Condition category
Cancer
Date applied
27/10/2004
Date assigned
25/01/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Princess Margaret Hospital (Canada) - Department of Radiation Oncology

Sponsor details

610 University Avenue
Toronto
M5G 2M9
Canada

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes