Original Title: Ultrasonidos focalizados de alta intensidad (HIFU) en tumores prostáticos órgano-confinados. Actualización

Authors' objectives: To evaluate the effectiveness and safety of focal prostate ablation with high intensity focused ultrasound (HIFU) in patients with low and intermediate risk organ-confined prostate cancer.

Authors' results and conclusions: Results Three documents were included, a health technology assessment report carried out by the NHS (National Institute for Health Research), a randomized clinical feasibility trial and a retrospective comparative study. Some weaknesses were identified in the quality analysis and the overall quality was moderate. In the assessment report, the effectiveness measured in terms of oncologic outcomes did not have significant differences between HIFU and radical prostatectomy or active surveillance. Radiotherapy was associated with less biochemical recurrence in one-year follow-up, but this difference disappeared at 5 years follow-up. In the retrospective study, both biochemical recurrence and biochemical recurrence-free survival at three years were significantly better in the HIFU treatment group (24.2 % and 27.66 months, respectively) than in the other therapies (radical prostatectomy: 54.7 % and 22.13 months; brachytherapy: 31.6 % and 21.17 months; and cryotherapy: 31.6 % and 26.39 months; p = 0.000 in all cases). In the RCT, significant differences were published at 12 months in favor of HIFU versus radical prostatectomy inurinary incontinence (differences in EPIC: 10.8 with 95 % CI from 4.1 to 17.5) and sexual function (differences in EPIC: 12.5 with 95 % CI from 4.5 to 18.5). Regarding adverse effects, HIFU may be associated with a higher rate of urethral stricture than radiotherapy, but radical prostatectomy shows 30 % of urethral stricture and 11 % of urinary incontinence versus 10.8 % stricture and 2.5 % incontinence in HIFU. Conclusions No functional problems or serious adverse effects have been found associated with the use of HIFU. Nonetheless, given the heterogeneity of the included studies and their methodological limitations, the evidence analyzed does not allow to conclude the equivalence between HIFU and RP. New evidence is needed based on prospective, controlled, randomized studies that establish direct comparisons with other treatments and that provide long-term efficacy and safety results.

Authors' methods: Systematic literature review, including technology assessment reports, systematic reviews, randomized controlled trials and observational studies. The following reference databases were consulted until March 2021 (with free and controlled language): Medline, EMBASE, Web of Science and Cochrane Library. INAHTA, the CRD database, NICE and the CADTH website were also explored. The selection of the studies and the analysis of their quality were carried out by two independent reviewers. The synthesis of the results was carried out qualitatively. The quality of the studies was assessed using the AMSTAR-2 tool for systematic reviews, the Cochrane Tool for RCT and Critical Appraisal Tools by OSTEBA for observational studies.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/ultrasonidos-focalizados-de-alta-intensidad-hifu-en-tumores-prostaticos-organo-confinados/

Year Published: 2021

URL for published report: https://www.aetsa.org/download/AETSA_HIFU_TUMORES-PROSTATICOS_ACTUALIZACION_DEF_NIPOenTRAMITE_DOI.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

DOI: https://doi.org/10.52766/SAGJ1958

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)