Casodex - Nolvadex Combination

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Male

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 study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bicalutamide; Tamoxifen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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