Status:
ACTIVE_NOT_RECRUITING
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone
Lead Sponsor:
Abdenour Nabid
Collaborating Sponsors:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy ...
Eligibility Criteria
Inclusion
- Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
- Performance status score of 0-1
- Patients must sign a consent form before starting the study.
- No evidence of regional disease
- Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
- Non-invasive epidermoid cancers of the skin are eligible.
- The patient must be available for treatments and follow-up visits.
- No evidence of metastatic disease, confirmed by a negative bone scan.
Exclusion
- Severe medical or psychiatric problems that may compromise study compliance
- Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase \> 1.5 times the upper normal limit.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00223145
Start Date
December 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