Johnson & Johnson has funded the development and publication of this article, including a consultancy fee for Lynda Corrigan and Stephen Finn. The views expressed in the article are those of the authors and publisher, and do not necessarily reflect the views of Johnson & Johnson. CP-545172 | October 2025.
Prostate cancer is the most commonly diagnosed cancer in men in Europe, and precision oncology in this field is evolving rapidly (1). Yet more can and must be done to fully realize its potential, particularly in the uptake and implementation of biomarker testing across healthcare systems. Progress to date has relied on large-scale multidisciplinary collaboration and active patient engagement, both of which will remain critical as the field continues to advance.
For decades, standard management of advanced prostate cancer primarily relied on androgen deprivation therapy (2). The landscape is steadily shifting as insights into the clinical relevance of homologous recombination repair (HRR) and DNA damage repair (DRR) alterations create new opportunities and highlight the growing importance of understanding the genetic drivers of every individual’s disease. For example, we now know that up to one in four patients with metastatic prostate cancer harbor HRR alterations, including BRCA1/2 mutations, among others (3–5). Establishing mutational status at diagnosis enables personalized care, informs prognosis, and guides management for patients most likely to benefit from targeted therapies.
From zero to 100…
This new era of precision medicine brings both promise and challenges that must be addressed to ensure patients can benefit from the treatment most likely to derive an improved outcome, at the optimal point in their disease trajectory. While progress in precision medicine is advancing, it is comparatively less well established in prostate cancer than other biomarker-driven solid tumors such as lung or breast cancer. Clinical infrastructure, laboratory capacity, and physician education are evolving to keep pace with the growing demand for biomarker testing.
Fragmented access across Europe calls for a strong local process
Clinical guidelines increasingly support the integration of molecular diagnostic testing to guide treatment decisions (6). However, Europe’s diverse healthcare infrastructures, funding mechanisms, and regulatory environments create a fragmented system in which the uptake and availability of biomarker testing vary considerably by country and institution (7). More important than striving for complete standardization in testing practices across Europe, however, is the need for each local institution to establish a high standard of testing and a clearly defined testing pathway integrated into routine clinical practice.
Similarly, practical improvements in workflow can also make a significant impact. Many centers rely on manual paperwork and physical sample transfers, which may create bottlenecks and result in delays along the testing pathway. Digital test-ordering, streamlined test requesting, and standardized reporting systems can improve turnaround times from sample acquisition through to reporting of results, while also reducing administrative burden.
Rethinking timing and workflow
Perhaps the greatest technical barrier is tissue quality. Research shows failure rates of approximately 30 to 40 percent on tumor tissue testing in patients with metastatic castration resistant prostate cancer (8). This is mainly due to limited tissue availability after diagnostic histology, insufficient tumor content, and DNA degradation or poor DNA yield (9).
Improving outcomes requires rethinking not only how but also when testing is performed. Testing at the onset of metastatic disease rather than castrate resistance may provide higher-quality samples and reduce reliance on suboptimal archival tissue for those with de novo disease. This is more challenging for patients with recurrent disease, although earlier molecular testing in high-risk localized prostate cancer patients, such as those with Gleason 8 or higher-grade tumors, may become an area of interest.
A complete approach to biomarker testing also requires integration of both somatic and germline analyses, particularly for BRCA1/2 mutations where patients tend to have particularly poor outcomes (10). Effective precision medicine necessitates coordination between tumor molecular pathology and cancer genetics to ensure comprehensive patient management.
A further opportunity lies in how cases are discussed across multidisciplinary forums. In many cases, patients are presented at multidisciplinary team (MDT) meetings after test results have returned, but earlier discussion could optimize the pathway. For example, if pathologists and oncologists evaluate upfront whether available tissue is adequate for molecular analysis, they can anticipate challenges and plan alternative strategies before delays occur.
Similarly, molecular tumor boards (MTBs) play an increasingly important role in ensuring precision medicine delivers value in practice. Beyond interpreting complex genomic findings, MTBs can also systematically review failed tests, identify reasons for failure and recommend process improvements. Embedding a culture of continuous audit and feedback within these forums helps to optimize testing pathways, minimize repeat failures, and ultimately shorten the time to clinically actionable results.
These meetings, and proactive, open communication among all stakeholders in the care pathway are critical to institutional process enhancements that will benefit patients.
Pathologists at the center of precision oncology
In this often complex and evolving landscape, the role of the pathologist is more critical than ever. Every pathologist, regardless of subspecialty, must increasingly act as a molecular pathologist to some extent. This means understanding the requirements and limitations of molecular testing, the adequacy of tissue samples, and the impact of their initial diagnostic decisions on downstream analyses.
Greater education and training around molecular techniques, tissue selection, and sample preservation are essential. A biopsy that is adequate for histological diagnosis may not always meet the needs of genomic testing. By embedding molecular considerations into routine diagnostic workflows, pathologists can help ensure that patients are not disadvantaged later in the pathway by insufficient or degraded material.
Emerging approaches and future directions
Liquid biopsy, specifically analysis of circulating tumor DNA (ctDNA), is poised to play an increasingly important role in the prostate cancer clinical pathway, offering a minimally invasive method to capture tumor genetic information (11). Concurrently, genomic classifier scores, such as the Decipher Prostate Test, and artificial intelligence platforms that integrate histopathology with clinical factors are beginning to refine prognostic assessment and further guide personalized treatment strategies (12,13). While promising, these approaches have their own limitations and require validation and considered integration into clinical workflows to ensure reliability and utility.
If we aim for precision medicine to truly benefit people living with prostate cancer, it is our responsibility as clinicians to better understand the underlying tumor biology and effectively integrate biomarker testing seamlessly into routine care. We must call for continued learning and education, clearly defined institutional processes and pathways, a commitment to timely turnaround and multidisciplinary alignment. We should also support informed patient decision-making, by providing information around targeted treatment options and associated biomarker testing.
As medical practitioners, we will always face hurdles or barriers, but we must continue to proactively advocate for and drive the change necessary to ensure that every patient has access to the right treatment. Only then can patients across diverse healthcare settings fully benefit from this new era of precision oncology innovation.
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References
- Intenational Agency for Research on Cancer, “ Global Cancer Observatory: Europe” (2024). Available at: http://bit.ly/47incCt.
- G Gravis, The Lancet Oncology, 24, 5 (2023). PMID: 37142365.
- AM Lee, et al., Clin Genitourin Cancer, 20, 6 (2022). PMID: 35871039.
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- VD de Jager et al., The Lancet Reg Health Eur, 38 (2024). PMID 38476742.
- European Cancer Patient Coalition, “Unlocking the potential of precision medicine in Europe – improving cancer care through broader access to quality biomarker testing.” Available at: http://bit.ly/4q8zF2Y.
- M Hussain et al., Clin Cancer Res, 28, 8 (2022). PMID: 35091440.
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