This registry represents a multi-institutional effort to prospectively obtain real-world clinical data on prostate-sparing ablative devices including high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and future technologies.
Background of the SPARED Registry
In light of the rapid adoption of novel but unproven technologies for prostate ablation, the need to monitor the safety and effectiveness in the post-market arena is essential. 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. In light of the ever-expanding non-surgical options to treat prostate cancer, the MDEpiNet Science and Infrastructure Center at Weill Cornell, in collaboration with a multi-disciplinary group of stakeholders, has initiated the Study of Prostate Ablation Related Energy Devices (SPARED) Registry. This effort will collect clinical information regarding patient and treatment characteristics as well as outcomes following prostate ablation.
A think-tank meeting was held at the FDA’s White Oak Campus (Silver Spring, MD) on July 22, 2016 and sparked the formation of a distributed registry system to meet these needs. A minimum data set of the requisite clinical and treatment-related characteristics was established via a collaborative DELPHI process involving urologists, industry leadership, patient advocacy groups, and members of the FDA. SPARED is now uniquely positioned to begin data acquisition at an early stage in the total product life cycle of these medical devices in the clinical setting. An FDA-sponsored consortium will be held in September 2017 to create a coordinated registry network system for SPARED and further data collection efforts.
The NEED for the Focal Therapy Registry
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 and clinical trials. The mission of SPARED 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 prevent device-related safety issues. Our collaborative efforts to standardize definitions in the focal therapy literature will allow for outcome comparisons with competing treatment options. 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.
|Dr. Charles Viviano, MD, PhD|
|Dr. Jim Hu, MD, MPH|