Prolaris CCR score demonstrates prognostic value in localized prostate cancer

A large individual patient data (IPD) meta-analysis published in Clinical Genitourinary Cancer suggests that the Prolaris Biopsy Test's combined clinical risk (CCR) score provides prognostic information beyond established clinicopathologic risk stratification tools in men with localized prostate cancer.¹

Investigators reported that the molecular-clinical score remained independently associated with distant metastasis (DM) and prostate cancer-specific mortality (PCSM) across multiple National Comprehensive Cancer Network (NCCN) risk groups and initial management strategies, supporting its potential role in refining risk assessment during treatment decision-making.

The Prolaris Biopsy Test is a tissue-based RNA assay that measures expression of cell cycle-related genes from prostate biopsy specimens and integrates these findings with clinical variables to generate a CCR score. The assay is intended to provide individualized prognostic information at diagnosis to supplement traditional clinical risk assessment.

“Our study shows that this tissue-based RNA test built on an array of cell cycle genes can provide prognostic information beyond clinical features alone, like [Cancer of the Prostate Risk Assessment] CAPRA or NCCN, in localized prostate cancer,” said study author Steven M. Monda, MD, urologist and clinical instructor at the University of Michigan Health, in a news release on the results.² “Further, CCR is prognostic for prostate cancer-specific mortality, even in low-risk patients. That’s useful in active surveillance conversations, where you want additional information about a patient’s individual cancer risk to inform counseling and surveillance intensity.”

About the study

The systematic review and two-stage IPD meta-analysis included 14 eligible studies comprising 8,478 patients, of whom 7,924 had analyzable IPD collected from 74 sites between 1994 and 2020. The cohort included patients spanning the NCCN low- (20%), favorable intermediate- (33.9%), unfavorable intermediate- (32.5%), and high-risk (13.6%) categories. Initial management strategies reflected contemporary practice patterns, including active surveillance or other noninterventional management (43.0%), prostatectomy (23.6%), radiation therapy alone (16.4%), and multimodal therapy with radiation plus androgen deprivation therapy (14.6%).

The primary end point was a composite of DM and PCSM. Using Cox proportional hazards models within individual cohorts followed by random-effects meta-analysis, investigators found that the CCR score remained significantly associated with the composite end point after adjustment for initial management (HR, 2.28; 95% CI, 1.98 to 2.62; P = 9.1 × 10^-9). Similar associations were observed for DM (P = 1.9 × 10⁻⁶) and PCSM (P = 9.7 × 10⁻⁴) when evaluated separately.

The CCR score remained independently prognostic after accounting for commonly used clinical risk assessment tools, including Gleason grade (P = 1.2 × 10−7), the CAPRA score (P = 1.9 × 10−6), and NCCN risk group (P = 2.1 × 10−8). Investigators additionally reported that the molecular cell cycle progression component of the CCR score (which includes 31 mRNA cell-cycle biomarkers) contributed prognostic information to CAPRA across all end points (all P < .005). According to the authors, this finding “further [demonstrates] CCR is more prognostic that clinicopathologic features alone.”

Receiver operating characteristic analyses similarly favored the CCR score over conventional clinical models. According to the investigators, time-dependent area under the curve (AUC) values exceeded 80% for most evaluated time points (12 of 18) and generally outperformed CAPRA score, Gleason score, and NCCN risk classification (17 of 18 assessments).

The analysis also examined clinically relevant treatment thresholds generated by the Prolaris report. Prolaris thresholds were significantly prognostic for the DM-PCSM end point when comparing candidates for active surveillance vs candidates for definitive treatment (HR, 0.21; 95% CI, 0.08 to 0.56; P = .015) and candidates for multimodal therapy vs candidates for single-modality treatment (HR, 4.91; 95% CI, 3.73 to 6.46; P = 2.6 × 10−6).

Based on these data, the authors concluded, “This high-quality evidence demonstrates that Prolaris, when used as suggested in guidelines, is a powerful advanced prognostic tool that provides superior prognostic performance to standard tools to aid in clinical management of localized prostate cancer.”

REFERENCES
1. Morgan TM, Lenz LH, Henriquez I, et al. Robust meta-analysis of a clinical cell-cycle risk (CCR) score demonstrates broadly applicable metastasis and disease-specific mortality risk stratification in men with localized prostate cancer. Clin Genitourin Cancer. 2026:102586. doi:10.1016/j.clgc.2026.102586

2. New large-scale meta-analysis demonstrates strong prognostic performance of Myriad’s Prolaris® Biopsy Test in localized prostate cancer. News release. Myriad Genetics. July 2, 2026. Accessed July 7, 2026. https://investor.myriad.com/news-releases/news-release-detail/27451/