A phase III study of neoadjuvant bicalutamide in patients with intermediate risk prostate cancer undergoing radiation therapy

ISRCTN ISRCTN64733264
DOI https://doi.org/10.1186/ISRCTN64733264
Secondary identifying numbers 99-07
Submission date
27/10/2004
Registration date
25/01/2005
Last edited
18/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Padraig Warde
Scientific

610 University Avenue
Toronto
M5G 2M9
Canada

Phone +1 416 946 2122
Email padraig.warde@rmp.uhn.on.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLocalised prostate cancer
InterventionBicalutamide 150 mg daily for 3 months before and 2 months during radiation therapy versus no hormonal therapy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bicalutamide
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/1999
Completion date30/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants360
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/07/1999
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

610 University Avenue
Toronto
M5G 2M9
Canada

Sponsor information

Princess Margaret Hospital (Canada) - Department of Radiation Oncology
Hospital/treatment centre

610 University Avenue
Toronto
M5G 2M9
Canada

ROR logo "ROR" https://ror.org/03zayce58

Funders

Funder type

Hospital/treatment centre

Princess Margaret Hospital (Canada) - internal genitourinary (GU) group funds

No information available

AstraZeneca (Canada) - small unrestricted grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan