With the goal of collecting high-quality clinical data on hundreds of patients, a consortium of renowned medical institutions is introducing the Focal Robotic Ultrasound Ablation (FoR-UsA) Registry. The new database will track baseline and follow-up information on patients undergoing partial-gland ablation of the prostate using the Ablatherm Robotic high-intensity focused ultrasound (HIFU) device, manufactured by EDAP TMS. Participating organizations include the University of Miami Miller School of Medicine, Weill Cornell-Houston Methodist Hospital, Cleveland Clinic, Duke University, and the University of Southern California.
The FoR-UsA Registry is the first in the United States that specifically collects data on patients who have had HIFU focal therapy for prostate tissue ablation, giving urologists greater access to short- and long-term HIFU outcomes. The registry also holds the potential for the FDA, which cleared HIFU for prostate tissue ablation in 2015, to reevaluate the technology in the future for a prostate cancer indication. Likewise, health insurance reimbursements on a wider scale are also possible with a registry documenting HIFU data from North American patients.
"Our goal is to have one comprehensive focal therapy HIFU registry in the US that will enable us to better define the role of HIFU in the spectrum of treatment modalities for patients with prostate conditions," says Dipen Parekh, MD, chairman and a professor of the department of urology at the University of Miami, who is the principal investigator for the FoR-UsA Registry.
Documenting Long-Term Outcomes
Led by the University of Miami, patient data will be published in the registry by 2020 and again in five-year intervals, at the five-, 10-, and 15-year marks to document long-term patient outcomes. That data may also support future clinical evaluations for HIFU as a first-line prostate cancer treatment.
The FoR-UsA Registry will record data including patient demographics, clinical characteristics, and, most importantly, collect valuable data on cancer control and functional outcomes for patients undergoing HIFU. Data on side effects and complication rates will also be collected. The registry puts answers about HIFU at participating researchers' disposal and will provide greater insight about how HIFU is best used to benefit patients.
As part of an internal review board (IRB)-approved protocol, all patients in the registry will undergo a follow-up biopsy within six to 12 months from the time of the HIFU ablation to assess cancer control. Standard questionnaires regarding urinary and sexual function will also be tracked, since international studies have shown that patients undergoing HIFU procedures report lower rates of incontinence and impotence compared with other treatments.
Urologists from the participating institutions must have their protocols approved by their IRB or Independent Ethics Committee. Once the legal and administrative approvals are complete, they will be able to enter information on their own patients and assess their individual focal therapy results in comparison with a larger cohort of patients around the United States.
The FoR-UsA Registry is based on REDCap technology, software for designing clinical and translational research databases originally created by Vanderbilt University and funded, in part, by the National Institutes of Health. EDAP TMS, manufacturer and distributor of the Ablatherm Robotic HIFU device, is providing financial support for the FoR-UsA Registry. The company established the @-Registry in Europe 10 years ago, which currently includes data on more than 10,000 HIFU patients.— Source: EDAP TMS