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Can we deliver randomized trials of focal therapy in prostate cancer?

Ahmed H.U. Berge V. Bottomley D. Cross W. Heer R. Kaplan R. Leslie T. Parker C. Relton C. Stephens R. Sydes M.R. Turnbull L. van der Meulen J. Vickers A. Wilt T. Emberton M.

Comment by Henk van der Poel

Focal therapy: from “male lumpectomy” to proven standard therapy seems a long way. So far no convincing large randomized studies have defined the place of focal therapy in localized prostate cancer management. One third of men with low grade prostate cancer will harbor higher grade disease. Active surveillance programs show clinical progression defined by several criteria to occur in up to 40% of men in the early years of management. Ahmed and Emberton in Nat Rev Clin Oncology suggest a clinical trial comparing focal therapy against whole gland surgery or radiotherapy. A randomized trial comparing focal hemiablation of the prostate applying vascular targeted photodynamic therapy using WST011 against active surveillance has completed accrual and 2 year biopsy follow up data are expected in 2015.

Nature Reviews Clinical Oncology 2014 Apr 22. doi: 10.1038/nrclinonc.2014.44. [Epub ahead of print]


Tissue-preserving focal therapies, such as brachytherapy, cryotherapy, high-intensity focused ultrasound and photodynamic therapy, aim to target individual cancer lesions rather than the whole prostate. These treatments have emerged as potential interventions for localized prostate cancer to reduce treatment-related adverse-effects associated with whole-gland treatments, such as radical prostatectomy and radiotherapy. In this article, the Prostate Cancer RCT Consensus Group propose that a novel cohort-embedded randomized controlled trial (RCT) would provide a means to study men with clinically significant localized disease, which we defined on the basis of PSA level ((less-than or equal to)15 ng/ml or (less-than or equal to)20 ng/ml), Gleason grade (Gleason pattern (less-than or equal to)4 + 4 or (less-than or equal to)4 + 3) and stage ((less-than or equal to)cT2cN0M0). This RCT should recruit men who stand to benefit from treatment, with the control arm being whole-gland surgery or radiotherapy. Composite outcomes measuring rates of local and systemic salvage therapies at 3-5 years might best constitute the basis of the primary outcome on which to change practice.