Generated Narrative: Citation 179626

url: Citation 22056152 Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.

identifier: FEvIR Object Identifier/https://fevir.net/FOI/179626, https://pubmed.ncbi.nlm.nih.gov/22056152, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.21

version: 2.0.0-ballot

title: 22056152 Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.

status: Active

date: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

UseContexts

jurisdiction: World

copyright:

approvalDate: 2012-01-03

lastReviewDate: 2022-03-21

author: Computable Publishing®: MEDLINE-to-FEvIR Converter:

classification

type: Citation Source

classifier: MEDLINE

classification

type: MEDLINE Citation Owner

classifier: National Library of Medicine, Index Section

currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish

statusDate

activity: PubMed Pubstatus of Entrez

period: ?? --> 2011-11-08 06:00:00+0000

statusDate

activity: PubMed Pubstatus of Pubmed

period: ?? --> 2011-11-08 06:00:00+0000

statusDate

activity: PubMed Pubstatus of Medline

period: ?? --> 2012-01-04 06:00:00+0000

statusDate

activity: PubMed Pubstatus of PMC release

period: ?? --> 2011-12-17

citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/22056152, https://www.ncbi.nlm.nih.gov/pmc//PMC3243932, https://doi.org/10.1016/S0140-6736(11)61095-7, pii/S0140-6736(11)61095-7

relatedIdentifier: ISRCTN24991896, https://clinicaltrials.gov/NCT00002633

Titles

-	Type	Language	Text
*	Primary title	English	Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.

Abstracts

-	Text	Copyright
*	BACKGROUND: Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. METHODS: Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. RESULTS: Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0·77, 95% CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade >3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade >3, 14 patients (2·3%) in both groups). INTERPRETATION: The benefits of combined modality treatment--ADT and RT--should be discussed with all patients with locally advanced prostate cancer. FUNDING: Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.	Copyright © 2011 Elsevier Ltd. All rights reserved.

relatesTo

type: cites

classifier: Journal Article

citation:

Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2008;127:2893–2917.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/21351269/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/21351269

relatesTo

type: cites

classifier: Journal Article

citation:

Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010;60:277–300.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20610543/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20610543

relatesTo

type: cites

classifier: Journal Article

citation:

Cooperberg MR, Moul JW, Carroll PR. The changing face of prostate cancer. J Clin Oncol. 2005;23:8146–8151.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/16278465/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/16278465

relatesTo

type: cites

classifier: Journal Article

citation:

Eastham JA, Evans CP, Zietman A. What is the optimal management of high risk, clinically localized prostate cancer? Urol Oncol. 2010;28:557–567.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20816616/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20816616

relatesTo

type: cites

classifier: Journal Article

citation:

Fellows GJ, Clark PB, Beynon LL. Treatment of advanced localised prostatic cancer by orchiectomy, radiotherapy, or combined treatment. A Medical Research Council Study. Urological Cancer Working Party—Subgroup on Prostatic Cancer. Br J Urol. 1992;70:304–309.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/1422689/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/1422689

relatesTo

type: cites

classifier: Journal Article

citation:

Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31:103–115.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/1100130/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/1100130

relatesTo

type: cites

classifier: Journal Article

citation:

Aaronson NK, Ahmedzai S, Bergman B. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–376.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/8433390/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/8433390

relatesTo

type: cites

classifier: Journal Article

citation:

Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997;50:920–928.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/9426724/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/9426724

relatesTo

type: cites

classifier: Journal Article

citation:

Monti AF, Ostinelli A, Frigerio M. An ICRU 50 radiotherapy treatment chart. Radiother Oncol. 1995;35:145–150.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/7569023/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/7569023

relatesTo

type: cites

classifier: Journal Article

citation:

Bolla M, van Tienhoven G, Warde P. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010;11:1066–1073.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20933466/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20933466

relatesTo

type: cites

classifier: Journal Article

citation:

Bolla M, Gonzalez D, Warde P. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997;337:295–300.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/9233866/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/9233866

relatesTo

type: cites

citation:

Gray R. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141–1154.

relatesTo

type: cites

citation:

Lan G, DeMets D. Discrete sequential boundaries for clinical trials. Biometrika. 1983;70:659–663.

relatesTo

type: cites

classifier: Journal Article

citation:

Widmark A, Klepp O, Solberg A. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009;373:301–308.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/19091394/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/19091394

relatesTo

type: cites

classifier: Journal Article

citation:

Cella D, Nichol MB, Eton D, Nelson JB, Mulani P. Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy—prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value Health. 2009;12:124–129.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/18647260/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/18647260

relatesTo

type: cites

classifier: Journal Article

citation:

Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005;41:280–287.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/15661554/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/15661554

relatesTo

type: cites

classifier: Journal Article

citation:

Bolla M, de Reijke TM, van Tienhoven G. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009;360:2516–2527.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/19516032/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/19516032

relatesTo

type: cites

classifier: Journal Article

citation:

Horwitz EM, Bae K, Hanks GE. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008;26:2497–2504.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/18413638/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/18413638

relatesTo

type: cites

classifier: Journal Article

citation:

Alibhai SM, Duong-Hua M, Cheung AM. Fracture types and risk factors in men with prostate cancer on androgen deprivation therapy: a matched cohort study of 19,079 men. J Urol. 2010;184:918–923.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20643458/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20643458

relatesTo

type: cites

classifier: Journal Article

citation:

Alibhai SM, Mohamedali HZ. Cardiac and cognitive effects of androgen deprivation therapy: are they real? Curr Oncol. 2010;17(suppl 2):S55–S64.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20882135/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20882135

relatesTo

type: cites

classifier: Journal Article

citation:

Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006;24:4448–4456.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/16983113/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/16983113

relatesTo

type: cites

classifier: Journal Article

citation:

Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005;352:154–164.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/15647578/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/15647578

relatesTo

type: cites

classifier: Journal Article

citation:

McMullen KP, Lee WR. A structured literature review to determine the use of the American Society for Therapeutic Radiology and Oncology consensus definition of biochemical failure. Urology. 2003;61:391–396.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/12597954/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/12597954

relatesTo

type: cites

classifier: Journal Article

citation:

Kuban DA, Tucker SL, Dong L. Long-term results of the M D Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008;70:67–74.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/17765406/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/17765406

relatesTo

type: cites

classifier: Journal Article

citation:

Zietman AL, DeSilvio ML, Slater JD. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005;294:1233–1239.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/16160131/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/16160131

relatesTo

type: cites

classifier: Journal Article

citation:

Rosenthal SA, Sandler HM. Treatment strategies for high-risk locally advanced prostate cancer. Nat Rev Urol. 2010;7:31–38.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20062072/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20062072

relatesTo

type: cites

classifier: Journal Article

citation:

Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28:1117–1123.

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/20124165/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/20124165

relatesTo

type: comment-in

classifier: Comment

citation:

Lancet. 2011 Dec 17;378(9809):2056-7. doi: 10.1016/S0140-6736(11)61254-3

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/22056154/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/22056154

relatesTo

type: comment-in

classifier: Comment

citation:

Ann Intern Med. 2012 Apr 17;156(8):JC4-05, JC4-04. doi: 10.7326/0003-4819-156-8-201204170-02005

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/22508745/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/22508745

relatesTo

type: comment-in

classifier: Comment

citation:

J Urol. 2012 Sep;188(3):810. doi: 10.1016/j.juro.2012.05.065

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/22883758/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/22883758

relatesTo

type: comment-in

classifier: Comment

citation:

Eur Urol. 2012 Nov;62(5):932-3. doi: 10.1016/j.eururo.2012.08.041

Documents

-	Url
*	https://pubmed.ncbi.nlm.nih.gov/23036346/

resourceReference: Identifier: https://pubmed.ncbi.nlm.nih.gov/23036346

publicationForm

publishedIn

type: Periodical

identifier: Electronic ISSN Type/1474-547X, ISOAbbreviation/Lancet, ISSN Linking/0140-6736, Medline Title Abbreviation/Lancet, NLM Unique ID/2985213R

title: Lancet (London, England)

publisherLocation: England

citedMedium: Internet

volume: 378

issue: 9809

articleDate: 2011-12-17

publicationDateText: 2011-Dec-17

language: English

pageString: 2104-11

publicationForm

citedMedium: Internet without issue

articleDate: 2011-11-02

webLocation

classifier: Abstract

url: https://pubmed.ncbi.nlm.nih.gov/22056152/

webLocation

classifier: DOI Based

url: https://doi.org/10.1016/S0140-6736(11)61095-7

classification

type: Publishing Model

classifier: Print Electronic

classification

type: Chemical

classifier: Androgen Antagonists, Gonadotropin-Releasing Hormone

classification

type: MeSH heading

artifactAssessment: ArtifactAssessment: artifact[x] = this resource

classification

type: Publication type

classifier: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't

classification

type: Knowledge Artifact Type

classifier: Journal Article

artifactAssessment: Classifier added by Computable Publishing LLC

classification

type: Citation subset

classifier: IM

contributorship

complete: true

entry

contributor: Warde P

forenameInitials: P

affiliation: Princess Margaret Hospital, Toronto, Canada. padraig.warde@rmp.uhn.on.ca

entry

contributor: Mason M

forenameInitials: M

entry

contributor: Ding K

forenameInitials: K

entry

contributor: Kirkbride P

forenameInitials: P

entry

contributor: Brundage M

forenameInitials: M

entry

contributor: Cowan R

forenameInitials: R

entry

contributor: Gospodarowicz M

forenameInitials: M

entry

contributor: Sanders K

forenameInitials: K

entry

contributor: Kostashuk E

forenameInitials: E

entry

contributor: Swanson G

forenameInitials: G

entry

contributor: Barber J

forenameInitials: J

entry

contributor: Hiltz A

forenameInitials: A

entry

contributor: Parmar MK

forenameInitials: MK

entry

contributor: Sathya J

forenameInitials: J

entry

contributor: Anderson J

forenameInitials: J

entry

contributor: Hayter C

forenameInitials: C

entry

contributor: Hetherington J

forenameInitials: J

entry

contributor: Sydes MR

forenameInitials: MR

entry

contributor: Parulekar W

forenameInitials: W

entry

contributor: NCIC CTG PR.3/MRC UK PR07 investigators

Generated Narrative: Practitioner #contributor0

name: Padraig Warde

Generated Narrative: Practitioner #contributor1

name: Malcolm Mason

Generated Narrative: Practitioner #contributor2

name: Keyue Ding

Generated Narrative: Practitioner #contributor3

name: Peter Kirkbride

Generated Narrative: Practitioner #contributor4

name: Michael Brundage

Generated Narrative: Practitioner #contributor5

name: Richard Cowan

Generated Narrative: Practitioner #contributor6

name: Mary Gospodarowicz

Generated Narrative: Practitioner #contributor7

name: Karen Sanders

Generated Narrative: Practitioner #contributor8

name: Edmund Kostashuk

Generated Narrative: Practitioner #contributor9

name: Greg Swanson

Generated Narrative: Practitioner #contributor10

name: Jim Barber

Generated Narrative: Practitioner #contributor11

name: Andrea Hiltz

Generated Narrative: Practitioner #contributor12

name: Mahesh K B Parmar

Generated Narrative: Practitioner #contributor13

name: Jinka Sathya

Generated Narrative: Practitioner #contributor14

name: John Anderson

Generated Narrative: Practitioner #contributor15

name: Charles Hayter

Generated Narrative: Practitioner #contributor16

name: John Hetherington

Generated Narrative: Practitioner #contributor17

name: Matthew R Sydes

Generated Narrative: Practitioner #contributor18

name: Wendy Parulekar

Generated Narrative: Organization #contributor19

name: NCIC CTG PR.3/MRC UK PR07 investigators

Generated Narrative: ArtifactAssessment #meshHeading0

artifact: Citation 22056152 Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.

content

type: components (if present) include qualifier codings

classifier: Adenocarcinoma

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: mortality

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: radiotherapy

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: therapy

Components

-	Type	Classifier
*	is Major topic	Yes

content

type: components (if present) include qualifier codings

classifier: Aged, 80 and over

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Androgen Antagonists

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: adverse effects

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: therapeutic use

Components

-	Type	Classifier
*	is Major topic	Yes

content

type: components (if present) include qualifier codings

classifier: Combined Modality Therapy

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Gonadotropin-Releasing Hormone

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: agonists

Components

-	Type	Classifier
*	is Major topic	Yes

content

type: components (if present) include qualifier codings

classifier: Humans

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Male

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Orchiectomy

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Prostatic Neoplasms

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: mortality

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: radiotherapy

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: therapy

Components

-	Type	Classifier
*	is Major topic	Yes

content

type: components (if present) include qualifier codings

classifier: Quality of Life

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

type: components (if present) include qualifier codings

classifier: Radiotherapy

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: adverse effects

Components

-	Type	Classifier
*	is Major topic	No

content

type: components (if present) include qualifier codings

classifier: Survival Rate

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic