Status:
ACTIVE_NOT_RECRUITING
Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : n...
Eligibility Criteria
Inclusion
- To have at least one of the following three risk factors:
- Tumour classified T3 or T4
- Gleason score 8-10
- Prostate-specific antigen (PSA) level \> 20
- Performance status score of 0-1.
- Patients must sign a consent form before the start of the study.
- No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography \[CAT\] scan, magnetic resonance imaging \[MRI\], lymphography) or surgical staging or negative pelvic node dissection.
- No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization.
- Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
- Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
- The patient must be available for treatments and follow-up visits.
- Treatments must start in the three weeks following randomization.
Exclusion
- Severe medical or psychiatric problems that could compromise study compliance.
- Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase \> 1.5 times the upper normal limit.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00223171
Start Date
October 1 2000
End Date
December 31 2027
Last Update
January 27 2025
Active Locations (1)
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1
Centre de Recherche Clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4