SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer

Michael D. Gross, Art Sedrakyan, Fernando J. Bianco, Peter R. Carroll, Timothy J. Daskivich, Scott E. Eggener, Behfar Ehdaie, Benjamin Fisher, Michael A. Gorin, Bradley Hunt, Hongying Jiang, Eric A. Klein, Danica Marinac-Dabic, Jeffrey S. Montgomery, Thomas J. Polascik, Alan M. Priester, Ardeshir R. Rastinehad, Charles J. Viviano, James S. Wysock, Jim C. Hu

Research output: Contribution to journalArticle

Abstract

PURPOSE: The SPARED CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network) is a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer. MATERIALS AND METHODS: We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for partial gland ablation, focusing on patient selection, surgical planning, followup, study design and appropriate comparators in terms of adverse events and cancer control outcomes. We summarize salient points from experts in urology, oncology and epidemiology that were presented and discussed in an open forum. RESULTS: Given the challenges in achieving patient and physician equipoise to perform a randomized trial, as well as an inherent paradigm shift when comparing partial gland ablation (inability to assess prostate specific antigen recurrence) to whole gland treatments, the group focused on objective performance criteria and goals as a platform to guide the creation of single arm studies in the SPARED CRN. CONCLUSIONS: This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.

Original languageEnglish (US)
Pages (from-to)952-958
Number of pages7
JournalThe Journal of urology
Volume202
Issue number5
DOIs
StatePublished - Nov 1 2019

Fingerprint

Patient Selection
Prostatic Neoplasms
Equipment and Supplies
United States Food and Drug Administration
Epidemiology
Public-Private Sector Partnerships
Urology
Drug Combinations
Prostate-Specific Antigen
Registries
Prostate
Technology
Physicians
Safety
Education
Recurrence
Neoplasms
Therapeutics

Keywords

  • ablation techniques
  • biomedical technology
  • patient outcome assessment
  • prostatic neoplasms
  • registries

ASJC Scopus subject areas

  • Urology

Cite this

Gross, M. D., Sedrakyan, A., Bianco, F. J., Carroll, P. R., Daskivich, T. J., Eggener, S. E., ... Hu, J. C. (2019). SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer. The Journal of urology, 202(5), 952-958. https://doi.org/10.1097/JU.0000000000000357

SPARED Collaboration : Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer. / Gross, Michael D.; Sedrakyan, Art; Bianco, Fernando J.; Carroll, Peter R.; Daskivich, Timothy J.; Eggener, Scott E.; Ehdaie, Behfar; Fisher, Benjamin; Gorin, Michael A.; Hunt, Bradley; Jiang, Hongying; Klein, Eric A.; Marinac-Dabic, Danica; Montgomery, Jeffrey S.; Polascik, Thomas J.; Priester, Alan M.; Rastinehad, Ardeshir R.; Viviano, Charles J.; Wysock, James S.; Hu, Jim C.

In: The Journal of urology, Vol. 202, No. 5, 01.11.2019, p. 952-958.

Research output: Contribution to journalArticle

Gross, MD, Sedrakyan, A, Bianco, FJ, Carroll, PR, Daskivich, TJ, Eggener, SE, Ehdaie, B, Fisher, B, Gorin, MA, Hunt, B, Jiang, H, Klein, EA, Marinac-Dabic, D, Montgomery, JS, Polascik, TJ, Priester, AM, Rastinehad, AR, Viviano, CJ, Wysock, JS & Hu, JC 2019, 'SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer', The Journal of urology, vol. 202, no. 5, pp. 952-958. https://doi.org/10.1097/JU.0000000000000357
Gross, Michael D. ; Sedrakyan, Art ; Bianco, Fernando J. ; Carroll, Peter R. ; Daskivich, Timothy J. ; Eggener, Scott E. ; Ehdaie, Behfar ; Fisher, Benjamin ; Gorin, Michael A. ; Hunt, Bradley ; Jiang, Hongying ; Klein, Eric A. ; Marinac-Dabic, Danica ; Montgomery, Jeffrey S. ; Polascik, Thomas J. ; Priester, Alan M. ; Rastinehad, Ardeshir R. ; Viviano, Charles J. ; Wysock, James S. ; Hu, Jim C. / SPARED Collaboration : Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer. In: The Journal of urology. 2019 ; Vol. 202, No. 5. pp. 952-958.
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AU - Carroll, Peter R.

AU - Daskivich, Timothy J.

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