Please use this identifier to cite or link to this item:
http://doi.org/10.25358/openscience-9015
Authors: | Duwe, Gregor Boehm, Katharina Haack, Maximilian Sparwasser, Peter Brandt, Maximilian Peter Mager, Rene Tsaur, Igor Haferkamp, Axel Höfner, Thomas |
Title: | Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer : good functional results but oncologically not as safe as expected |
Online publication date: | 24-Apr-2023 |
Year of first publication: | 2023 |
Language: | english |
Abstract: | Purpose Focal therapy (FT) for localized prostate cancer (PCa) is only recommended within the context of clinical trials by international guidelines. We aimed to investigate oncological follow-up and safety data of focal high-intensity focused ultrasound (HIFU) treatment. Methods We conducted a single-center prospective study of 29 patients with PCa treated with (focal) HIFU between 2016 and 2021. Inclusion criteria were unilateral PCa detected by mpMRI-US-fusion prostate biopsy and maximum prostate specific antigen (PSA) of 15 ng/ml. Follow-up included mpMRI-US fusion-re-biopsies 12 and 24 months after HIFU. No re-treatment of HIFU was allowed. The primary endpoint was failure-free survival (FFS), defined as freedom from intervention due to cancer progression. Results Median follow-up of all patients was 23 months, median age was 67 years and median preoperative PSA was 6.8 ng/ml. One year after HIFU treatment PCa was still detected in 13/ 29 patients histologically (44.8%). Two years after HIFU another 7/29 patients (24.1%) were diagnosed with PCa. Until now, PCa recurrence was detected in 11/29 patients (37.93%) which represents an FFS rate of 62%.One patient developed local metastatic disease 2 years after focal HIFU. Adverse events (AE) were low with 70% of patients remaining with sufficient erectile function for intercourse and 97% reporting full maintenance of urinary continence. Conclusion HIFU treatment in carefully selected patients is feasible. However, HIFU was oncologically not as safe as expected because of progression rates of 37.93% and risk of progression towards metastatic disease. Thus, we stopped usage of HIFU in our department. |
DDC: | 610 Medizin 610 Medical sciences |
Institution: | Johannes Gutenberg-Universität Mainz |
Department: | FB 04 Medizin |
Place: | Mainz |
ROR: | https://ror.org/023b0x485 |
DOI: | http://doi.org/10.25358/openscience-9015 |
Version: | Published version |
Publication type: | Zeitschriftenaufsatz |
License: | CC BY |
Information on rights of use: | https://creativecommons.org/licenses/by/4.0/ |
Journal: | World journal of urology Version of Record (VoR) |
Publisher: | Springer |
Publisher place: | Berlin u.a. |
Issue date: | 2023 |
ISSN: | 1433-8726 |
Publisher DOI: | 10.1007/s00345-023-04352-9 |
Appears in collections: | DFG-491381577-H |
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File | Description | Size | Format | ||
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![]() | singlecenter_prospective_phas-20230417152619876.pdf | 614.81 kB | Adobe PDF | View/Open |