Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Limitations of the National Comprehensive Cancer Network® (NCCN®) Guidelines for Prediction of Limited Life Expectancy in Men with Prostate Cancer.

PURPOSE: National Comprehensive Cancer Network prostate cancer guidelines for the prediction of life expectancy recommend subtracting 50% of life table predicted longevity for those in the lowest quartile of health. However, it is unclear how to identify these men and if their survival is uniform. MATERIALS AND METHODS: We sampled records of 1,482 men diagnosed with prostate cancer from 1998 to 2004 at 2 VA hospitals. We identified men in the lowest quartile of health by age using Charlson scores, calculated their NCCN predicted life expectancy, and compared this with observed median survival in aggregate and across comorbidity subgroups. RESULTS: Men with Charlson scores of 2+ (age less than 75 years) and 3+ (age 75 years or older) comprised the lowest quartile of health. Among those younger than 65, 65 to 69, 70 to 74, 75 to 79 and 80 years or older, observed survival vs NCCN predicted life expectancy in years was similar at 10.4 vs 11.1, 10.0 vs 7.8, 6.2 vs 6.4, 4.4 vs 4.9 and 3.7 vs 3.3, respectively. Yet within the lowest quartile there was significant heterogeneity in survival among men with differing Charlson scores. For example, men age 65 to 69 years with Charlson scores 2, 3 and 4+ had an observed median survival greater than 13.3, 9.4 and 4.3 years, respectively. NCCN guidelines misclassified 10-year life expectancy in 24% and 56% of men age less than 65 and 65 to 69 years, and 5-year life expectancy in 18% of men age 70 to 74 years. CONCLUSIONS: While NCCN predictions matched observed survival on average for the lowest quartile of health, there was substantial heterogeneity in survival by Charlson scores. More granular assessments of life expectancy should be used for those at highest risk for mortality.