Molecular Biomarkers in Localized Prostate Cancer

Publication Date: December 12, 2019

Introduction

Introduction

Prostate cancer is the most commonly diagnosed cancer in men in the United States (~174,650 in 2019), nearly 20% of all new cancers, and the second leading cause of cancer-related death (~31,620 in 2019).

At diagnosis, there is a diverse spectrum of clinical course ranging from indolent features with a negligible likelihood of morbidity or mortality to characteristics reflecting near certitude of eventual metastases and cancer-specific death.

Predicting future clinical behavior is imperfect but constitutes the foundation of physician counseling and patient management decisions.
A variety of molecular biomarkers have been developed, evaluated, and commercialized with an overarching aim to further personalize risk stratification, more comprehensively inform management decisions, and consequently improve quality of care.

Table 1. Definitions and Terms

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Molecular biomarker A biological molecule found in blood, body fluid or tissue that provides information regarding presence or absence of a disease, prognosis, or likelihood to respond to a specific treatment. Molecular biomarkers broadly encompass DNA, transcriptome, protein, metabolic, and other tissue-based or cellular biomarkers
Cellular biomarker Cells found in blood, body fluid or tissue that provide information regarding presence or absence of a disease, prognosis, or likelihood to respond to a specific treatment
Genomic biomarker Genetic material (including DNA or RNA) found in blood, body fluid or tissue that provides information regarding presence or absence of a disease, prognosis, or likelihood to respond to a specific treatment
Active surveillance Monitoring prostate cancer rather than immediately treating it
Prostate cancer Various definitions: in general, clinical, pathologic, or biomarker features of prostate cancer suggesting a possibility of becoming clinically relevant (symptoms or metastases)
Low-risk prostate cancer Gleason score ≤6 (Grade group 1), PSA <10 ng/ml, and non-palpable or only palpable in less than half of one lobe of the prostate (clinical stage T1c or T2a)
Intermediate-risk prostate cancer PSA 10-20 ng/ml, a clinical stage of T2b-T2c, or a Gleason score 7 (Grade group 2-3) grade without meeting any criteria for high-risk
High-risk prostate cancer Clinical stage T3a, Gleason score ≥8 (Grade group ≥4), or PSA ≥20 ng/ml
Very high-risk prostate cancer Clinical stage T3b-T4, any primary Gleason pattern 5 (Grade group 5) or >4 cores of Gleason score 8-10 (Grade group ≥4)
Assay validity Comprehensive experiments that evaluate and document the quan-titative performance of an assay, including sensitivity, specificity, accuracy, precision, reproducibility, detection limit, range and limits of quantitation.
Analytic validity How well a test predicts the presence or absence of a particular disease, condition, or state
Clinical validity How well the test result is related to the presence, absence, or risk of a specific disease
Clinical utility The ability of a screening or diagnostic test to prevent or ameliorate adverse health outcomes such as mortality, morbidity, or disability
Tumor heterogeneity Variability amongst cancer cells including cellular morphology, genomic alterations, gene expression, metabolism, proliferation, and metastatic potential
Predictive Biomarker Provides information regarding response to a specific treatment
Diagnostic Biomarker Provides information regarding the likelihood of disease presence or absence
Prognostic Biomarker Provides information about the patient’s overall cancer outcome (e.g., disease recurrence, progression, death) independent of treatment received.

Diagnosis

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