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 |
| Protocol serial number | 99-07 |
| Sponsor | Princess Margaret Hospital (Canada) - Department of Radiation Oncology |
| Funders | Princess Margaret Hospital (Canada) - internal genitourinary (GU) group funds, AstraZeneca (Canada) - small unrestricted grant |
- 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
Scientific
610 University Avenue
Toronto
M5G 2M9
Canada
| Phone | +1 416 946 2122 |
|---|---|
| padraig.warde@rmp.uhn.on.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Bicalutamide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 360 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/1999 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
610 University Avenue
Toronto
M5G 2M9
Canada
M5G 2M9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
