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Focal high-intensity focused ultrasound therapy for localized prostate cancer: An interim analysis of the multinational FASST study
S. Ladjevardi, A. Ebner, A. Femic, NA. Huebner, SF. Shariat, S. Kraler, RA. Kubik-Huch, RC. Ahlman, M. Häggman, LJ. Hefermehl
Language English Country England, Great Britain
Document type Journal Article, Multicenter Study
PubMed
38445798
DOI
10.1111/eci.14192
Knihovny.cz E-resources
- MeSH
- High-Intensity Focused Ultrasound Ablation methods MeSH
- Cohort Studies MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiparametric Magnetic Resonance Imaging MeSH
- Prostatic Neoplasms * therapy pathology MeSH
- Treatment Failure MeSH
- Proportional Hazards Models MeSH
- Prospective Studies MeSH
- Prostate-Specific Antigen * metabolism blood MeSH
- Aged MeSH
- Neoplasm Grading MeSH
- Ultrasound, High-Intensity Focused, Transrectal MeSH
- Salvage Therapy methods MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
BACKGROUND: High-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 METHODS: We 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. RESULTS: At 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. CONCLUSIONS: This 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.
Center for Molecular Cardiology University of Zurich Schlieren Switzerland
Department of Internal Medicine Cantonal Hospital Baden Baden Switzerland
Department of Radiology Cantonal Hospital Baden Baden Switzerland
Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic
Department of Urology Cantonal Hospital Baden Baden Switzerland
Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria
Department of Urology University Hospital Zurich Zurich Switzerland
Department of urology University of California Davis Sacramento California USA
Department of Urology University of Texas Southwestern Dallas Texas USA
Department of Urology University of Uppsala Uppsala Sweden
Department of Urology Weill Cornell Medical College New York New York USA
Karl Landsteiner Institute of Urology and Andrology Vienna Austria
Working Group for Diagnostic imaging in Urology Vienna Austria
References provided by Crossref.org
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- $a BACKGROUND: High-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 METHODS: We 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. RESULTS: At 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. CONCLUSIONS: This 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.
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