Validation and clinical utility of prostate cancer biomarkers Journal Article
| Authors: | Scher, H. I.; Morris, M. J.; Larson, S.; Heller, G. |
| Article Title: | Validation and clinical utility of prostate cancer biomarkers |
| Abstract: | To improve future drug development and patient management for patients with castration-resistant prostate cancer (CRPC), surrogate biomarkers that are linked to relevant outcomes are urgently needed. A biomarker must be measurable, reproducible, linked to relevant clinical outcomes, and demonstrate clinical utility. This area is rapidly evolving, with recent trials in patients with CRPC incorporating the detection of circulating tumour cells (CTCs), imaging, and patient-reported outcome biomarkers. We discuss the framework for the development of biomarkers for CRPC, including different categories and contexts of use. We also highlight the requirements of analytical validation, the sequence of trials needed for clinical validation and regulatory approval, and the future outlook for imaging and CTC biomarkers. ©2013 Macmillan Publishers Limited. All rights reserved. |
| Keywords: | cancer survival; unclassified drug; overall survival; review; placebo; drug efficacy; validation process; bone metastasis; disease marker; positron emission tomography; antineoplastic agent; medical decision making; reproducibility; prostate specific antigen; vasculotropin receptor; progression free survival; quality of life; tumor volume; tumor markers, biological; hemoglobin; cancer pain; tumor regression; diagnostic imaging; cell assay; tumor marker; cancer mortality; docetaxel; gleason score; prostatic neoplasms; diagnostic value; drug response; phosphatidylinositol 3,4,5 trisphosphate 3 phosphatase; fluorodeoxyglucose f 18; radiopharmaceutical agent; androgen receptor; lactate dehydrogenase; clinical effectiveness; abiraterone acetate; castration; validation studies as topic; analgesia; b raf kinase; bone scintiscanning; zoledronic acid; transcription factor ets; circulating tumor cell; castration resistant prostate cancer; cost utility analysis; denosumab; radiological parameters; radium 223; brief pain inventory; scintillation camera; custirsen; cabazitaxel; lexidronam samarium sm 153; strontium 89; fluorodihydrotestosterone f 18; sipuleucel t; laboratory automation; cancer prognosis; cabozantinib; bone scan index; enzalutamide |
| Journal Title: | Nature Reviews Clinical Oncology |
| Volume: | 10 |
| Issue: | 4 |
| ISSN: | 1759-4774 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2013-04-01 |
| Start Page: | 225 |
| End Page: | 234 |
| Language: | English |
| PROVIDER: | scopus |
| PUBMED: | 23459624 |
| DOI: | 10.1038/nrclinonc.2013.30 |
| PMCID: | PMC3790270 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 1 May 2013" - ":doi 10.1038/nrclinonc.2013.30" - "Source: Scopus" |
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