Orchiectomy versus goserelin and flutamide in the treatment of newly diagnosed metastatic prostate cancer. Analysis of the criteria of evaluation used in the european organization for research and treatment of cancer–-genitourinary group study 30853

This European Organization for Research and Treatment of Cancer (EORTC) trial 30853 is the fifth EORTC--Genitourinary Group randomized phase III trial of endocrine treatment for patients with newly diagnosed metastatic prostate cancer. Special attention was given to the assessment of response and/or progression. Each of the following factors was assessed separately as nonspecific and subjective criteria of response or progression: performance status, pain, alkaline and acid phosphatase, hemoglobin, urinary symptoms, and prostate-specific antigen (PSA). Objective progression was based on measurable disease. The observed sequence of progression was: (1) protein-specific antigen; (2) bone; (3) pain; and (4) performance status. Protein-specific antigen, an optional parameter, was the first sign of progression in more than 50% of patients whose disease had progressed.