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.
Bibliographical noteFunding Information:
supported by a research grant provided by the Medical Research Council (UK) and logistical support was provided by the Pelican Cancer Foundation charity. We had no commercial support. In total, 60 participants attended from multidisciplinary backgrounds, with five patient representatives, three representatives from the major stakeholder charities, three nurses, six oncologists, 29 urologists, three radiologists and 11 representatives of clinical epidemiology, health economics, statistics and clinical trials (a complete list of participants is provided in Supplementary Table 1 online). The first half of the day involved short presentations (each followed by discussions) on current errors and potential solutions to the localized prostate cancer pathway, RCTs that have evaluated different treatment strategies for localized prostate cancer, challenges in delivering large multicentre RCTs, the role of multiparametric MRI (mpMRI) in prostate cancer diagnosis and follow-up monitoring, the current state-of-the-art of focal therapies, novel RCT designs and integrating comparative effectiveness research into electronic healthcare systems.
H.U.A. has received research funding from the following companies: Advanced Medical Diagnostics, GlaxoSmithKline and Sonacare. M.E. has received research funding from the following companies: Advanced Medical Diagnostics, GlaxoSmithKline, Steba Biotech and Sonacare. M.E. is a paid consultant for GlaxoSmithKline, Steba Biotech and Sonacare. M.E. is a director on the board of and has share options in Nuada Medical. The other authors declare no competing interests.