Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.

The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.

Inclusion Criteria:

• Histologically confirmed prostate cancer
• Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

Exclusion Criteria:

• Age > 75 yrs
• No metastatic disease (M1).
• No presence of gynaecomastia and/or mastalgia at screening
• No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.