دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Focal high-intensity focused ultrasound therapy for localized prostate cancer: An interim analysis of the multinational FASST study.
المؤلفون: Ladjevardi S; Department of Urology, University of Uppsala, Uppsala, Sweden., Ebner A; Department of Urology, Cantonal Hospital Baden, Baden, Switzerland.; Department of Urology, University Hospital Zurich, Zurich, Switzerland., Femic A; Department of Urology, University of Uppsala, Uppsala, Sweden., Huebner NA; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.; Working Group for Diagnostic imaging in Urology (ABDU), Austrian association of Urology (ÖGU), Vienna, Austria.; Department of urology, University of California Davis, Sacramento, California, USA., Shariat SF; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria.; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic.; Division of Urology, Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan.; Department of Urology, Weill Cornell Medical College, New York, New York, USA.; Department of Urology, University of Texas Southwestern, Dallas, Texas, USA., Kraler S; Center for Molecular Cardiology, University of Zurich, Schlieren, Switzerland.; Department of Internal Medicine, Cantonal Hospital Baden, Baden, Switzerland., Kubik-Huch RA; Department of Radiology, Cantonal Hospital Baden, Baden, Switzerland., Ahlman RC; Department of Urology, University of Uppsala, Uppsala, Sweden., Häggman M; Department of Urology, University of Uppsala, Uppsala, Sweden., Hefermehl LJ; Department of Urology, Cantonal Hospital Baden, Baden, Switzerland.
المصدر: European journal of clinical investigation [Eur J Clin Invest] 2024 Jun; Vol. 54 (6), pp. e14192. Date of Electronic Publication: 2024 Mar 06.
نوع المنشور: Journal Article; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: England NLM ID: 0245331 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2362 (Electronic) Linking ISSN: 00142972 NLM ISO Abbreviation: Eur J Clin Invest Subsets: MEDLINE
أسماء مطبوعة: Publication: Oxford : Wiley
Original Publication: Berlin, New York, Springer-Verlag, on behalf of the European Society for Clinical Investigation.
مواضيع طبية MeSH: Prostatic Neoplasms*/therapy , Prostatic Neoplasms*/pathology , Prostate-Specific Antigen*/metabolism , Prostate-Specific Antigen*/blood, Humans ; Male ; Middle Aged ; Aged ; Prospective Studies ; Ultrasound, High-Intensity Focused, Transrectal ; Treatment Failure ; Proportional Hazards Models ; Salvage Therapy/methods ; High-Intensity Focused Ultrasound Ablation/methods ; Multiparametric Magnetic Resonance Imaging ; Neoplasm Grading ; Cohort Studies
مستخلص: 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.
(© 2024 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)
References: Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209‐249. doi:10.3322/caac.21660.
Fitzmaurice C, Allen C, Barber RM, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability‐adjusted life‐years for 32 cancer groups, 1990 to 2015: a systematic analysis for the global burden of disease study. JAMA Oncol. 2017;3(4):524‐548.
Wilt TJ, Vo TN, Langsetmo L, et al. Radical prostatectomy or observation for clinically localized prostate cancer: extended follow‐up of the prostate cancer intervention versus observation trial (PIVOT). Eur Urol. 2020;77(6):713‐724. doi:10.1016/j.eururo.2020.02.009.
Mottet N, van den Bergh RCN, Briers E, et al. EAU‐EANM‐ESTRO‐ESUR‐SIOG guidelines on prostate cancer—2020 update. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol. 2021;79(2):243‐262. doi:10.1016/j.eururo.2020.09.042.
Hamdy FC, Donovan JL, Lane JA, et al. 10‐year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med. 2016;375(15):1415‐1424. doi:10.1056/nejmoa1606220.
Hamdy FC, Donovan JL, Lane JA, et al. Fifteen‐year outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med. 2023;388(17):1547‐1558. doi:10.1056/nejmoa2214122.
Valerio M, Cerantola Y, Eggener SE, et al. New and established Technology in Focal Ablation of the prostate: a systematic review. Eur Urol. 2017;71(1):17‐34. doi:10.1016/j.eururo.2016.08.044.
Shah TT, Reddy D, Peters M, et al. Focal therapy compared to radical prostatectomy for non‐metastatic prostate cancer: a propensity score‐matched study. Prostate Cancer Prostatic Dis. 2021;24(2):567‐574. doi:10.1038/s41391-020-00315-y.
Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Fütterer JJ, Rovers MM. An updated systematic review on focal therapy in localized prostate cancer: what has changed over the past 5 years? Eur Urol. 2022;81(1):5‐33. doi:10.1016/j.eururo.2021.08.005.
Ahmed HU. The index lesion and the origin of prostate cancer. N Engl J Med. 2009;361(17):1704‐1706. doi:10.1056/nejmcibr0905562.
Ahmed HU, Dickinson L, Charman S, et al. Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study. Eur Urol. 2015;68(6):927‐936. doi:10.1016/j.eururo.2015.01.030.
Fiard G, Giganti F. How MRI is changing prostate cancer management: a focus on early detection and active surveillance. Prog Urol. 2022;32:6S19‐6S25. doi:10.1016/S1166-7087(22)00171-3.
Bates AS, Ayers J, Kostakopoulos N, et al. A systematic review of focal ablative therapy for clinically localised prostate cancer in comparison with standard management options: limitations of the available evidence and recommendations for clinical practice and further research. Eur Urol Oncol. 2021;4(3):405‐423. doi:10.1016/j.euo.2020.12.008.
Donaldson IA, Alonzi R, Barratt D, et al. Focal therapy: patients, interventions, and outcomes—a report from a consensus meeting. Eur Urol. 2015;67(4):771‐777. doi:10.1016/j.eururo.2014.09.018.
Chaussy CG, Thüroff S. High‐intensity focused ultrasound for the treatment of prostate cancer: a review. J Endourol. 2017;31(S1):S30‐S37. doi:10.1089/end.2016.0548.
Dellabella M, Branchi A, Di Rosa M, et al. Oncological and functional outcome after partial prostate HIFU ablation with Focal‐One®: a prospective single‐center study. Prostate Cancer Prostatic Dis. 2021;24(4):1189‐1197. doi:10.1038/s41391-021-00390-9.
Crouzet S, Rebillard X, Chevallier D, et al. Multicentric oncologic outcomes of high‐intensity focused ultrasound for localized prostate cancer in 803 patients. Eur Urol. 2010;58(4):559‐566. doi:10.1016/j.eururo.2010.06.037.
Rischmann P, Gelet A, Riche B, et al. Focal high intensity focused ultrasound of unilateral localized prostate cancer: a prospective multicentric hemiablation study of 111 patients. Eur Urol. 2017;71(2):267‐273. doi:10.1016/j.eururo.2016.09.039.
Abreu AL, Peretsman S, Iwata A, et al. High intensity focused ultrasound hemigland ablation for prostate cancer: initial outcomes of a United States series. J Urol. 2020;204(4):741‐747. doi:10.1097/JU.0000000000001126.
Guillaumier S, Peters M, Arya M, et al. A multicentre study of 5‐year outcomes following focal therapy in treating clinically significant nonmetastatic prostate cancer. Eur Urol. 2018;74(4):422‐429. doi:10.1016/j.eururo.2018.06.006.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications. Ann Surg. 2004;240(2):205‐213. doi:10.1097/01.sla.0000133083.54934.ae.
Barry MJ, Fowler FJ, O'Leary MP, et al. The American urological association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992;148(5 Part 1):1549‐1557. doi:10.1016/S0022-5347(17)36966-5.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49(6):822‐830. doi:10.1016/S0090-4295(97)00238-0.
Chang P, Szymanski KM, Dunn RL, et al. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011;186(3):865‐872. doi:10.1016/j.juro.2011.04.085.
Reddy D, Peters M, Shah TT, et al. Cancer control outcomes following focal therapy using high‐intensity focused ultrasound in 1379 men with nonmetastatic prostate cancer: a multi‐institute 15‐year experience. Eur Urol. 2022;81(4):407‐413. doi:10.1016/j.eururo.2022.01.005.
Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367(3):203‐213. doi:10.1056/nejmoa1113162.
Roach M, Hanks G, Thames H, et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG‐ASTRO Phoenix consensus conference. Int J Radiat Oncol Biol Phys. 2006;65(4):965‐974. doi:10.1016/j.ijrobp.2006.04.029.
Blana A, Brown SCW, Chaussy C, et al. High‐intensity focused ultrasound for prostate cancer: comparative definitions of biochemical failure. BJU Int. 2009;104(8):1058‐1062. doi:10.1111/j.1464-410X.2009.08518.x.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344‐349. doi:10.1016/j.jclinepi.2007.11.008.
Hoffman KE, Penson DF, Zhao Z, et al. Patient‐reported outcomes through 5 years for active surveillance, surgery, brachytherapy, or external beam radiation with or without androgen deprivation therapy for localized prostate cancer. JAMA. 2020;323(2):149‐163. doi:10.1001/jama.2019.20675.
Schmid FA, Schindele D, Mortezavi A, et al. Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: safety outcomes and complications. Urol Oncol. 2020;38(4):225‐230. doi:10.1016/j.urolonc.2019.09.001.
Stabile A, Orczyk C, Giganti F, et al. The role of percentage of prostate‐specific antigen reduction after focal therapy using high‐intensity focused ultrasound for primary localised prostate cancer. Results from a large multi‐institutional series. Eur Urol. 2020;78(2):155‐160. doi:10.1016/j.eururo.2020.04.068.
Ganzer R, Fritsche HM, Brandtner A, et al. Fourteen‐year oncological and functional outcomes of high‐intensity focused ultrasound in localized prostate cancer. BJU Int. 2013;112(3):322‐329. doi:10.1111/j.1464-410X.2012.11715.x.
Stabile A, Orczyk C, Hosking‐Jervis F, et al. Medium‐term oncological outcomes in a large cohort of men treated with either focal or hemi‐ablation using high‐intensity focused ultrasonography for primary localized prostate cancer. BJU Int. 2019;124(3):431‐440. doi:10.1111/bju.14710.
Ehdaie B, Tempany CM, Holland F, et al. MRI‐guided focused ultrasound focal therapy for patients with intermediate‐risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol. 2022;23(7):910‐918. doi:10.1016/S1470-2045(22)00251-0.
Rompré‐Brodeur A, Marcq G, Tholomier C, et al. Role of systematic control biopsies following partial gland ablation with high‐intensity focused ultrasound for clinically significant prostate cancer. J Urol. 2021;206(5):1177‐1183. doi:10.1097/JU.0000000000001934.
Dickinson L, Ahmed HU, Hindley RG, et al. Prostate‐specific antigen vs. magnetic resonance imaging parameters for assessing oncological outcomes after high intensity‐focused ultrasound focal therapy for localized prostate cancer. Urol Oncol. 2017;35(1):30.e9‐30.e15. doi:10.1016/j.urolonc.2016.07.015.
Ganzer R, Robertson CN, Ward JF, et al. Correlation of prostate‐specific antigen nadir and biochemical failure after high‐intensity focused ultrasound of localized prostate cancer based on the Stuttgart failure criteria‐analysis from the @‐registry. BJU Int. 2011;108(8 Pt 2):E196‐E201. doi:10.1111/j.1464-410X.2011.10091.x.
Ganzer R, Rogenhofer S, Walter B, et al. PSA nadir is a significant predictor of treatment failure after high‐intensity focussed ultrasound (HIFU) treatment of localised prostate cancer. Eur Urol. 2008;53(3):547‐553. doi:10.1016/j.eururo.2007.07.010.
Uchida T, Illing RO, Cathcart PJ, Emberton M. To what extent does the prostate‐specific antigen nadir predict subsequent treatment failure after transrectal high‐intensity focused ultrasound therapy for presumed localized adenocarcinoma of the prostate? BJU Int. 2006;98(3):537‐539. doi:10.1111/j.1464-410X.2006.06297.x.
Ripert T, Azémar MD, Ménard J, et al. Six years' experience with high‐intensity focused ultrasonography for prostate cancer: oncological outcomes using the new “Stuttgart” definition for biochemical failure. BJU Int. 2011;107(12):1899‐1905. doi:10.1111/j.1464-410X.2010.09710.x.
Apfelbeck M, Chaloupka M, Schlenker B, Stief CG, Clevert DA. Follow‐up after focal therapy of the prostate with high intensity focused ultrasound (HIFU) using contrast enhanced ultrasound (CEUS) in combination with MRI image fusion. Clin Hemorheol Microcirc. 2019;73(1):135‐143. doi:10.3233/CH-199222.
Bründl J, Osberghaus V, Zeman F, et al. Oncological long‐term outcome after whole‐gland high‐intensity focused ultrasound for prostate Cancer‐21‐yr follow‐up. Eur Urol Focus. 2021;8:134‐140. doi:10.1016/j.euf.2020.12.016.
فهرسة مساهمة: Keywords: focal therapy; high intensity focused ultrasound therapy; localized prostate cancer; prostate
تواريخ الأحداث: Date Created: 20240306 Date Completed: 20240514 Latest Revision: 20240612
رمز التحديث: 20240612
DOI: 10.1111/eci.14192
PMID: 38445798
قاعدة البيانات: MEDLINE
الوصف
تدمد:1365-2362
DOI:10.1111/eci.14192