Contact information
Type
Scientific
Primary contact
Dr Padraig Warde
ORCID ID
Contact details
610 University Avenue
Toronto
M5G 2M9
Canada
+1 416 946 2122
padraig.warde@rmp.uhn.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
99-07
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Localised prostate cancer
Intervention
Bicalutamide 150 mg daily for 3 months before and 2 months during radiation therapy versus no hormonal therapy.
Intervention type
Drug
Phase
Not Specified
Drug names
Bicalutamide
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1999
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
360
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/1999
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Canada
Trial participating centre
610 University Avenue
Toronto
M5G 2M9
Canada
Funders
Funder type
Hospital/treatment centre
Funder name
Princess Margaret Hospital (Canada) - internal genitourinary (GU) group funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca (Canada) - small unrestricted grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary