Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-17 |
Resource Citation "179630" Version "1" Updated "2023-11-26 22:35:30+0000"
StructureDefinition Work Group: cds
url: https://fevir.net/resources/Citation/179630
identifier: FEvIR Object Identifier: 179630, id: 26092557
version: 1.0.0-ballot
title: 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.
status: active
date: 2023-12-17 16:55:23+0000
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
| Code | Value[x] |
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jurisdiction: World (m49.htm#001)
copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/
approvalDate: 2016-04-14
lastReviewDate: 2022-01-29
author: Computable Publishing®: MEDLINE-to-FEvIR Converter:
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type: Citation Source (Citation Classification Type#citation-source)
classifier: MEDLINE ()
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type: MEDLINE Citation Owner (Citation Classification Type#medline-owner)
classifier: National Library of Medicine, Index Section (elements_descriptions.html#owner_value#NLM)
currentState: Medline Citation Status of Medline (Citation Status Type#medline-medline), PubMed PublicationStatus of ppublish (Citation Status Type#pubmed-publication-status-ppublish)
statusDate
activity: PubMed Pubstatus of Received (Citation Status Type#pubmed-pubstatus-received)
period: ?? --> 2015-02-20
statusDate
activity: PubMed Pubstatus of Revised (Citation Status Type#pubmed-pubstatus-revised)
period: ?? --> 2015-05-08
statusDate
activity: PubMed Pubstatus of Accepted (Citation Status Type#pubmed-pubstatus-accepted)
period: ?? --> 2015-05-11
statusDate
activity: PubMed Pubstatus of Entrez (Citation Status Type#pubmed-pubstatus-entrez)
period: ?? --> 2015-06-21 06:00:00+0000
statusDate
activity: PubMed Pubstatus of Pubmed (Citation Status Type#pubmed-pubstatus-pubmed)
period: ?? --> 2015-06-21 06:00:00+0000
statusDate
activity: PubMed Pubstatus of Medline (Citation Status Type#pubmed-pubstatus-medline)
period: ?? --> 2016-04-15 06:00:00+0000
citedArtifact
identifier: id: 26092557, id: 10.1016/j.urolonc.2015.05.012, pii: S1078-1439(15)00235-5
Titles
Type Language Text Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer. Abstracts
Text Copyright **BACKGROUND AND OBJECTIVE:** Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies. **PATIENTS AND METHODS:** We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling. **RESULTS:** Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms. **CONCLUSIONS:** Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies. Copyright © 2015 Elsevier Inc. All rights reserved. publicationForm
PublishedIns
Type Identifier Title PublisherLocation Periodical (Published In Type#D020492) Electronic ISSN Type: 1873-2496, ISOAbbreviation: Urol Oncol, ISSN Linking: 1078-1439, Medline Title Abbreviation: Urol Oncol, NLM Unique ID: 9805460 Urologic oncology United States citedMedium: Internet (Cited Medium#internet)
volume: 33
issue: 8
articleDate: 2015-08
publicationDateText: 2015-Aug
language: English (Tags for the Identification of Languages#en)
pageString: 337.e1-6
publicationForm
citedMedium: Internet without issue (Cited Medium#internet-without-issue)
articleDate: 2015-06-16
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type: Publishing Model (Cited Artifact Classification Type#publishing-model)
classifier: Print Electronic (Citation Artifact Classifier#Print-Electronic)
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type: Keyword (Cited Artifact Classification Type#keyword)
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content
classifier: Androgen deprivation therapy ()
content
classifier: Docetaxel ()
content
classifier: Prostate cancer ()
content
classifier: Prostatic biopsy ()
classification
type: Chemical (Cited Artifact Classification Type#chemical)
classifier: Androgen Antagonists (#D000726), Taxoids (#D043823), Docetaxel (chemical-substances#15H5577CQD; #D000077143)
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freeToShare: true
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Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Androgen Antagonists (#D000726)
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type: qualifier ()
classifier: administration & dosage (#Q000008)
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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Biopsy (#D001706)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Docetaxel (#D000077143)
freeToShare: true
Components
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informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Feasibility Studies (#D005240)
freeToShare: true
Components
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informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Humans (#D006801)
freeToShare: true
Components
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informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Male (#D008297)
freeToShare: true
Components
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informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Middle Aged (#D008875)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Prostatic Neoplasms (#D011471)
freeToShare: true
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classifier: Clinical Trial, Phase II (#D017427), Journal Article (#D016428), Randomized Controlled Trial (#D016449), Research Support, Non-U.S. Gov't (#D013485)
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contributorship
complete: true
entry
name: Prabhakar Rajan
forenameInitials: P
affiliation: : Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.
entry
name: John A Frew
forenameInitials: JA
affiliation: : Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: James M Wilson
forenameInitials: JM
affiliation: : Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Ashraf S T Azzabi
forenameInitials: AS
affiliation: : Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Rhona M McMenemin
forenameInitials: RM
affiliation: : Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Jacqueline Stockley
forenameInitials: J
affiliation: : Institute of Cancer Sciences, University of Glasgow, UK.
entry
name: Naeem A Soomro
forenameInitials: NA
affiliation: : Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Garrett Durkan
forenameInitials: G
affiliation: : Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Ian D Pedley
forenameInitials: ID
affiliation: : Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry
name: Hing Y Leung
forenameInitials: HY
affiliation: : Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.
Generated Narrative: ArtifactAssessment #keywords0
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content
classifier: Androgen deprivation therapy ()
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classifier: Docetaxel ()
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classifier: Prostate cancer ()
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classifier: Prostatic biopsy ()
Generated Narrative: Practitioner #author0
name: Prabhakar Rajan
Generated Narrative: Practitioner #author1
name: John A Frew
Generated Narrative: Practitioner #author2
name: James M Wilson
Generated Narrative: Practitioner #author3
name: Ashraf S T Azzabi
Generated Narrative: Practitioner #author4
name: Rhona M McMenemin
Generated Narrative: Practitioner #author5
name: Jacqueline Stockley
Generated Narrative: Practitioner #author6
name: Naeem A Soomro
Generated Narrative: Practitioner #author7
name: Garrett Durkan
Generated Narrative: Practitioner #author8
name: Ian D Pedley
Generated Narrative: Practitioner #author9
name: Hing Y Leung
Generated Narrative: ArtifactAssessment #meshHeading0
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Components
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Components
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IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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