SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer

Groß, Michael; Sedrakyan, Art; Bianco, Fernando J.; Carroll, Peter R.; Daskivich, Timothy J.; Eggener, Scott E.; Ehdaie, Behfar; Fisher, Benjamin R.; Gorin, Michael A.; Hunt, Bradley; Jiang, Hongying; Klein, Eric A.; Marinac‐Dabic, Danica; Montgomery, Jeffrey S.; Polascik, Thomas J.; Priester, Alan; Rastinehad, Ardeshir R.; Viviano, Charles J.; Wysock, James S.; Hu, Jim C.

doi:10.1097/ju.0000000000000357

Cited by 9 publications

(5 citation statements)

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“…Four patients with biopsy-proven MRI-visible GG1-2 PCa were treated with focal Cryoablation. The remaining patients with unilateral non-MRI-visible PCa underwent prostate hemiablation according to the SPARED guidelines [17]. In total, 76 cores were taken and analyzed using FCM (Figure 2).…”

Section: Resultsmentioning

confidence: 99%

Intraoperative Digital Analysis of Ablation Margins (DAAM) by Fluorescent Confocal Microscopy to Improve Partial Prostate Gland Cryoablation Outcomes

Selvaggio

Falagario

Bruno

et al. 2021

Cancers

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Partial gland cryoablation (PGC) aims at destroying prostate cancer (PCa) foci while sparing the unaffected prostate tissue and the functionally relevant structures around the prostate. Magnetic Resonance Imaging (MRI) has boosted PGC, but available evidence suggests that ablation margins may be positive due to MRI-invisible lesions. This study aimed at determining the potential role of intraoperative digital analysis of ablation margins (DAAM) by fluoresce confocal microscopy (FCM) of biopsy cores taken during prostate PGC. Ten patients with low to intermediate risk PCa scheduled for PGC were enrolled. After cryo-needles placement, 76 biopsy cores were taken from the ablation margins and stained by the urologist for FCM analysis. Digital images were sent for “real-time” pathology review. DAAM, always completed within the frame of PGC treatment (median time 25 min), pointed out PCa in 1/10 cores taken from 1 patient, thus prompting placement of another cryo-needle to treat this area. Standard HE evaluation confirmed 75 cores to be cancer-free while displayed a GG 4 PCa in 7% of the core positive at FCM. Our data point out that IDAAM is feasible and reliable, thus representing a potentially useful tool to reduce the risk of missing areas of PCa during PGC.

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Section: Resultsmentioning

confidence: 99%

Intraoperative Digital Analysis of Ablation Margins (DAAM) by Fluorescent Confocal Microscopy to Improve Partial Prostate Gland Cryoablation Outcomes

Selvaggio

Falagario

Bruno

et al. 2021

Cancers

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“…Future studies must be prospective and protocol-driven in nature, with a clearly specified hypothesis and supported by robust power calculations and statistical analysis plans. Collaborative databases and online registries such as the Study of Prostate Ablation Related Energy Devices Coordinated Registry Network [49] and High Intensity Focused Ultrasound Evaluation and Assessment of Treatment Registry [50] provide a platform for sharing data and should be encouraged, although it has to be acknowledged that prospectively collected data from registries and databases are fundamentally retrospective in nature; such data are at best exploratory and should be used for hypothesis-generating rather than hypothesis-testing purposes. Consequently, careful attention must be paid to the study design.…”

Section: Implications For Clinical Practice and Further Researchmentioning

confidence: 99%

A Systematic Review of Focal Ablative Therapy for Clinically Localised Prostate Cancer in Comparison with Standard Management Options: Limitations of the Available Evidence and Recommendations for Clinical Practice and Further Research

Bates

Ayers

Κωστακόπουλος

et al. 2021

European Urology Oncology

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“…In some device areas, quality registries capturing more than 95% of procedures performed in USA provide a basis for such CRN lexicon 7 8. In other areas where no such infrastructure yet exists, the precompetitive, collaborative development of a minimum core data structure has been the successful focus of National Evaluation System for health Technology (NEST) Demonstration Programs (which provide proof of concept for scalable approaches to evidence generation across device types and across the total life cycle of a product) such as MDEpiNet’s RAPID (Registry Assessment of Peripheral Interventional Devices),9 and CRNs such as WHT-CRN (Women’s Health Technology)6 10 and SPARED-CRN (The Study of Prostate Ablation Related Energy Devices) 11 12…”

Section: Introductionmentioning

confidence: 99%

Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)

Long

Tcheng

Marinac‐Dabic

et al. 2022

BMJ Surg Interv Health Technologies

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Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a ‘coordinated registry network’ capability. On July 29, 2016, a workshop entitled, ‘GI Coordinated Registry Network: A Case for Obesity Devices’ was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public–private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing.

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SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer

Cited by 9 publications

References 0 publications

Intraoperative Digital Analysis of Ablation Margins (DAAM) by Fluorescent Confocal Microscopy to Improve Partial Prostate Gland Cryoablation Outcomes

Intraoperative Digital Analysis of Ablation Margins (DAAM) by Fluorescent Confocal Microscopy to Improve Partial Prostate Gland Cryoablation Outcomes

A Systematic Review of Focal Ablative Therapy for Clinically Localised Prostate Cancer in Comparison with Standard Management Options: Limitations of the Available Evidence and Recommendations for Clinical Practice and Further Research

Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)

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