TY - JOUR
T1 - Partial gland ablation for prostate cancer
T2 - Report of a food and drug administration, American urological association, and society of urologic oncology public workshop
AU - Jarow, Jonathan P.
AU - Ahmed, Hashim U.
AU - Choyke, Peter L.
AU - Taneja, Samir S.
AU - Scardino, Peter T.
N1 - Funding Information:
Financial Disclosure: Hashim U. Ahmed received clinical trial funding from Sonacare Inc., and also funding for conference travel and honoraria for lectures at courses organized by the said company. He is currently a paid proctor for HIFU. He also received current clinical trial funding from Trod Medical and Sophiris Biocorp. He is previous Consultant for protocol writing at Steba Biotech and is current Consultant for protocol writing for Exact Imaging. He previously received resources from Angiodynamics Inc. through free device and probe use within investigator-led clinical trial. At present, he received resources from Hitachi through free probe use within investigator led clinical trial. Samir S. Taneja is a paid consultant to Hitachi-Aloka and a study investigator for Steba-Biotech and Trod Medical. He received funding from Biobot and Hitachi-Aloka. The remaining authors declare that they have no relevant financial interests.
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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. Conclusion 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.
AB - 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. Conclusion 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.
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U2 - 10.1016/j.urology.2015.11.018
DO - 10.1016/j.urology.2015.11.018
M3 - Article
C2 - 26621480
AN - SCOPUS:84960439297
SN - 0090-4295
VL - 88
SP - 8
EP - 13
JO - Urology
JF - Urology
ER -