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Updated: Feb 16, 2026
11:07
Focal Laser Ablation of Prostate Cancer: An Office Procedure
Published on: March 30, 2021
8.5K
Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.
Ron Golan1, Adrien Bernstein1, Art Sedrakyan2
1Department of Urology, New York Presbyterian-Weill Cornell Medical College, New York, New York.
The Journal of Urology
|January 9, 2018
Summary
A coordinated registry network can collect real-world evidence on prostate ablation technologies. Experts agreed on key data elements for assessing patient outcomes and treatment effectiveness in this emerging field.
Area of Science:
- Urology
- Oncology
- Medical Devices
Background:
- Real-world evidence is crucial for evaluating novel prostate ablation technologies.
- Prospective, multicenter registries offer a practical approach to data collection.
Purpose of the Study:
- To discuss the role and feasibility of a coordinated registry network for prostate ablation technologies.
- To identify essential data elements for assessing new and existing ablation devices.
Main Methods:
- A multiround Delphi consensus approach involving 15 expert urologists, FDA representatives, and industry leaders.
- Input gathered through consecutive rounds and conference calls to achieve consensus.
- Review and supplementation of registry elements with FDA common study metrics.
Main Results:
- Consensus reached on capturing patient demographics, treatment details, oncologic and functional outcomes, and complications.
- Selection of validated questionnaires for patient-reported outcomes (IIEF-5, I-PSS, EPIC-26, MSHQ-EjD).
- Agreement on 12-month follow-up multiparametric MRI and biopsy, with additional assessments as clinically indicated.
Conclusions:
- A national prostate ablation registry network is vital for practice pattern and outcomes data in the US.
- Multi-stakeholder consensus identifies critical elements for evaluating energy modalities and devices.
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