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Nat Rev Clin Oncol. 2014 Aug;11(8):482-91. doi: 10.1038/nrclinonc.2014.44. Epub 2014 Apr 22.

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

Author information

  • 1Division of Surgery, University College London, UK.
  • 2Oslo University Hospital, Oslo, Norway.
  • 3St James's Institute of Oncology, Leeds, UK.
  • 4Newcastle University and Freeman Hospital, Newcastle, UK.
  • 5MRC Clinical Trials Unit, London, UK.
  • 6University of Oxford, Oxford, UK.
  • 7Royal Marsden Hospital, London, UK.
  • 8University of Sheffield, Sheffield, UK.
  • 9National Cancer Research Institute, London, UK.
  • 10University of Hull, Hull, UK.
  • 11London School of Hygiene and Tropical Medicine, London, UK.
  • 12Memorial Sloan-Kettering Cancer Center, New York, USA.
  • 13University of Minnesota School of Medicine, Minnesota, USA.


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.

[PubMed - indexed for MEDLINE]
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