New data presented at the ASCO Genitourinary Cancers Symposium provide robust evidence supporting the clinical utility of Prolaris in patients with localized prostate cancer.

The findings are based on a large-scale individual participant data (IPD) meta-analysis including 7,926 patients from 14 studies (15 cohorts), representing one of the most comprehensive evaluations of a genomic test in this setting to date.

Strong and consistent prognostic performance

The Prolaris Combined Clinical Risk (CCR) score demonstrated significant prognostic value across multiple clinically relevant endpoints:

• Composite endpoint (DM-PCSM): HR 2.28 (95% CI 1.98-2.62, p=9.14×10⁻⁹)
• Distant metastasis (DM): HR 2.80 (95% CI 2.22-3.53, p=1.9×10⁻⁶)
• Prostate cancer-specific mortality (PCSM): HR 2.18 (95% CI 1.70-2.80, p=9.7×10⁻⁴)

Importantly, the CCR score remained highly significant after adjustment for initial treatment strategy, including non-interventional management, surgery, radiation therapy, and multimodal approaches.

Independent value beyond standard clinical risk factors

Additional analyses confirmed that Prolaris provides independent prognostic information beyond established clinical parameters, including:

• Gleason score: HR 2.29 (95% CI 1.97-2.67, p=1.2×10^-7)
• CAPRA score: HR 3.19 (95% CI 2.38-4.29, p=1.1×10^-6)
• NCCN risk classification: HR 2.23 (95% CI 1.95-2.56, p=2.1×10⁻⁵)

Robustness and consistency across cohorts

The results showed low heterogeneity (I² = 14%), indicating strong consistency across studies. Sensitivity analyses confirmed that findings were not driven by any single cohort, further supporting the robustness of the data.

Clinical relevance across treatment strategies

Prolaris demonstrated consistent prognostic performance across all management strategies, including:

• Active surveillance
• Single-modality treatment (surgery or radiation)
• Multimodal therapy

Notably, patients classified by Prolaris as suitable for active surveillance showed significantly lower risk of adverse outcomes compared to those recommended for definitive therapy, highlighting its value in guiding treatment decisions.

Advancing personalized prostate cancer care

“These results reinforce the clinical value of Prolaris in supporting more precise and individualized treatment decisions,” said Stephanie Ahrendt, Global Medical Science Liaison Manager Eurobio Scientific “By complementing conventional clinical parameters with genomic insights, Prolaris enables better risk stratification and more confident management of localized prostate cancer.”

See full poster here: 2026_ASGO-GU_Monda_MetaAnalysis

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