Phase II study of the human anti-epithelial cell adhesion molecule antibody adecatumumab in prostate cancer patients with increasing serum levels of prostate-specific antigen after radical prostatectomy.

摘要: Background: Rising serum levels of prostate-specific antigen (PSA) after radical prostatectomy are indicative recurrent prostate cancer. This double-blind, placebo-controlled phase II study evaluated the anti-tumour activity anti-epithelial cell adhesion molecule (EpCAM) antibody adecatumumab in delaying biochemical disease progression. Patients and Methods: Prostate cancer patients with increasing PSA following were randomized to low- (2 mg/kg) or high-dose (6 placebo. The primary efficacy endpoint was mean change from baseline total at week 24. Secondary endpoints included response rate, prolongation doubling time Results: secondary not met predefined analyses. In a retrospective analysis <= 1 ng/ml high EpCAM expression, both increase 24 15 significantly improved group compared placebo group. Most frequent treatment-related clinical adverse events gastrointestinal (diarrhoea nausea) general (chills), showing dose dependency but no grade 3/4 intensity any patient. Conclusion: men rising evidence relapse, delayed progression subgroup EpCAM-expressing tumours. Copyright (C) 2010 S. Karger AG, Basel (Less)