title: Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop.
abstract: OBJECTIVE
  To summarize the discussion that took place at a public workshop, co-sponsored by the U.S. Food and Drug Administration, the American Urological Association, and Society of Urologic Oncology reviewing the current state of the art for partial gland ablation (PGA) for the management of patients with prostate cancer. The purpose of this workshop was to discuss potential indications, current available evidence, and designs for future trials to provide the evidence needed by patients and providers to decide how and when to use PGA.
  
  
  METHODS
  A workshop evaluating PGA for prostate cancer was held in New Orleans, Louisiana, in May 2015. Invited experts representing all stakeholders and attendees discussed the regulatory development of medical products, technology available, potential indications, and designs of trials to evaluate this modality of therapy.
  
  
  RESULTS
  The panel presented the current information on the technologies available to perform PGA, the potential indications, and results of prior consensus conferences. Use of magnetic resonance imaging for patient selection, guide therapy, and follow-up was discussed. Designs of trials to assess PGA outcomes were discussed.
  
  
  CONCLUSIONS
  The general consensus was that currently available technologies are capable of selective ablation with reasonable accuracy, but that criteria for patient selection remain debatable, and long-term cancer control remains to be established in properly designed and well-performed prospective clinical trials. Concerns include the potential for excessive, unnecessary use in patients with low-risk cancer and, conversely, that current diagnostic techniques may underestimate the extent and aggressiveness of some cancers, leading to inadequate treatment.
authors.affiliation: CDER Office of Medical Policy, Food and Drug Administration, Silver Spring, MD. Electronic address: jonathan.jarow@fda.hhs.gov.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom.
authors.forename: Hashim U
authors.initials: HU
authors.lastname: Ahmed
authors.affiliation: Center for Cancer Research, National Cancer Institute, Reston, VA.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Choyke
authors.affiliation: Division of Urologic Oncology, New York University Langone Medical Center, New York City, NY.
authors.forename: Samir S
authors.initials: SS
authors.lastname: Taneja
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York City, NY.
authors.forename: Peter T
authors.initials: PT
authors.lastname: Scardino
mesh_terms: D055011:Ablation Techniques; D006801:Humans; D008297:Male; D008495:Medical Oncology; D011446:Prospective Studies; D011467:Prostate / Q000601:surgery*; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000601:surgery*; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration; D013521:Urologic Surgical Procedures, Male / Q000379:methods; D014572:Urology