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ISRCTN
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ISRCTN64733264
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ClinicalTrials.gov identifier
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Public title
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A phase III study of neoadjuvant bicalutamide in patients with intermediate risk prostate cancer undergoing radiation therapy
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Scientific title
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Acronym
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N/A
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Serial number at source
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99-07
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Localised prostate cancer
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Participants - inclusion criteria
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1. T1/T2a prostate cancer with:
1.1. Gleason 7, prostate specific antigen (PSA) less than 20 ng/ml
1.2. Gleason less than 7, PSA 10 - 20 ng/ml
2. T2b prostate cancer with:
2.1. PSA less than 20 ng/ml
2.2. Gleason less than or equal to 7
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1999
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Anticipated end date
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30/06/2006
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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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360
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Interventions
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Bicalutamide 150 mg daily for 3 months before and 2 months during radiation therapy versus no hormonal therapy.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Princess Margaret Hospital (Canada) - internal genitourinary (GU) group funds
2. AstraZeneca (Canada) - small unrestricted grant
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Trial website
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Publications
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Contact name
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Dr
Padraig
Warde
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Address
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610 University Avenue
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City/town
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Toronto
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Zip/Postcode
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M5G 2M9
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Country
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Canada
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Tel
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+1 416 946 2122
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Fax
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+1 416 946 4586
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Email
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padraig.warde@rmp.uhn.on.ca
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Sponsor
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Princess Margaret Hospital (Canada) - Department of Radiation Oncology
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Address
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610 University Avenue
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City/town
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Toronto
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Zip/Postcode
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M5G 2M9
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Country
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Canada
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Date applied
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27/10/2004
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Last edited
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18/02/2008
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Date ISRCTN assigned
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25/01/2005
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