Focal high‐intensity focused ultrasound therapy for localized prostate cancer: An interim analysis of the multinational FASST study

Author:

Ladjevardi Sam1,Ebner Anna23ORCID,Femic Aleksandar1,Huebner Nicolai A.456,Shariat Shahrokh F.478910,Kraler Simon1112ORCID,Kubik‐Huch Rahel A.13ORCID,Ahlman Rafaele C.1,Häggman Michael1,Hefermehl Lukas J.2

Affiliation:

1. Department of Urology University of Uppsala Uppsala Sweden

2. Department of Urology Cantonal Hospital Baden Baden Switzerland

3. Department of Urology University Hospital Zurich Zurich Switzerland

4. Department of Urology Comprehensive Cancer Center, Medical University of Vienna Vienna Austria

5. Working Group for Diagnostic imaging in Urology (ABDU) Austrian association of Urology (ÖGU) Vienna Austria

6. Department of urology University of California Davis Sacramento California USA

7. Karl Landsteiner Institute of Urology and Andrology Vienna Austria

8. Department of Urology, Second Faculty of Medicine Charles University Prague Czech Republic

9. Division of Urology Hourani Center for Applied Scientific Research, Al‐Ahliyya Amman University Amman Jordan

10. Department of Urology Weill Cornell Medical College New York New York USA

11. Center for Molecular Cardiology University of Zurich Schlieren Switzerland

12. Department of Internal Medicine Cantonal Hospital Baden Baden Switzerland

13. Department of Radiology Cantonal Hospital Baden Baden Switzerland

Abstract

AbstractBackgroundHigh‐intensity focused ultrasound (HIFU) emerged as a novel approach for the treatment of localized prostate cancer (PCa). However, prospective studies on HIFU‐related outcomes and predictors of treatment failure (TF) remain scarce.Materials and MethodsWe conducted a multinational prospective cohort study among patients undergoing HIFU therapy for localized, low‐ to intermediate‐risk PCa. Follow‐up data on serial prostate specific antigen (PSA), multi‐parametric magnetic resonance imaging (mpMRI), targeted/systematic biopsies, adverse events and functional outcomes were collected. The primary endpoint was TF, defined as histologically confirmed PCa requiring whole‐gland salvage treatment. Uni‐ and multi‐variable adjusted hazard ratios (HRs) were calculated using Cox proportional hazard regression models.ResultsAt baseline, mean (standard deviation) age was 64.14 (7.19) years, with the majority of patients showing T‐stage 1 (73.9%) and International Society of Urological Pathology grading system Grade 2 (58.8%). PSA nadir (median, 1.70 ng/mL) was reached after 6 months. Of all patients recruited, 16% had clinically significant PCa, as confirmed by biopsy, of which 13.4% had TF. Notably, T‐stage and number of positive cores at initial biopsy were independent predictors of TF during follow‐up (HR [95% CI] 1.27 [1.02–1.59] and 5.02 [1.80–14.03], respectively). Adverse events were minimal (17% and 8% early and late adverse events, respectively), with stable or improved functional outcomes in the majority of patients.ConclusionsThis interim analysis of a multinational study on HIFU therapy for the management of low‐to‐intermediate‐risk PCa reveals good functional outcomes, minimal adverse events and low incidence of TF over the short‐term. Data on long‐term outcomes, specifically as it relates to oncological outcomes, are awaited eagerly.

Publisher

Wiley

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