Systematic Review of Genomic-Based Risk Stratification in Localised Prostate Cancer Treatment Optimisation: Clinical Impact and Health Economic Evidence.

[BACKGROUND] Several genomic risk stratification tests are available to predict the risk of metastasis and mortality for prostate cancer patients at the time of diagnosis. However, the evidence supporting the clinical utility of genomic risk stratification tools is fragmented, posing challenges in assessing their real-world clinical impact and cost-effectiveness.

[OBJECTIVE] To review and summarise the clinical impact and health economic evidence of the four types of genomic risk stratification tests and to validate their clinical impact and health economic evaluation outcomes.

[METHOD] A systematic search was conducted in the Scopus, EMB Reviews and Google Scholar databases. Eligible publications were selected based on the eligible patient cohort, genomic test, initial NCCN risk categories, the clinical impact of the genomic test and health evaluation outcomes.

[CONCLUSION] 26 clinical impact evidence studies and four health economic evaluation studies were included. Most clinical studies indicated that genomic tests reclassified patients' risk predictions into both lower- and higher-risk groups. The reclassification outcomes influenced patients' treatment decisions between active surveillance and radical treatment. The prognostic value of the genomic tests was validated in terms of biopsy upgrade, metastasis and death. The limited number of health economic studies reported that the Oncotype DX Prostate Score and ProMark were cost-effective, while the Prolaris was cost-saving in the US but not in Canada. The evaluation of the Decipher Genomic Classifier at the time of diagnosis was not available. More long-term clinical evidence is needed, as are updated health economic evaluations, to determine the cost-effectiveness of integrating genomic risk stratification into prostate cancer treatment decision-making in clinical practice.