Cell cycle progression score and treatment decisions in prostate cancer: results from an ongoing registry

Abstract

Objective:

The cell cycle progression (CCP) test (Prolaris) is a novel prognostic assay that provides accurate risk of prostate cancer-specific disease progression and disease specific mortality when combined with standard clinicopathologic parameters. This prospective study evaluated the impact of the CCP report on physician treatment recommendations for prostate cancer.

Methods:

Physicians ordering the CCP test in clinical practice completed surveys regarding treatment recommendations before and after they received and discussed the test results with patients. Clinicians also rated the influence of the test result on treatment decisions. Treatment selections were confirmed via third-party audit of patient charts following final survey responses.

Results:

Overall, 65% of cases showed a change between intended treatment pre- and post-CCP test reporting. Pre-CCP testing, 164 of 305 cases received a recommendation for interventional treatment. Post-CCP test, interventional therapy was recommended for 103 of these cases, a reduction of 37.2%. Conversely, 141 of 305 cases were recommended pre-CCP testing for non-interventional treatment; 108 of these remained with non-interventional treatment while 33 shifted to interventional options, a 23.4% increase. There was a 49.5% reduction in surgical interventions and a 29.6% reduction in radiation treatment. A third-party audit identified 80.2% concordance between the post-CCP testing treatment recommendation and actual treatment. Re-assignment to intervention or non-intervention generally correlated with the result of the CCP report. Study limitations included physician selection of patients for testing, no evaluation of patient input in therapeutic choice, and other potential treatment decision factors not queried by the survey.

Conclusion:

Based on responses of ordering physicians, the CCP report adds meaningful new information to risk assessment for localized prostate cancer patients. Test results led to changes in treatment with reductions and increases in interventional treatment that were directionally aligned with prostate cancer risk specified by the test.

Keywords::

• Biomarker
• CCP score
• Clinical utility
• Physician surveys
• Prostate cancer

Transparency

Declaration of funding

This study was funded by Myriad Genetics Inc.

Declaration of financial/other relationships

A.H., R.R.K., and M.K.B. have disclosed that they are employed by Myriad Genetic Laboratories Inc., and receive salary and stock options. M.C.S. has disclosed that he has received research funding from Myriad Genetics Inc. E.D.C. has disclosed that he has received honoraria from and served on advisory boards for Myriad Genetics Inc. A.J.K. and J.E.F have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have received an honorarium for their review work from CMRO, but have no other relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Kirstin Roundy of Myriad Genetics Inc. for her assistance with editing and submitting this manuscript.

Notes

*Prolaris is a registered trade name of Myriad Genetic Laboratories Inc., Salt Lake City, UT, USA

*Prolaris is a registered trade name of Myriad Genetic Laboratories Inc., Salt Lake City, UT, USA