SupplementaryTable 1: Biomarker selection criteria

Biomarkers were selected for this systematic review if
Original data were identified and/or
Clinical studies with methodological appraisal were conducted and/or
CE/FDA certification wasattributed and/or
Measurements were performed in CLIA-certified (or candidate for certification) laboratories and/or
Impact of these biomarkers in clinical practice was heterogeneous and represented a risk of inequality in patients’ healthcare.
Biomarkers were excluded from this systematic review if
They had not reached the clinical phase of assessment and/or
They were not commercialized in a unique test format.
They had been evaluated in well-structured systematic reviewsthat failed to show any prognostic value.

Finally, two blood tests (Prostate Health Index,PHI, from Beckman Coulter; and 4Kscore® from OPKO), ne urinary test (Mi Prostate Score Urine test, MiPS, from Mlabs) and three molecular signatures (Genomic Prostate Score, GPS®, from Genomic Health; Cell Cycle Progression score, CCP, Prolaris® from Myriad Genetics; and Genomic Score, GC, Decipher® from GenomeDX) were selected for the studyon the basis of their potential prognostic value in prostate cancer.

The PCA3 score (Progensa, Hologic)was evaluated in several international studies or for recommendations established using an available and validated methodology:

1)“Diagnosing prostate cancer: PROGENSA; PCA3 assay and Prostate Health Index, Diagnostics guidance; Published: 2 June 2015”

«The Committee concluded that there was insufficient evidence to determine the clinical effectiveness of using the PCA3 assay … for the detection of more aggressive cancers.»

2)Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016/j.eururo.2010.10.039.

“There are conflicting data on whether PCA3 levels are related to tumour aggressiveness”.

3)Heidenreich A1, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology.Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and local treatment with curative intent-update 2013.

«…. there are conflicting data on whether the PCA3 score independently predicts the Gleason score, and its use as a monitoring tool in active surveillance has not been confirmed ...».

Based on these already published studies, the PCA3score alone was not evaluated in this review.