title: 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.
authors.affiliation: Division of Surgery, University College London, UK.
authors.forename: Hashim U
authors.initials: HU
authors.lastname: Ahmed
authors.affiliation: Oslo University Hospital, Oslo, Norway.
authors.forename: Viktor
authors.initials: V
authors.lastname: Berge
authors.affiliation: St James's Institute of Oncology, Leeds, UK.
authors.forename: David
authors.initials: D
authors.lastname: Bottomley
authors.affiliation: St James's Institute of Oncology, Leeds, UK.
authors.forename: William
authors.initials: W
authors.lastname: Cross
authors.affiliation: Newcastle University and Freeman Hospital, Newcastle, UK.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Heer
authors.affiliation: MRC Clinical Trials Unit, London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Kaplan
authors.affiliation: University of Oxford, Oxford, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Leslie
authors.affiliation: Royal Marsden Hospital, London, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Parker
authors.affiliation: University of Sheffield, Sheffield, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Relton
authors.affiliation: National Cancer Research Institute, London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Stephens
authors.affiliation: MRC Clinical Trials Unit, London, UK.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Sydes
authors.affiliation: University of Hull, Hull, UK.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Turnbull
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: van der Meulen
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Vickers
authors.affiliation: University of Minnesota School of Medicine, Minnesota, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Wilt
authors.affiliation: Division of Surgery, University College London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Emberton
mesh_terms: D018450:Disease Progression; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
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