Multicenter Clinical Trials Made Easy
The Prostate Cancer Clinical Trials Consortium (PCCTC) is a 13-member clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program (PCRP) that offers simplified solutions for multicenter clinical trials. Capitalizing on their scientific and clinical expertise and unique institutional resources, PCCTC members collaborate to design, implement and complete phase I and phase II trials in prostate cancer to rapidly bring scientific discoveries to patients.
On May15, 2013, the U. S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with [...]
Genomic Health, Inc. announced the launch of its Oncotype DX® prostate cancer test which can differentiate low-risk and aggressive tumors with up to 95% accuracy. Applied to prostate needle biopsy samples, the test examines an individual patient’s 17 gene “signature”. The resulting Genomic Prostate Score (GPS), used in combination with a patient’s clinical characteristics, can [...]
On December 10, 2012, the U. S. Food and Drug Administration (FDA) approved an expanded indication for abiraterone acetate (Zytiga Tablets, Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who had not received cytotoxic chemotherapy. The drug was approved in 2011 for men with mCRPC who [...]
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval to XTANDI® (enzalutamide; formally known as MDV3100) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor. The FDA accepted the XTANDI New Drug Application [...]