Evidência clínica e critérios de seleção para o tratamento focal da próstata com HIFU
Alternativa HIFU à Prostatectomia Radical: Guia Clínico para Urologistas
O Tratamento Não Radical (TNR) com Focal One® é uma alternativa à cirurgia e à radioterapia para doentes com cancro da próstata localizado. Suportado por estudos multicêntricos e validação europeia, o TNR oferece controlo oncológico eficaz, preservando a função urinária e sexual.
Nesta página encontrará:
- Critérios de seleção,
- Orientações para implementação da abordagem na sua prática, e
- Estudos clínicos.
VIA CLÍNICA
Seleção de pacientes
Da elegibilidade clínica à decisão multidisciplinar e ao encaminhamento — o percurso do doente candidato a Tratamento Não Radical com Focal One®.
Critérios de Inclusão
Características do Tumor
- Cancro localizado, sem extensão extracapsular
- Risco favorável a intermédio (Gleason até 3+4)
- Lesão única e delimitada, para ablação zonal
Confirmação por Imagem
- RM multiparamétrica, PI-RADS ≥ 3
- Micro-ecografia (ExactVu®) complementar
- Biópsia de fusão (idealmente)
Fatores do Doente
- Expectativa de vida superior a 10 anos
- Estado geral e comorbilidades
- Preferências e abordagem conservadora
Avaliação Multidisciplinar
Seleção final e plano terapêutico validados em equipa.
Fluxo de Referenciação
PSA
Resultado da biópsia
Relatório da RMm
Resumo clínico
A tecnologia Focal One® está a transformar o tratamento do cancro da próstata.
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Referenciar e tratar com confiança, segundo os standards atuais
Guias e boas práticas
Apresentam-se em seguida recomendações clínicas específicas para a gestão não radical do cancro da próstata, em especial no que se refere ao uso da plataforma Focus One. O objetivo é garantir a uniformização de critérios, a qualidade dos cuidados e a segurança do doente ao longo de todo o percurso terapêutico.
Utilização Clínica da Plataforma Focus One
- Procedimentos de preparação e planeamento do tratamento
- Integração e fusão de imagens para localização precisa da lesão
- Execução do tratamento focal: técnicas, parâmetros e verificação
- Monitorização em tempo real e documentação do procedimento
Seguimento, Complicações e Gestão Clínica
- Protocolos de vigilância após tratamento focal
- Critérios de resposta e identificação de sinais de progressão
- Prevenção e abordagem de complicações funcionais e urológicas
- Abordagens terapêuticas em caso de recidiva localizada
Comunicação, Ética e Desenvolvimento Profissional
- Estruturação da conversa clínica: explicação de opções terapêuticas
- Consentimento informado para terapias não radicais
- Avaliação e discussão sobre qualidade de vida
- Formação contínua: materiais educativos, workshops e bibliografia de referência
Base científica sólida para decisões informadas
Estudos científicos
2024 – European Urology
Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial
G. Ploussard et al.
“This nationwide trial is the first to prospectively comparing HIFU and surgery for the treatment of localized prostate cancer. The results demonstrate that medium-term salvage treatment-free outcomes are comparable with a better safety profile favoring HIFU.”
https://www.europeanurology.com/article/S0302-2838(24)02701-5/abstract
2023 – Minerva Urology and Nephrology
MRI/real-time ultrasound image fusion guided high-intensity focused ultrasound: a prospective comparative and functional analysis of different ablative techniques
S. De Luca, et al.
“Our study suggests that patients’ specific HIFU tailoring with the MRI/real-time TRUS Guidance by Focal One® device is able to minimize the side effects of treatment.”
https://www.minervamedica.it/en/journals/minerva-urology-nephrology/article.php?cod=R19Y2023N02A0172
2021 – Prostate Cancer and Prostatic Diseases
Oncological and functional outcome after partial prostate HIFU ablation with Focal-One : a prospective single-center study
M. Dellabella, et al.
“189 prospectively enrolled prostate cancer patients underwent focal ablation with Focal One Robotic. “Index lesion HIFU ablation demonstrated satisfactory early oncological outcome […]. Urinary function was well preserved.”
2021 – European Urology Focus
Oncological Long-term Outcome After Whole-gland High-intensity Focused Ultrasound for Prostate Cancer—21-yr Follow-up
J. Bründl, et al.
“Long-term data after whole-gland high-intensity focused ultrasound (HIFU) therapy are crucial to prove its oncological efficacy, and may help derive implications for focal treatment strategies and patient selection. In this context, whole-gland HIFU achieved good long-term cancer control up to 21 yr in low- and intermediate-risk prostate cancer (PCa) patients.”
https://www.eu-focus.europeanurology.com/article/S2405-4569(20)30318-7/abstract
2020 – Journal of Urology
High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series
A. Abreu, et al.
“Short-term results of focal high intensity focused ultrasound indicate safety, excellent potency and continence preservation, and adequate short-term prostate cancer control. Radical treatment was avoided in 91% of men at 2 years”
2018 – Journal of EndoUrology
Focal Treatment for Unilateral Prostate Cancer Using High-Intensity Focal Ultrasound: A Comprehensive Study of Pooled Data
S. Albisinni, et al.
“In the 366 analyzed cases, […] at one year after HIFU, negative biopsy rate for clinically significant PCa was 87% (79–96), whereas salvage treatment-free survival rate was 92% (85–98). Regarding functional outcomes, reported potency rates were 74% (64–84), and continence 96% (91–100)…”
2017 – British Journal of Urology International
Salvage high-intensity focused ultrasound (HIFU) for locally recurrent prostate cancer after failed radiation therapy: Multi-institutional analysis of 418 patients
S. Crouzet, et al.
Retrospective study of 418 patients with local recurrent disease after EBRT treated with Salvage HIFU in 9 different centers in Europe. “The OS, CSS and MFS rates at 7 years were 72%, 82% and 81%, respectively.”
https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.13766
2017 – Journal of EndoUrology
Comparing High-Intensity Focal Ultrasound Hemiablation to Robotic Radical Prostatectomy in the Management of Unilateral Prostate Cancer: A Matched-Pair Analysis
S. Albisinni, et al.
“In this matched pair analysis, HIFU hemiablation was comparable to RALP in controlling localized unilateral PCa, with no significant differences in the need for salvage therapies. HIFU was also associated to significantly better functional outcomes.”
2016 – European Urology
Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients
P. Rischmann, et al.
“At 1 yr, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 yr.”
https://www.sciencedirect.com/science/article/abs/pii/S0302283816306790
2015 – Prostate Cancer and Prostatic Diseases
A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer
R. van Velthoven, et al.
“Hemiablation HIFU therapy, delivered with intention to treat, for carefully selected patients affords mid-term promising functional and oncological outcomes.”
2015 – European Urology
Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes
E. Cordeiro, et al.
“This study showed that high-intensity focused ultrasound hemiablation in selected patients with unilateral organ-confined prostate cancer can be used for satisfactory cancer control with minimal effect on genitourinary functions.”
https://www.sciencedirect.com/science/article/abs/pii/S0302283815005217
2014 – British Journal of Urology
Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study
E. Baco, et al.
“Hemi-Salvage HIFU is a feasible therapeutic option in patients with unilateral radiorecurrent prostate cancer, which offers limited urinary and rectal morbidity, and preserves health-related quality of life.”
https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.12545
2013 – Journal of Urology
Evolution and Outcomes of 3 MHz High Intensity Focused Ultrasound Therapy for Localized Prostate Cancer During 15 Years
S. Thüroff, et al.
“Of 704 study patients 78.5% had intermediate or high risk disease. Mean followup was 5.3 years (range 1.3 to 14). Cancer specific survival was 99%, metastasis-free survival was 95%, and 10-year salvage treatment-free rates were 98% in low risk, 72% in intermediate risk and 68% in high risk patients.”
2013 – British Journal of Urology
Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer
R. Ganzer, et al.
“The study demonstrates the efficacy and safety of HIFU for localized PCa. HIFU is a therapeutic option for patients of advanced age, in the low- or intermediate-risk groups, and with a life expectancy of ~10 years.”
Link – n.e.
2013 – European Urology
Whole-gland Ablation of Localized Prostate Cancer with High-intensity Focused Ultrasound: Oncologic Outcomes and Morbidity in 1002 Patients
S. Crouzet, et al.
“HIFU is a potentially effective treatment of localised PCa, with a low PCa-specific mortality rate and a high MFSR at 10 yr as well as acceptable morbidity.”
https://www.sciencedirect.com/science/article/abs/pii/S0302283813004247
Tecnologia robótica de alta precisão
A Plataforma Robótica HIFU de Referência para Urologistas
A tecnologia avançada HIFU (Ultrassons Focalizados de Alta Intensidade) do Focal One® permite definir com precisão as áreas a tratar e atuar de forma dirigida, ao mesmo tempo que protege o tecido saudável, minimizando os efeitos colaterais e mantendo a qualidade de vida.
