Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy

To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure

Inclusion Criteria:

• Relapsed prostate cancer after prostatectomy or radiotherapy
• PSA levels below 10 ng/mL
• Lymph node negative
• Metastasis negative
• Withdrawal of hormone therapy at least 6 months before entry into the study
• Written informed consent

Exclusion Criteria:

• Metastatic disease
• Hormonal treatment 6 months before study entry
• Concomitant radiotherapy, surgery and/or chemotherapy
• ILD