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CUAJ %u2022 FEBRUARY 2025 %u2022 VOLUME 19, ISSUE 2 %u00a9 2025 CANADIAN UROLOGICAL ASSOCIATIONREVIEWINTRODUCTIONProstate cancer (PCa) is the most common malignancy for Canadian men, with approximately 26 000 new cases annually.1 For men with localized PCa, which is the predominant diagnosis, traditional treatment options include active surveillance, radical prostatectomy, or radiation therapy.1In patients with localized PCa randomly assigned to active monitoring, prostatectomy, or radiotherapy, there was no difference in overall or cancer-specific survival with 15-year followup.2 Although a quarter of the actively monitored patients avoided treatment, the group had more clinical progression, metastases, and androgen-deprivation therapy initiation. Conversely, patients radically treated had more urinary incontinence, erectile dysfunction (ED), and/or fecal leakage.2 Thus, radical therapy for intermediate-risk PCa is sometimes %u201covertreatment%u201d causing unnecessary side effects, but it%u2019s difficult to predict which patient is destined to progress. Focal therapy (FT) aims to fill this overtreatment gap by neutralizing prostate tumors while minimizing significant side effects.3 To do so, a target within the prostate is selectively ablated with a defined margin around it, preserving the remaining tissue. Ablation approaches include treating magnetic resonance imaging (MRI)-visible lesions, location of positive biopsies (zonal ablation), or the entire ipsilateral lobe of the prostate (hemi-gland ablation). All INTRODUCTION: Focal therapy is an emerging treatment for localized prostate cancer (PCa). The objectives of this review were to: 1) review how focal therapies are regulated and approved; 2) summarize the scope and quality of the literature regarding safety, efficacy, and side-effects; and 3) outline ongoing clinical trials of focal therapy in Canada.METHODS: Using the PRISMA framework for scoping reviews, we searched PubMed, Embase, and Cochrane from 2021%u20132024, complementing Hopstaken et al%u2019s search up to 2020. We focused on studies reporting functional and oncologic outcomes. Additionally, we examined the FDA database for regulatory details and ongoing trials in Canada via ClinicalTrials.gov.RESULTS: FDA approval for prostate tissue ablation was granted to high-intensity focused ultrasound (HIFU) in 2015 via the de novo pathway; other therapies followed the 510(k) route, citing equivalence to predicate devices. Most studies are in early stages, primarily single-arm, prospective cohort designs. Oncologic outcomes like cancer detection and survival rates, alongside functional data, such as adverse events and erectile function, were assessed. Recurrence-free survival at 48 months ranged from 58%u201392%, pad-free rates were greater than 95%, and rates of new-onset erectile dysfunction were variable, ranging from no change to 50%. Rates of serious adverse events were low, ranging from 0%u201314%. Three Canadian clinical trials are actively enrolling participants, and five private clinics were found offering private HIFU, irreversible electroporation, or transurethral ultrasound ablation.CONCLUSIONS: Focal therapy technologies have gained regulatory approval for prostate tissue ablation, and aside from provincial support for cryoablation in Alberta, are available to Canadians through private payment or clinical trials. Many studies demonstrate promising cancer control and impressive functional outcomes but are limited by their short followup and lack of comparator group. Clinical trial or registry participation should be prioritized to ensure an evidence-based integration into current prostate cancer treatment approaches. ABSTRACTRavi Kumar1, Sangeet Ghai2, Antonio Finelli1, Laurence Klotz1, Adam Kinnaird3, Miles Mannas4,5, Bimal Bhindi6, Rafael Sanchez-Salas7, Maurice Anidjar7, Ardalanejaz Ahmad8, Joseph Chin9, Brant Inman9, Nathan Perlis11Department of Surgery, University of Toronto, Toronto, ON, Canada; 2Department of Medical Imaging, University of Toronto, Toronto, ON, Canada; 3Department of Surgery, University of Alberta, Edmonton, AB, Canada; 4Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; 5Vancouver Prostate Centre, Vancouver, BC, Canada; 6Department of Surgery, University of Calgary, Calgary, AB, Canada; 7Department of Surgery, McGill University, Montreal, QC, Canada; 8Department of Surgery, University of Manitoba, Winnipeg, MB, Canada; 9Department of Surgery, University of Western Ontario, London, ON, Canada Cite as: Kumar R, Ghai S, Finelli A, et al. The use of focal therapy for the treatment of prostate cancer in Canada: Where are we, how did we get here, and where are we going? Can Urol Assoc J 2025;19(2):63-72. http://dx.doi.org/10.5489/cuaj.8888Published online October 7, 2024The use of focal therapy for the treatment of prostate cancer in Canada Where are we, how did we get here, and where are we going? 63