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In 2002 Onik et al. (1) first coined the term male lumpectomy, which evolved into the concept of focal therapy for prostate cancer: a prostate-sparing treatment option with the potential for effective cancer control and improved functional outcomes.
In 2009 Lindner et al. (2) presented a phase 1 trial featuring the three pillars of focal therapy for the treatment of prostatic carcinoma: a comprehensive approach including planning of treatment with both magnetic resonance and three-dimensional ultrasound imaging; ablative treatment with interstitial laser technology; and treatment control with contrast-enhanced ultrasound, magnetic resonance, and prostatic biopsies. Twelve patients with biopsyproven low-risk prostate cancer were treated with this approach, and the results reported showed adequate clinical, histological, and imaging outcomes with minimal adverse effects.
Focal ablation of prostate cancer techniques have been continuously evolving based on the adoption of a plethora of technology, and the middle ground option between active surveillance and radical options has been embraced by several referral teams around the world. For these cases, the urological approach goes much further than the selection of a patient’s most appropriate therapeutic option. That is, if a patient is being considered for focal therapy, the physician should have in mind, first, imageguided planning, second, the available options for ablation, and third, assessment of treatment efficacy.
The recent introduction of focal therapy begs the question of how to objectively evaluate and validate the technological tools that support an approach aimed at tackling the paradigm of white (active surveillance) or black (most radical options) in prostate cancer.
The recent publication from Valerio et al. (3) represents a timely analysis of how technology should be adopted in focal therapy in order to overcome its most controversial times.
The authors state the need for change in the prostate cancer pathway from screening and diagnosis to treatment, and how with the deployment of high-quality, prospective, single-arm data studies the field could actually move forward toward its tipping point.
The manuscript highlights the essential role of imaging in the target detection or image-guided planning of treatment and how multiparametric magnetic resonance
imaging represents the best performer in prostatic evaluation. Valerio et al. mention The Standards for Reporting of Diagnostic Accuracy (STARD) as the path to follow in the future to provide Level 1 Evidence of superiority of a novel diagnostic modality. A clear example is provided to the reader through the explanations related to the Prostate MRI Imaging Study (PROMIS).
The issue of target ablation is also featured in the manuscript, and the Idea, Development, Exploration, Assessment, and Long-term study (IDEAL) guidelines are presented as the most suitable option to obtain validation for surgical innovations. The authors provide timely recommendations for focal therapy in terms of patient population (intermediate-risk and low-volume, organconfined, high-risk disease), definition of intervention (any tissue-sparing approach, either focal or subtotal ablation), eventual comparator (no tissue-sparing technique: more radical approaches), and the definition of outcomes or treatment control (local cancer control measures and toxicity).
Finally, the authors present different trial designs that could be used to evaluate the intervention, including cohort single-arm studies and comparative effectiveness research.
Above all, the fruit one harvests from the tree in the Valerio et al. study is that finally the overused phrase: "Further prospective trials are warranted or required to demonstrate the effectiveness of this technique," becomes a real statement of academic inspiration.