Neal D. Shore, Naveen Kella, Brian Moran, Judd Boczko, Fernando J. Bianco, E. David Crawford, Thaylon Davis, Kirstin M. Roundy, Kristen Rushton, Charles Grier, Rajesh Kaldate, Michael K. Brawer, Mark L. Gonzalgo

The CCP test is a validated molecular assay that assesses prostate cancer-specific disease progression and mortality risk when combined with clinicopathologic parameters. The results from PROCEDE-1000, a large, prospective registry designed to evaluate the impact of the CCP test regarding shared treatment decision making for newly diagnosed prostate cancer patients, are presented here. Untreated patients with newly diagnosed prostate adenocarcinoma were enrolled and the CCP test was performed on the initial prostate biopsy tissue. A set of four sequential surveys tracked changes relative to initial therapy recommendations (pre-CCP) based on clinopathologic parameters following: physician review of the CCP test result, physician/patient review of the CCP test results, and a minimum of three-months of clinical follow-up (actual treatment). 1206/1596 patients enrolled in this registry were eligible for analysis. There was a significant reduction in the treatment burden recorded at each successive evaluation (P<0.0001), with mean number of treatments per patient decreasing from 1.72 pre-CCP test to 1.16 in actual follow-up. The CCP test caused a change in actual treatment in 47.8% of patients. Of these changes, 72.1% were reductions and 26.9% were increases in treatment. For each clinical risk category, there was a significant change in treatment modality (intervention vs. non-intervention) pre-CCP to post-CCP testing (P=0.0002). The CCP test has a significant impact in assisting physicians and patients reach personalized treatment decisions.