Background

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In light of the ever-expanding options to treat prostate cancer, the Study of Prostate Ablation Related Energy Devices (SPARED) CRN was initiated by the MDEpiNet Coordinating Center at Weill Cornell Medicine, in collaboration with a multi-disciplinary group of stakeholders. This effort will collect clinical information regarding patient and treatment characteristics as well as outcomes following prostate ablation. Armed with data from SPARED, clinicians will be better equipped to help inform men with prostate cancer regarding the pros and cons of focal therapy. In addition, industry will be better-informed regarding opportunities for technology improvement, and payers will be armed with effectiveness data for decisions regarding coverage of novel technologies.

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Prostate cancer is the most commonly diagnosed solid tumor in US men with estimated 174,650 new cases in 2019 and estimated deaths 31,620. Men diagnosed with prostate cancer have multiple options when choosing treatment, including radiation therapy, radical prostatectomy, active surveillance, and partial gland ablation (focal therapy). In contrast to traditional whole gland treatments such as radiation therapy and surgery, which have long-term data available to guide patient and clinician decision-making, focal therapy is a newer treatment with an absence of long-term data. The rapid adoption of novel but unproven technologies for prostate ablation has created the need to monitor the safety and effectiveness in the post-market arena. Following the recent approval of high-intensity focused ultrasound (HIFU) for ablation of prostate tissue, it is expected that more companies with novel technologies will apply for FDA clearance/approval.

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Objectives

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The overarching objective of SPARED CRN is to create a comprehensive clinical database to facilitate patient-centered research for existing and emerging focal therapy technologies. The acquisition of nationally representative treatment characteristics and clinical outcomes for prostate ablation technologies will serve to guide clinical decision and policy making in the absence of randomized clinical trials. The incorporation of the unique device identifier for medical devices in the SPARED registry will aid to identify and address device-related safety issues. This registry is a multi-institutional effort to prospectively obtain real-world clinical data on prostate-sparing ablative devices including HIFU, cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and future technologies.

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Partnership Structure

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The SPARED registry is an effort facilitated by the MDEpiNet Coordinating Center at Weill Cornell Medicine in collaboration with a multi-disciplinary group of stakeholders. Collaborators include Weill Cornell Medicine, Johns Hopkins University, Memorial Sloan Kettering, University of California (Los Angeles, San Diego, San Francisco, and Irvine), Columbia University, MD Anderson, Stanford University, University of Chicago, University of Michigan, University of Texas Medical Branch, three community sites within Healthtronics/cryo on-line database (COLD) registry, as well as other investigators, academics, vendors and industry partners.

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SPARED CRN committees include the Clinical Informatics and Partnership & Sustainability committees to schedule meetings, define group deliverables, and propose milestones and timelines. SPARED CRN also has a publications committee to review requests for de-identified or limited datasets from the SPARED registry.

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SPARED CRN leadership includes Charles Viviano (FDA), Jim Hu (Weill Cornell Medicine) Danica Marinac-Dabic (FDA), Art Sedrakyan (Weill Cornell Medicine), Benjamin Fisher (FDA), Michael Gorin (Johns Hopkins), and Fernando Bianco (Urological Research Network).

 

Existing agreements

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All participating CRNs have established a memorandum of understanding with the MDEpiNet Coordinating Center to join the CRN collaborative learning communities and are members of the MDEpiNet executive operations committee. SPARED is coordinated out of the James Buchanan Brady Urological Institute at Johns Hopkins University School of Medicine (Principal Investigator: Michael Gorin). Data collection for inclusion in the SPARED Registry was previously approved by the Johns Hopkins Institutional Review Board (IRB). All participating sites have obtained local IRB approval and patients have signed informed consent allowing for data collection and related analyses.

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Data Infrastructure

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Patient population

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SPARED CRN has an estimated 1,000 patients in its various institutional registries that are transitioning to single data platform and expanding data collection efforts.

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Data sources

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Medical records are reviewed for demographics, cancer stage and grade, details of treatment, oncologic follow-up (i.e. subsequent biopsies, PSA values, surveillance imaging, additional treatments, etc.), quality of life assessments, and the occurrence of complications.

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Current Projects and Plans

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SPARED CRN’s ongoing project includes active surveillance and comparative evaluation of new technologies in urological oncology using free-text electronic health record data. The project aims to develop research infrastructure to ascertain critically necessary data elements to support device evaluation in urological device use for prostate cancer care and apply natural language processing (NLP) to extract information from clinical reports in a large-scale, multi-institutional database of electronic health records (EHR). The relevant FDA Strategic Priorities of this project is to develop methods and tools to improve and streamline clinical and post-market evaluation of FDA-regulated products. This project will enable impactful, timely, patient-centered active surveillance and comparative device studies in urological oncology for new device-based technologies leveraging the integrated EHRs data from multiple care providers.

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Other projects and plans for the CRN include planning for REDCap data collection at an early stage in the total product lifecycle (TPLC) of these medical devices in the clinical setting. The REDCap data collection site has been built and is hosted at Johns Hopkins Medical Institute. Patient enrollment and data collection will begin at multiple sites and progress will be assessed in late 2019. The established registry will focus on objective performance criteria/objective performance goals as a platform to guide the creation of single arm studies within the SPARED CRN.

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CRN’s accomplishments include core minimum data of the requisite clinical and treatment-related characteristics that were established after four rounds of the Delphi process using validated quality of life instruments and involving urologists, industry leadership, patient advocacy groups, and members of the FDA; manuscript preparation is currently underway.

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