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

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 (≤ 15 ng/ml or ≤ 20 ng/ml), Gleason grade (Gleason pattern ≤ 4 + 4 or ≤ 4 + 3) and stage (≤ 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.

Written by:
Ahmed HU, Berge V, Bottomley D, Cross W, Heer R, Kaplan R, Leslie T, Parker C, Relton C, Stephens R, Sydes MR, Turnbull L, van der Meulen J, Vickers A, Wilt T, Emberton M.   Are you the author?
Division of Surgery, University College London, UK; Oslo University Hospital, Oslo, Norway; St James's Institute of Oncology, Leeds, UK; Newcastle University and Freeman Hospital, Newcastle, UK; MRC Clinical Trials Unit, London, UK; University of Oxford, Oxford, UK; Royal Marsden Hospital, London, UK; University of Sheffield, Sheffield, UK; National Cancer Research Institute, London, UK; University of Hull, Hull, UK; London School of Hygiene and Tropical Medicine, London, UK; Memorial Sloan-Kettering Cancer Center, New York, USA; University of Minnesota School of Medicine, Minnesota, USA.

Reference: Nat Rev Clin Oncol. 2014 Apr 22. Epub ahead of print.
doi: 10.1038/nrclinonc.2014.44

 
PubMed Abstract
PMID: 24751803

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