ASCO publishes prostate cancer biomarker guideline

A clinical practice guideline developed by an American Society of Clinical Oncology (ASCO) multidisciplinary expert panel provides recommendations on the use of molecular biomarker tests to guide management decisions for men with localized prostate cancer.

Published in the Journal of Clinical Oncology (Dec. 12, 2019 [Epub ahead of print]), the systematic review-based guideline was developed to consider the potential role of commercially available molecular biomarkers in the following areas: identifying patients likely to benefit from active surveillance, diagnosing clinically significant prostate cancer (cancer with the potential to ultimately cause symptoms or metastasize), and guiding the decision between postprostatectomy adjuvant or versus salvage radiation therapy. It also assessed the relative strengths and weakness of the genomics testing and magnetic resonance imaging (MRI) for identifying clinically significant prostate cancer.

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Scott E. Eggener, MD, of the University of Chicago Medicine, Chicago, served as co-chair for the ASCO Guideline Expert Panel. Discussing the guideline with Urology Times, he said, “To my knowledge, this is the first sanctioned guideline from a national organization that addresses the role of molecular biomarker testing for localized prostate cancer. The guideline strongly discourages routine reflexive testing because the tests are expensive, have not been prospectively tested or shown to improve long-term outcomes, and the information provided will not directly influence patient decision making or the treatment plan for the majority of patients.”

He continued, “The guideline, however, identifies a select group of men, represented by those with higher-risk features for progression, for whom the biomarker testing may provide information that can be helpful when considered along with routine clinical factors to inform their choice between active surveillance and treatment.”

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The expert panel was comprised of 12 members with expertise in urology, oncology, pathology, and laboratory medicine, and research methodology, and it also included one patient representative. The guideline development process began with a PubMed search that identified 555 studies of localized prostate cancer biomarker published between January 2013 and January 2019. The recommendations were developed based on 77 of those articles plus 32 additional references. The references described results for four commercially available tissue-based biomarker tests: Oncotype DX Prostate, Prolaris, Decipher, and ProMark.

The expert panel did not endorse any specific biomarker test(s) over others, noting the absence of sufficient rigorously designed head-to-head studies.

Regarding the question of relative value of the genomic tests compared with MRI, the expert panel observed the lack of sufficient data to support a consensus statement. They concluded that both modalities could provide clinically relevant information about the likelihood of upgrading on subsequent biopsy or at prostatectomy and may each provide independent and actionable information for specific patients.

The clinical practice guideline recommendations were developed to provide guidance for physicians who care for men with localized prostate cancer as well as other health care practitioners, patients, and caregivers.