Table 1.

Biomarker selection criteria and considerations

Interest of the biomarker based on extensive preliminary data

Relevance to CPCBN objectives and clinical impact for prostate cancer

Cohort size used to determine biomarker status

Assay performed on paraffin-embedded tissue or TMA

Staining quality and requirements that include the following: • Reliable staining against controls and background levels using an automated stainer • Antibody specificity validated by western blot or IHC/immunofluorescence with appropriate controls • Preferences towards monoclonal antibody use • Preferences towards digital image analysis

Specific role in prostate cancer prognosis and supporting statistical data (BCR, development of metastasis, p value)

Sufficient resources for biomarker analysis (proposed laboratory, supportive infrastructure, funding, and partners)