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.

Comparison of intensity-modulated radiosurgery with gamma knife radiosurgery for challenging skull base lesions.

PURPOSE: To quantitatively compare intensity-modulated radiosurgery (IMRS) using 3-mm mini-multileaf collimation with gamma knife radiosurgery (GKRS) plans for irregularly shaped skull base lesions in direct proximity to organs at risk (OAR). METHODS AND MATERIALS: Ten challenging skull base lesions originally treated with GKRS were selected for comparison with IMRS using inverse treatment planning and 3-mm mini-multileaf collimation operating in step-and-shoot delivery mode. The lesions ranged in volume from 1.6 to 32.2 cm(3) and were treated with 9-20 GK isocenters (mean 13.2). The IMRS plans were designed with the intent to, at minimum, match the GKRS plans with regard to OAR sparing and target coverage. For each case, IMRS plans were generated using 9 coplanar, 11 equally spaced noncoplanar, and 11 OAR-avoidant noncoplanar beams; the best of these approaches with respect to target conformality, sparing of OAR, and maintaining coverage was selected for comparison with the original GKRS plan. RESULTS: Assuming no patient motion or setup error, IMRS provided comparable target coverage and sparing of OAR and an improved conformity index at the prescription isodose contour but sometimes less conformity at lower isodose contours compared with the actual GKRS plan. All IMRS plans produced less target dose heterogeneity and shorter estimated treatment times compared with the GKRS plans. CONCLUSION: Compared with GKRS for complex skull base lesions, IMRS plans using a 3-mm mini-multileaf collimator achieved comparable or sometimes improved target coverage, conformity, and critical structure sparing with shorter estimated treatment times.

The effect of beam energy and number of fields on photon-based IMRT for deep-seated targets.

PURPOSE: To examine the influence of energy and number of beams on nontarget dose when using intensity-modulated radiation therapy (IMRT) to treat deep-seated targets. METHODS AND MATERIALS: Ten patients with prostate cancer (36-226 cc) treated locally to 75.6 Gy were studied. IMRT plans were created for 6-, 10-, and 18-MV photons using 4, 6, 9, and 11 coplanar nonopposed fields. Plans, normalized to cover 95% of the target volume, were analyzed using: (a) conformity index (CI) at 105%, 100%, 95%, 90%, 80%, 70%, 50% of prescribed dose; (b) prescription isodose line (PI); (c) minimum dose to target (Tar(min)); (d) maximum dose to tissue (Tis(max)); (e) dose to rectum/bladder/penis bulb; (f) integral nontarget dose (ID). Because CI evaluates dose independent of location, tissue also was divided into "near region" (NR: 1-cm-thick shell surrounding target) and "far region" (FR: tissue minus NR) volumes that were evaluated at the same levels as CI. RESULTS: The target and sensitive structure metrics were the same for all plans. However, although there was little difference in NR volume exposed to dose, regardless of energy or number of fields, there was a significant increase in FR volume exposed to dose, at all levels, for low energy/few field plans compared to high energy/many fields (e.g., > 50 cc >or= 65 Gy). This effect disappeared with >or= 9 fields regardless of energy. CONCLUSION: With IMRT, the use of 6 MV photons with less than 9 fields may result in an increase in dose in regions distant from the target volume (e.g., near the skin surface), even though the CI and sensitive structure metrics may indicate good conformance of high dose to the target volume itself. The clinical significance of this increased dose distant from the target, in terms of complications, remains to be determined.