Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Inclusion Criteria:

• Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
• PSA below 20 ng/mL
• Lymph node negative
• Non-metastatic
• Written informed consent

Exclusion Criteria:

• Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
• Distant or nodal metastases
• Prostatectomy
• Concomitant LHRH analog treatment
• Previous or concomitant anti-androgens
• Active ILD