Abstract
Background
The place of focal therapy in prostate cancer management requires further evaluation within randomized comparative clinical trials.
Methods
This review article discusses the place of focal therapy and asks whether it is an alternative to active surveillance or radical therapy. This question therefore is at the heart of whether this proposed paradigm shift should be delivered with the intent of cure or cancer control.
Results
For such trials to report on outcomes that have meaningful utility in the clinic, it is necessary to discuss whether focal ablation should be delivered with intent to eradicate all cancer foci (‘cure’) or ablate all clinically significant lesions with surveillance of all remaining tissue (benign or harboring clinically insignificant cancer). While the former will inevitably mean that fewer men will be appropriate for focal therapy were it to become standard care, it is the safest approach. The latter strategy will open focal therapy to the majority of men with low- to intermediate-risk disease with the potential of offering a treatment strategy that treats important cancer while preserving function with a high degree of probability.
Conclusion
A pragmatic randomized controlled clinical in which focal therapy is randomized against standard of care may be feasible. The pragmatic nature of such a trial would allow eligibility criteria, localization of cancer to reflect local practice (novel imaging and transrectal biopsy or template prostate mapping), and the focal intervention (ablative modality, intent to ablate all cancer foci or all clinically significant foci) to be kept broad to reflect clinical practice. Further, it would satisfy individual equipoise by allowing either active surveillance or radical therapy in the standard care arm, to be decided on by patient and physician.
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Acknowledgments
Mark Emberton is in part funded by the NIHR UCLH/UCL Comprehensive Biomedical Research Centre. Hashim Ahmed is funded by the Medical Research Council. Hashim Ahmed and Mark Emberton receive research funding from Pelican Cancer Foundation UK, The Prostate Research Campaign UK, the Prostate Cancer Research Centre, Prostate Cancer Research Foundation, and St Peters Trust for work in focal therapy and imaging of prostate cancer. The authors receive research funding, travel grants for conferences, and medical advisory fees from Steba Biotech, France (manufacturers of TOOKAD, a photodynamic agent used in prostate cancer therapy) and USHIFU (manufacturers and distributors of Sonabate500 HIFU device). None of the funding sources had any role in the writing of this article.
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Ahmed, H.U., Emberton, M. Benchmarks for success in focal therapy of prostate cancer: cure or control?. World J Urol 28, 577–582 (2010). https://doi.org/10.1007/s00345-010-0590-y
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DOI: https://doi.org/10.1007/s00345-010-0590-y