Focal High-Intensity Focused Ultrasound vs. Active Surveillance for ISUP Grade 1 Prostate Cancer: Medium-Term Results of a Matched-Pair Comparison.

Only 1 randomized controlled trial has compared focal therapy and active surveillance (AS) for the low-risk prostate cancer (PCa). We investigated whether focal HIFU (fHIFU) yields oncologic advantages over AS for low-risk PCa.

We included 2 non-randomized prospective series of 132 (fHIFU) and 421 (AS) consecutive patients diagnosed with ISUP 1 PCa between 2008 and 2018. A matched pair analysis was performed to decrease potential bias. Study main outcomes were freedom from radical treatment (RT) or androgen-deprivation therapy (ADT), treatment-free survival (TFS), time to metastasis, and overall survival (OS).

Median fHIFU follow-up was 50 months (interquartile range, 29-84 months). Among matched variables, no major differences were recorded except for AS having more suspicious digital rectal examination findings (P = .0074) and recent enrollment year (P = .0005). Five-year intervention-free survival from RT or ADT was higher for the fHIFU cohort (67.4% vs. 53.8%; P = .0158). Time to treatment was approximately 10 months shorter for AS than for fHIFU (time to RT, P = .0363; time to RT or ADT, P = .0156; time to any treatment, P = .0319). No differences were found in any-TFS (fHIFU, 61.4% vs. AS, 53.8%; P = .2635), OS (fHIFU, 97% vs. AS, 97%; P = .9237), or metastasis (n = 0 in fHIFU and n = 2 in AS; P = .4981). Major complications (≥ Clavien 3) were rare (n = 4), although 36.4% of men experienced complications. No relevant changes were noted in continence (P = .3949).

At a 4-year median follow-up, fHIFU for mainly low-risk PCa (ISUP grade 1) is safe, may decrease the need for radical treatment or ADT and may allow longer time to treatment compared to AS. Nonetheless, no advantages are seen in PCa progression and/or death (OS).

Clinical genitourinary cancer. 2022 Jun 30 [Epub ahead of print]

Giancarlo Marra, Timo Soeterik, Davide Oreggia, Rafael Tourinho-Barbosa, Marco Moschini, Armando Stabile, Claudia Filippini, Harm He van Melick, Roderick Cn van den Bergh, Paolo Gontero, Caio Pasquali, Petr Macek, Nathalie Cathala, Rafael Sanchez-Salas, Xavier Cathelineau

Department of Urology, Institut Mutualiste Montsouris and Université Paris Descartes, Paris, France; Department of Surgical Sciences, University of Turin and Città della Salute e della Scienza, Turin Italy; Department of Urology and Clinical Research Group on predictive onco-urology, APHP. Sorbonne University, Paris, France. Electronic address: ., Department of Urology, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands., Department of Urology, Institut Mutualiste Montsouris and Université Paris Descartes, Paris, France., Department of Surgical Sciences, University of Turin and Città della Salute e della Scienza, Turin Italy.

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