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ISRCTN
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ISRCTN06890529
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ClinicalTrials.gov identifier
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Public title
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A randomised study about the effect on survival of hormonal therapy versus hormonal therapy plus local external radiation therapy in patients with primary diagnosed metastasised (M+) prostate cancer
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Scientific title
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Acronym
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The HORRAD study
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Serial number at source
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NTR271
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Study hypothesis
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Today the standard therapy for patients primary diagnosed with M+ prostate cancer (bone metastasis) is systemic hormonal therapy. If standard hormonal treatment will be combined with local external radiation therapy of the prostate the survival may improve.
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Lay summary
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Ethics approval
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Received from the local medical ethics committee
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Study design
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Multicentre, randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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1. Histologically proven adenocarcinoma of the prostate
2. Stage T1-4, G1-3, N0-2, M1
3. Bone metastases diagnosed with a bonescan
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Participants - exclusion criteria
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1. Start therapy more than 8 weeks after the initial diagnoses
2. Other treatment for prostate cancer before start of the study therapy
3. Other malignancies except skin carcinoma
4. Prostate specific antigen (PSA) less than 20 ng/ml
5. Aged greater than 80 years
6. Participation in another protocol
7. Not capable of filling out Quality of Life Questionnaires
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Anticipated start date
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01/12/2004
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Anticipated end date
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01/12/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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Group 1 will be hormonally treated with a LHRH analogue
Group 2 will be hormonally treated with a LHRH analogue in combination with local external radiation therapy of the prostate (70 Gray)
Joint sponsor:
Erasmus Medical Centre (The Netherlands)
Department of Urology
P.O. Box 1738
Rotterdam, 3000 RD
The Netherlands
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Primary outcome measure(s)
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Survival
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Secondary outcome measure(s)
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1. Biochemical progression
2. Health related quality of life
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Sources of funding
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AstraZeneca (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
G
van Andel
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Address
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Onze Lieve Vrouwe Gasthuis (OLVG)
Department of Urology
P.O. Box 95500
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City/town
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Amsterdam
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Zip/Postcode
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1090 HM
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Country
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Netherlands
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Email
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g.v.andel@wxs.nl
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Sponsor
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Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
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Address
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Department of Urology
P.O. Box 95500
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City/town
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Amsterdam
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Zip/Postcode
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1090 HM
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Country
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Netherlands
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Tel
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+31 (0)20 599 9111
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Fax
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+31 (0)20 599 3818
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Email
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informatie@olvg.nl
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Sponsor website:
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http://www.olvg.nl/
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Date applied
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20/12/2005
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Last edited
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14/11/2008
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Date ISRCTN assigned
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20/12/2005
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