Status:
COMPLETED
Casodex - Nolvadex Combination
Lead Sponsor:
AstraZeneca
Conditions:
Gynaecomastia
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the st...
Eligibility Criteria
Inclusion
- Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
- Subjects in need of immediate hormonal therapy.
- PSA equal or above 4 ng/ml
Exclusion
- Presence of gynaecomastia and/or breast pain at screening visit
- Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
- Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
- Previous mastectomy or radiation to chest wall
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00637871
Start Date
November 1 2002
End Date
August 1 2005
Last Update
January 24 2011
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