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Biomarkers in the Management and Treatment of Men with Metastatic Castration-Resistant Prostate Cancer

Andrew J. Armstrong, Mario A. Eisenberger, Susan Halabi, Stephane Oudard, David M. Nanus, Daniel P. Petrylak, A. Oliver Sartor and Howard I. Scher

European Urology, Volume 61, Issue 3, Pages 549-559, March 2012

Accepted 3 November 2011, Published online 14-02-2012


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Abstract

Context

We have recently witnessed a rapid increase in the number of effective systemic agents for men with metastatic castration-resistant prostate cancer (CRPC), including novel hormonal therapies (abiraterone acetate and MDV3100), immunotherapies (sipuleucel-T), chemotherapies (cabazitaxel), and bone microenvironment targeting agents (denosumab, radium 223). Given the increasing complexity of treatment decisions for this disease, major research and clinical priorities are (1) finding biomarkers that enable an understanding of the natural history and complex biology of this heterogeneous malignancy, (2) defining predictive biomarkers that identify men most likely to benefit from a given therapy, and (3) identifying biomarkers of early response or progression to optimize outcomes.

Objective

In this review, we discuss existing and potential biomarkers in CRPC and how they may currently inform prognosis, aid in treatment selection (predictive value), and relate to survival outcomes (surrogacy).

Evidence acquisition

PubMed-based literature searches and abstracts through September 2011 provided the basis for this literature review as well as expert opinion.

Evidence synthesis

We address blood and urine-based biomarkers such as prostate-specific antigen, lactate dehydrogenase, total and bone alkaline phosphatase and other bone turnover markers, hemoglobin, and circulating tumor cells in the context of prognosis, prediction, and patient selection for therapy. Given the inherent problems associated with defining progression-free survival in CRPC, the importance of biomarker development and the needed steps are highlighted. We place the discussion of biomarkers within the context of the design/intent of a trial and mechanism of action of a given systemic therapy. We discuss novel biomarker development and the pathway for surrogate or predictive biomarkers to become credentialed as useful tests that inform therapeutic decisions.

Conclusions

A greater understanding of biomarkers in CRPC permits a more personalized approach to care that maximizes benefit and minimizes harm and can inform clinical trials tailored to men most likely to derive benefit.

Take Home Message

We have discussed a range of biomarkers in research and clinical use in men with castration-resistant prostate cancer. If successfully identified, predictive and surrogate biomarkers should accelerate drug development and speed delivery of clinical benefit to the patient while minimizing harm.

Keywords: Castration-resistant prostate cancer, Biomarkers, Prognosis, Surrogate, Circulating tumor cells, PSA, Bone turnover markers, Progression-free survival.


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