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©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Jun 26, 2014; 4(2): 123-132
Published online Jun 26, 2014. doi: 10.5662/wjm.v4.i2.123
Published online Jun 26, 2014. doi: 10.5662/wjm.v4.i2.123
End points of clinical trials in metastatic castration-resistant prostate cancer: A systematic review
Giuseppe Colloca, Antonella Venturino, Division of Medical Oncology, “Giovanni Borea” Hospital, I-18038 Sanremo, Italy
Ilaria Governato, Division of Medical Oncology, Santo Spirito Hospital, 00186 Roma, Italy
Author contributions: Colloca G contributed to the conception and design, acquisition and analysis of data, and preparation of the article; Venturino A contributed to the collection and interpretation of data, critical review and discussion; Governato I contributed to the acquisition and analysis of selected studies and preparation of the article; all authors approved the final version.
Correspondence to: Dr. Giuseppe Colloca, MD, Division of Medical Oncology, “Giovanni Borea” Hospital, Via Giovanni Borea 56, I-18038 Sanremo, Italy. g.colloca@katamail.com
Telephone: +39-184-536403 Fax: +39-184-536390
Received: November 14, 2013
Revised: January 19, 2014
Accepted: March 17, 2014
Published online: June 26, 2014
Revised: January 19, 2014
Accepted: March 17, 2014
Published online: June 26, 2014
Core Tip
Core tip: The approval in the last decade of new drugs that have increased survival of patients with metastatic castration-resistant prostate cancer (mCRPC) has weakened the role of overall survival (OS) as end point. The prevailing bone-only spread of mCRPC severely limits disease evaluation using the standard criteria of conventional radiology. On the other hand, recent retrospective analyses of prostate-specific antigen response after chemotherapy did not support this measure as a surrogate end point of OS. This lack of reliable surrogate end points is a problem for the conduction of phase II studies which test the activity of new drugs.