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Liquid biopsy in prostate cancer: A multidisciplinary expert consensus statement.

Francesco Pepe1, Davide Seminati2, Gustavo Baldassarre3

  • 1Department of Public Health, University of Naples Federico II, Naples, Italy.

Tumori
|September 29, 2025
PubMed
Summary

Liquid biopsy for BRCA1/2 gene testing offers a minimally invasive option for metastatic castration-resistant prostate cancer (mCRPC) when tissue is unavailable. This consensus provides recommendations to standardize testing and improve patient outcomes.

Keywords:
BRCA1/2 testingcfDNAliquid biopsymCRPCnext-generation sequencing

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Area of Science:

  • Oncology
  • Genetics
  • Molecular Diagnostics

Background:

  • Tissue biopsy limitations in metastatic castration-resistant prostate cancer (mCRPC) necessitate alternative methods for genetic testing.
  • BRCA1/2 gene mutations are crucial biomarkers for PARP inhibitor therapy in mCRPC.

Purpose of the Study:

  • To develop consensus recommendations for standardized BRCA1/2 testing using liquid biopsy in mCRPC.
  • To address technical challenges in pre-analytical, analytical, and post-analytical workflows for liquid biopsy testing.

Main Methods:

  • A multidisciplinary panel of 18 Italian experts convened to establish consensus recommendations.
  • Virtual and on-site meetings were conducted to identify and address technical gaps.
  • Statements were approved by at least 80% of panelists, reflecting current evidence and expert practice.

Main Results:

  • Liquid biopsy for BRCA1/2 testing is widely adopted or imminent in Italian centers, despite standardization challenges.
  • Key technical insights include the use of cfDNA-preserving tubes, optimal storage, high assay sensitivity (LoD <1.0%), and bioinformatic integration.
  • Next-generation sequencing covering coding and flanking regions was preferred, with a proposed harmonized synoptic report structure.

Conclusions:

  • Liquid biopsy integration enhances access to BRCA1/2 stratification for mCRPC patients, supporting PARP inhibitor therapy.
  • Standardized liquid biopsy testing improves diagnostic consistency and clinical decision-making.
  • This consensus aims to optimize the management of mCRPC through improved diagnostic accuracy and timely treatment initiation.