia.</nlm:affiliation>
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<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D" last="Hainsworth">John D. Hainsworth</name>
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<nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation>
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<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
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<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
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<nlm:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada.</nlm:affiliation>
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<name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
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<nlm:affiliation>Laval University, Québec City, Québec, Canada.</nlm:affiliation>
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<name sortKey="Griffin, Thomas A" sort="Griffin, Thomas A" uniqKey="Griffin T" first="Thomas A" last="Griffin">Thomas A. Griffin</name>
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<name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name>
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<name sortKey="Londhe, Anil" sort="Londhe, Anil" uniqKey="Londhe A" first="Anil" last="Londhe">Anil Londhe</name>
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<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
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<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J" last="Small">Eric J. Small</name>
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<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I" last="Scher">Howard I. Scher</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
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<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
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<nlm:affiliation>Janssen Research & Development, Menlo Park, CA, USA.</nlm:affiliation>
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<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
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<nlm:affiliation>Hematology and Oncology Clinics of Australia, Brisbane, Australia.</nlm:affiliation>
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<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D" last="Hainsworth">John D. Hainsworth</name>
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<nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation>
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<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
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<nlm:affiliation>Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA.</nlm:affiliation>
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<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
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<nlm:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada.</nlm:affiliation>
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<name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
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<name sortKey="Griffin, Thomas A" sort="Griffin, Thomas A" uniqKey="Griffin T" first="Thomas A" last="Griffin">Thomas A. Griffin</name>
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<nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
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<name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name>
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<nlm:affiliation>Janssen Research & Development, Beerse, Belgium.</nlm:affiliation>
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<name sortKey="Londhe, Anil" sort="Londhe, Anil" uniqKey="Londhe A" first="Anil" last="Londhe">Anil Londhe</name>
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<nlm:affiliation>Janssen Research & Development, Raritan, NJ, USA.</nlm:affiliation>
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<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
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<nlm:affiliation>Janssen Research & Development, San Diego, CA, USA.</nlm:affiliation>
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<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J" last="Small">Eric J. Small</name>
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<nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation>
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<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I" last="Scher">Howard I. Scher</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
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<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
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<nlm:affiliation>Janssen Research & Development, Menlo Park, CA, USA.</nlm:affiliation>
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<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J" last="Ryan">Charles J. Ryan</name>
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<nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation>
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<term>Abiraterone Acetate (adverse effects)</term>
<term>Abiraterone Acetate (therapeutic use)</term>
<term>Aged</term>
<term>Antineoplastic Agents, Hormonal (adverse effects)</term>
<term>Antineoplastic Agents, Hormonal (therapeutic use)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Bisphosphonate-Associated Osteonecrosis of the Jaw (etiology)</term>
<term>Bone Density Conservation Agents (adverse effects)</term>
<term>Bone Density Conservation Agents (therapeutic use)</term>
<term>Bone Neoplasms (drug therapy)</term>
<term>Bone Neoplasms (mortality)</term>
<term>Bone Neoplasms (secondary)</term>
<term>Clinical Trials, Phase III as Topic</term>
<term>Disease-Free Survival</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multicenter Studies as Topic</term>
<term>Odds Ratio</term>
<term>Prednisone (therapeutic use)</term>
<term>Proportional Hazards Models</term>
<term>Prostatic Neoplasms, Castration-Resistant (drug therapy)</term>
<term>Prostatic Neoplasms, Castration-Resistant (mortality)</term>
<term>Prostatic Neoplasms, Castration-Resistant (pathology)</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Retrospective Studies</term>
<term>Risk Factors</term>
<term>Steroid Synthesis Inhibitors (adverse effects)</term>
<term>Steroid Synthesis Inhibitors (therapeutic use)</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
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<term>Abiraterone Acetate</term>
<term>Antineoplastic Agents, Hormonal</term>
<term>Bone Density Conservation Agents</term>
<term>Steroid Synthesis Inhibitors</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Abiraterone Acetate</term>
<term>Antineoplastic Agents, Hormonal</term>
<term>Bone Density Conservation Agents</term>
<term>Prednisone</term>
<term>Steroid Synthesis Inhibitors</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Bone Neoplasms</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en">
<term>Bisphosphonate-Associated Osteonecrosis of the Jaw</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en">
<term>Bone Neoplasms</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
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<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Prostatic Neoplasms, Castration-Resistant</term>
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<term>Bone Neoplasms</term>
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<term>Antineoplastic Combined Chemotherapy Protocols</term>
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<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Clinical Trials, Phase III as Topic</term>
<term>Disease-Free Survival</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
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<term>Middle Aged</term>
<term>Multicenter Studies as Topic</term>
<term>Odds Ratio</term>
<term>Proportional Hazards Models</term>
<term>Randomized Controlled Trials as Topic</term>
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<front>
<div type="abstract" xml:lang="en">Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.</div>
</front>
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<PMID Version="1">25985882</PMID>
<DateCreated>
<Year>2015</Year>
<Month>09</Month>
<Day>04</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>06</Month>
<Day>08</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>09</Month>
<Day>30</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1873-7560</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>68</Volume>
<Issue>4</Issue>
<PubDate>
<Year>2015</Year>
<Month>Oct</Month>
</PubDate>
</JournalIssue>
<Title>European urology</Title>
<ISOAbbreviation>Eur. Urol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302.</ArticleTitle>
<Pagination>
<MedlinePgn>570-7</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eururo.2015.04.032</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0302-2838(15)00374-7</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial.</AbstractText>
<AbstractText Label="INTERVENTION" NlmCategory="METHODS">Patients were grouped by concomitant BTT use or no BTT use.</AbstractText>
<AbstractText Label="OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS" NlmCategory="METHODS">Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models.</AbstractText>
<AbstractText Label="RESULTS AND LIMITATIONS" NlmCategory="CONCLUSIONS">While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p=0.01) and increased the time to ECOG deterioration (HR 0.75; p<0.001) and time to opiate use for cancer-related pain (HR 0.80; p=0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT.</AbstractText>
<AbstractText Label="PATIENT SUMMARY" NlmCategory="RESULTS">Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov NCT00887198.</AbstractText>
<CopyrightInformation>Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Saad</LastName>
<ForeName>Fred</ForeName>
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