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CCP score stratifies risk for prostate cancer patients at biopsy: initial commercial results
E. David Crawford, MD1, Neal Shore, MD2, Peter T. Scardino, MD, FACS3, John W. Davis, MD, FACS4, Jonathan D. Tward, MD, PhD5, Lowndes Harrison6, Kelsey Moyes, MStat7, Lisa Fitzgerald8, Steven Stone, PhD8, Michael K. Brawer, MD7, Tony Luongo, MD9.
1University of Colorado Health Science Center, Aurora, CO, 2Carolina Urologic Research Center, Myrtle Beach, SC, 3Memorial Sloan-Kettering Cancer Center, New York, NY, 4The University of Texas MD Anderson Cancer Center, Houston, TX, 5University of Utah Huntsman Cancer Institute, Salt Lake City, UT, 6Gadsden Regional Cancer Center, Gladsden, AL, 7Myriad Genetic Laboratories, Inc., Salt Lake City, UT, 8Myriad Genetics, Inc., Salt Lake City, UT, 9Tufts Medical Center, Boston, MA.

BACKGROUND: New prognostic markers for prostate cancer play an important role in addressing the controversies of over diagnosis and treatment. The cell cycle progression score (CCP) is an RNA−based marker which improved the prediction of prostate cancer aggressiveness in nine separate cohorts. Each one−unit increase in CCP corresponds with approximately a doubling of the risk of the studied event (recurrence or death from prostate cancer). In this analysis, we characterized the CCP distribution from the initial commercial testing.
METHODS: A laboratory database was evaluated for patients whose biopsy was tested with the CCP score and whose clinicopathologic data was collected by the ordering physician. Formalin fixed, prostate biopsy tissue from 2734 patients diagnosed with adenocarcinoma ordered by 606 physicians were analyzed. The CCP score was calculated by measuring the RNA expression of 31 cell cycle progression genes normalized to 15 housekeeping genes.
RESULTS: Of the 2734 samples that contained sufficient carcinoma (>0.5mm linear extent), 2696 (98.6%) provided quality RNA for analysis. This retrospective analysis showed a normal distribution for the CCP ranging from −2.9 to 3.1. Correlation with Gleason score was r=0.35. A relative classification of cancer aggressiveness based on CCP of ~1200 patients from multiple cohorts was developed to interpret how the patient’s CCP score compared to that of patients within the same AUA risk category. The thresholds between each of the five intervals are one unit of CCP score apart, with the ‘consistent’ interval centered at the median CCP score. The table demonstrates how CCP modifies AUA risk. Based on the CCP score, 29.6% of men had a less aggressive cancer compared to the clinicopathologic prediction and were assigned to a lower risk group while 25.7% of patients had a more aggressive cancer.
CONCLUSIONS: The CCP test is a novel assay that can improve risk stratification for men with prostate adenocarcinoma independent of the Gleason score and PSA level. Over 50% of men initially tested in the commercial assay were assigned to a different risk category than predicted by their clinicopathologic features alone.
Cancer Aggressiveness Based on CCP Scores
AUA Risk ClassificationConsiderably Less AggressiveLess AggressiveConsistentMore AgressiveConsiderably More AggressiveTotals
Low18 (1.6%)311 (27.8%)520 (46.4%)247 (22.1%)24 (2.1%)1120
Intermediate29 (2.4%)324 (26.8%)548 (45.4%)261 (21.6%)45 (3.7%)1207
High17 (4.6%)99 (26.8%)137 (37.1%)85 (23.0%)31 (8.4%)369
Totals64 (2.4%)734 (27.2%)1205 (44.7%)593 (22.0%)100 (3.7%)2696


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