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. 2024 Mar 19;14(2):508-520.
doi: 10.3390/clinpract14020039.

Tissue-Based Genomic Testing in Prostate Cancer: 10-Year Analysis of National Trends on the Use of Prolaris, Decipher, ProMark, and Oncotype DX

Eugenio Bologna  1   2 , Francesco Ditonno  1   3 , Leslie Claire Licari  1   2 , Antonio Franco  1   4 , Celeste Manfredi  1   5 , Spencer Mossack  1 , Savio Domenico Pandolfo  6 , Cosimo De Nunzio  4 , Giuseppe Simone  7 , Costantino Leonardo  7 , Giorgio Franco  2
Affiliations

Tissue-Based Genomic Testing in Prostate Cancer: 10-Year Analysis of National Trends on the Use of Prolaris, Decipher, ProMark, and Oncotype DX

Eugenio Bologna et al. Clin Pract. .

Abstract

Background: Prostate cancer (PCa) management is moving towards patient-tailored strategies. Advances in molecular and genetic profiling of tumor tissues, integrated with clinical risk assessments, provide deeper insights into disease aggressiveness. This study aims to offer a comprehensive overview of the pivotal genomic tests supporting PCa treatment decisions, analyzing-through real-world data-trends in their use and the growth of supporting literature evidence.

Methods: A retrospective analysis was conducted using the extensive PearlDiver™ Mariner database, which contains de-identified patient records, in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes were employed to identify patients diagnosed with PCa during the study period-2011 to 2021. We determined the utilization of primary tissue-based genetic tests (Oncocyte DX®, Prolaris®, Decipher®, and ProMark®) across all patients diagnosed with PCa. Subsequently, within the overall PCa cohort, patients who underwent radical prostatectomy (RP) and received genetic testing postoperatively were identified. The yearly distribution of these tests and the corresponding trends were illustrated with graphs.

Results: During the study period, 1,561,203 patients with a PCa diagnosis were recorded. Of these, 20,748 underwent tissue-based genetic testing following diagnosis, representing 1.3% of the total cohort. An increasing trend was observed in the use of all genetic tests. Linear regression analysis showed a statistically significant increase over time in the use of individual tests (all p-values < 0.05). Among the patients who underwent RP, 3076 received genetic analysis following surgery, representing 1.27% of this group.

Conclusions: Our analysis indicates a growing trend in the utilization of tissue-based genomic testing for PCa. Nevertheless, they are utilized in less than 2% of PCa patients, whether at initial diagnosis or after surgical treatment. Although it is anticipated that their use may increase as more scientific evidence becomes available, their role requires further elucidation.

Keywords: AS; PCa; aRT; active surveillance; adjuvant therapies; genetic tests.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Bar Plot Depicting Utilization Trends of Four Tissue-Based Genomic Tests Over Study Period in Overall PCa Patients.
Figure 2
Figure 2
Trends in the Use of Decipher® and Promark® after Radical Prostatectomy Over the Study Period (2011–2021).
See this image and copyright information in PMC

References

    1. Hamdy F.C., Donovan J.L., Lane J.A., Metcalfe C., Davis M., Turner E.L., Martin R.M., Young G.J., Walsh E.I., Bryant R.J., et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N. Engl. J. Med. 2023;388:1547–1558. doi: 10.1056/NEJMoa2214122. - DOI - PubMed
    1. Tohi Y., Kato T., Sugimoto M. Aggressive Prostate Cancer in Patients Treated with Active Surveillance. Cancers. 2023;15:4270. doi: 10.3390/cancers15174270. - DOI - PMC - PubMed
    1. Schaeffer E.M., Srinivas S., Adra N., An Y., Barocas D., Bitting R., Bryce A., Chapin B., Cheng H.H., D’amico A.V., et al. Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology. J. Natl. Compr. Cancer Netw. 2023;21:1067–1096. doi: 10.6004/jnccn.2023.0050. - DOI - PubMed
    1. Mottet N., van den Bergh R.C.N., Briers E., van den Broeck T., Cumberbatch M.G., De Santis M., Fanti S., Fossati N., Gandaglia G., Gillessen S., et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer—2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur. Urol. 2020;79:243–262. doi: 10.1016/j.eururo.2020.09.042. - DOI - PubMed
    1. Cooperberg M.R., Meeks W., Fang R., Gaylis F.D., Catalona W.J., Makarov D.V. Time Trends and Variation in the Use of Active Surveillance for Management of Low-risk Prostate Cancer in the US. JAMA Netw. Open. 2023;6:e231439. doi: 10.1001/jamanetworkopen.2023.1439. - DOI - PMC - PubMed