High-intensity focused ultrasound with visually directed power adjustment for focal treatment of localized prostate cancer: systematic review and meta-analysis.

PURPOSE: To characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer. METHODS: We performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model. RESULTS: A total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9-3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4-28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7-23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1-11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9-24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0-19.0%) for urinary retention, 3.0% (95% CI 2.1-3.9%) for urinary tract infection, 1.9% (95% CI 0.1-5.3%) for urinary incontinence, and 0.1% (95% CI 0.0-1.4%) for bowel injury. CONCLUSION: Limited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking.

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

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.

Focal therapy with high-intensity focused ultrasound for prostate cancer: 3-year outcomes from a prospective trial.

OBJECTIVE: To assess the oncological and functional outcomes of focal high-intensity focused ultrasound (HIFU) in treating localised prostate cancer (PCa), a 3-year prospective study was undertaken using periodic post-ablation saturation biopsies. PATIENTS AND METHODS: Men with two or fewer lesions of grade group (GG) ≤3 PCa were eligible for participation. Additional criteria included a prostate-specific antigen (PSA) level of ≤15 ng/mL, clinical T1c-T2, and a life expectancy of ≥10 years. The primary endpoint was failure-free survival (FFS), defined as absence of clinically significant PCa (csPCa) in- or out-of-field on protocol-mandated saturation biopsy, no whole-gland or systemic salvage treatment, PCa metastasis, or PCa-related death. Results are reported using two distinct definitions of csPCa: (i) the presence of any GG ≥2 and (ii) any GG ≥3 or core involvement of ≥6 mm. Secondary endpoints were functional patient-reported outcome measures addressing urinary, sexual, and bowel function. RESULTS: A total of 91 patients were included: six (7%) with GG1 and 85 (93%) with GG ≥2. In all, 83 (91%) underwent at least one follow-up biopsy. Biopsy attendance at 6, 12, and 36 months was 84%, 67%, and 51%, respectively. The FFS at these time points for any GG ≥2 PCa was 79% (95% confidence interval [CI] 80-88%), 57% (95% CI 48-69%) and 44% (95% CI 34-56%), respectively. Using the second definition, FFS were 88% (95% CI 81-95%), 70% (95% CI 61-81%) and 65% (95% CI 55-77%), respectively. The 3-year cancer-specific survival was 100%, and freedom from metastasis was 99%. Magnetic resonance imaging (MRI) (negative predictive value of up to 89%, 95% CI 84-93%) and relative decrease of PSA values (P = 0.4) performed poorly in detecting residual disease. Urinary and bowel assessment returned to baseline questionnaire scores within 3 months. In all, 17 (21%) patients reported meaningful worsening in erectile function. A significant decrease of PCa related anxiety was observed. CONCLUSIONS: Focal HIFU treatment for localised PCa shows excellent functional outcomes with half of the patients remaining cancer-free after 3 years. Whole-gland treatment was avoided in 81%. Early follow-up biopsies are crucial to change or continue the treatment modality at the right time, while the use of MRI and PSA in detecting PCa recurrence is uncertain.

[Oncological and functional results of focal treatment of localized prostate cancer with HIFU]. / Résultats oncologiques et fonctionnels du traitement focal du cancer de prostate localisé par HIFU.

INTRODUCTION: In recent years, improved diagnosis of prostate cancer has allowed the development of focal therapy, in order to reduce the morbidity of treatments. Our study assesses the medium-term oncological and functional results of FocalOne® HIFU treatment in localized prostate cancer. METHODS: This is a retrospective, multicentre study including patients with low- or intermediate-risk localized prostate cancer treated with Focal one HIFU between November 2014 and December 2019. The primary endpoint was the retreatment rate and subgroup analyses were performed to identify predictive factors of retreatment. RESULTS: One hundred and thirty-seven patients were included with a median follow-up of 25.5 months. Seventy percent of patients had clinical stage T2, 64% had an ISUP score of 2 or 3 on initial biopsies and 38% were treated with hemi-ablation. Follow-up biopsies were performed in 76.6% of patients during follow-up with 21.8% having clinically significant cancers. The retreatment rate at 24 months was 37.2%, with positive biopsies being the primary criterion for retreatment. Patients with a PSA>8ng/mL had a significantly higher retreatment rate. Finally, morbidity remained acceptable with 5.8% of patients requiring reoperation for complications and 21% for de novo erectile dysfunction. CONCLUSION: Our results are in agreement with those of the literature, seeming to indicate a lower morbidity of the focal treatment by HIFU compared to the radical treatments while offering an acceptable oncological control. Prospective randomized trials are ongoing.

ASO Author Reflections: High-Intensity Focused Ultrasound will Become the Routine Practice for Treatment of Localized Prostate Cancer.

PAST: Most prostate cancers are slow growing and are often diagnosed at an old age, which may result in treatment never being needed. However, definitive treatments such as radical prostatectomy and radiation therapy are often associated with many serious adverse effects, harming the physical and mental health of patients. PRESENT: In recent years, different types of minimally invasive therapy have been developed to achieve cancer control, continence, and even potency preservation, such as high-intensity focused ultrasound (HIFU). HIFU has been proposed for prostate cancer patients to provide an equivalent oncologic result to definitive treatment, with a reduced adverse effect profile, thus increasing the interest in HIFU for the treatment of localized prostate cancer. FUTURE: Sonablate® HIFU performed an outstanding cancer control in treating localized prostate cancer, with low biochemical recurrence and complication rates. As further long-term follow-up data mature, we anticipate the routine application of HIFU for localized prostate cancer within the next few years.

High-Intensity Focused Ultrasound (Sonablate®) for Prostate Cancer: Preliminary Outcomes in Taiwan.

PURPOSE: We reported preliminary outcomes of high-intensity focused ultrasound (HIFU) [Sonablate®] in the combination of transurethral resection of the prostate for localized prostate cancer in Taiwan. METHODS: Seventy-seven patients using Sonablate® HIFU for localized prostate cancer were enrolled in this study from April 2021 to December 2022. Prostate-specific antigen biochemical recurrence, International Index of Erectile Function (IIEF)-5 scores, International Prostate Symptom Score (IPSS), quality of life (QoL) scores, and postoperative complications were recorded during follow-up. RESULTS: Overall, 19.5% of patients were low-risk, 36.4% were intermediate-risk, and 44.1% were high-risk according to the D'Amico risk classification. The median follow-up was 12.09 ± 5.85 months, and the biochemical-free survival rates for the low-, intermediate-, and high-risk groups were 100% (15/15), 96.4% (27/28), and 79.4% (27/34), respectively. Four patients (5.2%) received salvage radiotherapy and all maintained biochemical-free survival. The mean IPSS and QoL scores before versus after HIFU were 10.4 versus 6.8 (p = 0.003) and 3.2 versus 3.0 (p = 0.096), respectively. There was no statistically significant change in preoperative and postoperative IIEF scores (20.6 vs. 19; p = 0.062) in patients who had an IIEF score of >15 at baseline and received nerve-sparing procedures (subtotal ablation). CONCLUSIONS: The results of Sonablate® HIFU in Taiwan indicated adequate short-term cancer control, excellent potency, and continence preservation. HIFU can achieve improvement of IPSS with low complication rates.

External validation of biochemical recurrence definition to predict oncologic outcomes following focal therapy for localized prostate cancer using high intensity focused ultrasound.

PURPOSE: This is an external validation of several biochemical recurrence definitions based on prostate specific antigen criteria (PSA). The purpose is to predict the need of additional treatment and failure after focal therapy using high intensity focused ultrasound (HIFU) for localized prostate cancer (PCa). MATERIALS AND METHODS: A total of 343 consecutive patients who underwent HIFU with Ablatherm® and Focal One® devices between June 2001 and November 2020 were identified. Treatment failure was defined as clinically significant PCa on postoperative biopsy, the need for salvage radical or systematic treatment, metastasis, or PCa-related death. The biochemical recurrence definitions tested were PSA nadir, time to PSA nadir, percentage of PSA reduction, Huber et al. criteria defined as PSA nadir + 1 ng/mL at 12 months or PSA nadir + 1.5 ng/mL at 24-36 months. Multivariable Cox regression analysis and decision-curve analysis were used to validate and compare criteria. Kaplan-Meier analysis was used to assess criteria associated with the highest accuracy. RESULTS: One hundred seventy-eight patients met the inclusion criteria and were analyzed. Overall, 61 (34%) and 41 (23%) patients had an additional treatment and failure with a median follow-up of 52 months. At multivariable analysis, model including Huber et al. criteria exhibited the highest Harrell's C-index for the prediction of the need of additional treatment (hazard ratio [HR]: 10, p < 0.001, c-index: 84%) and treatment failure (HR: 9.1, p < 0.001, c-index: 82%) as well as higher net benefit. The 60-months need of additional treatment and treatment failure-free survival were 89% and 98% compared to 26% and 49%, respectively, when stratified according to Huber et al. criteria (Log-rank test, p < 0.001). Similar results were found after excluding patient with non-clinically significant PCa at initial biopsy. CONCLUSIONS: We report an external validation of biochemical recurrence definitions predicting the need of additional treatment and failure after focal therapy using HIFU for localized PCa. Huber et al. criteria were identified as the most accurate and could be used to guide clinicians toward further evaluation and salvage treatments.

Sección del ligamento transverso del carpo de forma percutánea ecoguiada vs. cirugía abierta para el tratamiento quirúrgico del síndrome del túnel del carpo (STC) / Percutaneous ultrasound-guided section of the transverse carpal ligament vs open surgery for the surgical treatment of carpal tunnel syndrome (CTS)

Antecedentes y objetivo: El gold standard del tratamiento del síndrome del túnel carpiano (STC) es la sección del ligamento transverso del carpo, siendo la técnica más común la incisión cutánea palmar. Se han desarrollados técnicas percutáneas, aunque su relación riesgo/beneficio sigue siendo controvertida. Objetivo: Analizar el resultado funcional de los pacientes intervenidos de STC de forma percutánea ecoguiada y compararlo con cirugía abierta. Material y método: Estudio de cohortes observacional prospectivo de 50 pacientes intervenidos de STC (25 percutáneos con técnica Walant y 25 por cirugía abierta con anestesia local y manguito de isquemia). La cirugía abierta se realizó mediante una incisión palmar corta. La técnica percutánea se realizó de forma anterógrada utilizando el bisturí Kemis® H3 (Newclip). Se realizó una valoración preoperatoria y postoperatoria a las dos semanas, seis semanas y tres meses. Se recogieron datos demográficos, presencia de complicaciones, fuerza de prensión y puntuación del test de Levine (BCTQ). Resultados: La muestra consta de 14 hombres y 36 mujeres con edad media de 51,4 años (IC 95%: 48,4-54,5). Todos los pacientes mejoraron de su clínica de STC sin obtener diferencias estadísticamente significativas en la puntuación BCTQ, ni en la presencia de complicaciones (p > 0,05). Los pacientes intervenidos de forma percutánea recuperaron más rápida la fuerza de prensión a las seis semanas, pero fue similar en la revisión final. Conclusiones: En vista de los resultados obtenidos, la cirugía percutánea ecoguiada es una buena alternativa para el tratamiento quirúrgico del STC. Esta técnica requiere su curva de aprendizaje y familiarización con la visualización ecográfica de las estructuras anatómicas a tratar.(AU)

Background and objective: The gold standard of carpal tunnel syndrome (CTS) treatment is the section of the transverse carpal ligament, the most common technique being the palmar cutaneous incision. Percutaneous techniques have been developed, although their risk/benefit ratio remains controversial. Objective: To analyze the functional outcome of patients undergoing CTS percutaneously ultrasound-guided and compare it with those of open surgery. Material and method: Prospective observational cohort study of 50 patients undergoing CTS (25 percutaneous with WALANT technique and 25 by open surgery with local anesthesia and tourniquet). Open surgery was performed using a short palmar incision. The percutaneous technique was performed anterograde using the Kemis® H3 scalpel (Newclip). A preoperative and postoperative assessment was performed at 2 weeks, 6 weeks and 3 months. Demographic data, presence of complications, grip strength and Levine test score (BCTQ) were collected. Results: The sample consists of 14 men and 36 women with a mean age of 51.4 years (95% CI: 48.4-54.5). Percutaneous technique was performed anterograde using the Kemis® H3 scalpel (Newclip). All patients improved from their CTS clinic without obtaining statistically significant differences in BCTQ score, nor in the presence of complications (p> 0.05). Patients operated on percutaneously recovered faster grip strength at 6 weeks, but it was similar in the final review. Conclusions: In view of the results obtained, percutaneous ultrasound-guided surgery is a good alternative for the surgical treatment of CTS. Logically, this technique requires its learning curve and familiarization with the ultrasound visualization of the anatomical structures to be treated.(AU)

[Translated article] Percutaneous ultrasound-guided section of the transverse carpal ligament vs. open surgery for the surgical treatment of carpal tunnel syndrome (CTS) / Sección del ligamento transverso del carpo de forma percutánea ecoguiada vs. cirugía abierta para el tratamiento quirúrgico del síndrome del túnel del carpo (STC)

Antecedentes y objetivo: El gold standard del tratamiento del síndrome del túnel carpiano (STC) es la sección del ligamento transverso del carpo, siendo la técnica más común la incisión cutánea palmar. Se han desarrollados técnicas percutáneas, aunque su relación riesgo/beneficio sigue siendo controvertida. Objetivo: Analizar el resultado funcional de los pacientes intervenidos de STC de forma percutánea ecoguiada y compararlo con cirugía abierta. Material y método: Estudio de cohortes observacional prospectivo de 50 pacientes intervenidos de STC (25 percutáneos con técnica Walant y 25 por cirugía abierta con anestesia local y manguito de isquemia). La cirugía abierta se realizó mediante una incisión palmar corta. La técnica percutánea se realizó de forma anterógrada utilizando el bisturí Kemis® H3 (Newclip). Se realizó una valoración preoperatoria y postoperatoria a las dos semanas, seis semanas y tres meses. Se recogieron datos demográficos, presencia de complicaciones, fuerza de prensión y puntuación del test de Levine (BCTQ). Resultados: La muestra consta de 14 hombres y 36 mujeres con edad media de 51,4 años (IC 95%: 48,4-54,5). Todos los pacientes mejoraron de su clínica de STC sin obtener diferencias estadísticamente significativas en la puntuación BCTQ, ni en la presencia de complicaciones (p > 0,05). Los pacientes intervenidos de forma percutánea recuperaron más rápida la fuerza de prensión a las seis semanas, pero fue similar en la revisión final. Conclusiones: En vista de los resultados obtenidos, la cirugía percutánea ecoguiada es una buena alternativa para el tratamiento quirúrgico del STC. Esta técnica requiere su curva de aprendizaje y familiarización con la visualización ecográfica de las estructuras anatómicas a tratar.(AU)

Background and objective: The gold standard of carpal tunnel syndrome (CTS) treatment is the section of the transverse carpal ligament, the most common technique being the palmar cutaneous incision. Percutaneous techniques have been developed, although their risk/benefit ratio remains controversial. Objective: To analyze the functional outcome of patients undergoing CTS percutaneously ultrasound-guided and compare it with those of open surgery. Material and method: Prospective observational cohort study of 50 patients undergoing CTS (25 percutaneous with WALANT technique and 25 by open surgery with local anesthesia and tourniquet). Open surgery was performed using a short palmar incision. The percutaneous technique was performed anterograde using the Kemis® H3 scalpel (Newclip). A preoperative and postoperative assessment was performed at 2 weeks, 6 weeks and 3 months. Demographic data, presence of complications, grip strength and Levine test score (BCTQ) were collected. Results: The sample consists of 14 men and 36 women with a mean age of 51.4 years (95% CI: 48.4-54.5). Percutaneous technique was performed anterograde using the Kemis® H3 scalpel (Newclip). All patients improved from their CTS clinic without obtaining statistically significant differences in BCTQ score, nor in the presence of complications (p> 0.05). Patients operated on percutaneously recovered faster grip strength at 6 weeks, but it was similar in the final review. Conclusions: In view of the results obtained, percutaneous ultrasound-guided surgery is a good alternative for the surgical treatment of CTS. Logically, this technique requires its learning curve and familiarization with the ultrasound visualization of the anatomical structures to be treated.(AU)

[HIFU therapy of localized prostate cancer using image-guided robotic HIFU Focal One].

INTRODUCTION: Prostate cancer (PCa) is the second most commonly diagnosed malignant tumor in men after lung cancer and is the fifth leading cause of death worldwide. In November 2019, the spectrum of alternative treatment for PCa was added by a novel minimally invasive method, namely high-intensity focused ultrasound (HIFU) using the latest Focal One machine (with the possibility of combining intraoperative ultrasound and preoperative MRI data). MATERIALS AND METHODS: During the period from November 2019 to November 2021, HIFU using Focal One device (manufactured by EDAP, France) was performed in 75 patients with PCa. Total ablation was done in 45 cases, while 30 patients undergone to focal prostate ablation. The average age of the patients was 62.7 (51-80) years, the total PSA level was 9.3 (3.2-15.5) ng/ml and the prostate volume was 32.0 (11-35) cc. The maximum urinary rate was 13.3 (6.3-36) ml/s, IPSS score was 7 (3-25) points, IIEF-5 score was 18 (4-25). Clinical stage c1N0M0 was diagnosed in 60 patients, 1bN0M0 in 4 patients, 2N0M0 in 11 patients. In 21 cases, transurethral resection of the prostate was performed within 4-6 weeks prior to total ablation. Before surgery, all patients underwent magnetic resonance imaging (MRI) of the pelvis with intravenous contrast and PIRADS V2 assessment. MRI data were used intraoperatively for precision planning of the procedure. RESULTS: In all patients, the procedure was performed under endotracheal anesthesia in accordance with the technical recommendations of the manufacturer. Prior to surgery, a silicone urethral catheter of 16 or 18 Ch was placed. The average duration of the intervention was 101 (56-147) minutes. The postoperative period was uneventful in all cases.Patients received antibiotic therapy via parenteral route for 4 days, followed by oral administration for another 10 days, as well as alpha-blockers (at least 1 month after procedure). After removal of urethral catheter on the 4th day, all patients started to void. In 9 cases there was acute urinary retention in the evening and in 4 patients in the next morning, requiring temporary bladder catheterization. A year after the procedure, 53 patients were fully examined: the average total PSA level in patients who underwent total ablation (n=53) was 0.96+/-0.11 ng/ml, the IPSS score was 6.9+/-0,6 points (no difference compared to baseline). Follow-up biopsy revealed PCa in 6 patients; in other cases, prostate fibrosis was determined. CONCLUSIONS: HIFU in patients with localized PCa using image-guided robotic HIFU (Focal One) is promising and feasible. This method has shown good oncological results with a short follow-up period. It is advisable to carry out further prospective analysis.

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.

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.

Direct costs of treating men with prostate cancer with High Intensity Focused Ultrasound / Costos directos del tratamiento de hombres con cáncer de próstata con el uso de High Intensity Focused Ultrasound / Custos diretos do tratamento de homens com câncer de próstata via High Intensity Focused Ultrasound

ABSTRACT Objective: To analyze the direct costs of materials, medicines/solutions and healthcare professionals required to treat men with prostate cancer using High Intensity Focused Ultrasound. Method: Quantitative, exploratory-descriptive research, single case study type. Data were collected from electronic medical records/printed documentation from the Operating Room of a public teaching and research hospital. Health professionals estimated the respective time spent on activities in the following stages: "Before anesthetic induction", "Before performing thermal ablation", "During thermal ablation" and "After performing thermal ablation". Costs were calculated by multiplying the (estimated) time spent by the unit cost of direct labor, adding to the measured cost of materials, medicines/solutions. Results: The measured costs with materials corresponded to US$851.58 (SD = 2.17), with medicines/solutions to US$72.13 (SD = 25.84), and estimated personnel costs to US$196.03, totaling US$1119.74/procedure. Conclusion: The economic results obtained may support hospital managers in the decision-making process regarding the adoption of the High Intensity Focused Ultrasound for the treatment of prostate cancer.

RESUMEN Objetivo: Analizar los costos directos de materiales, medicamentos/soluciones y profesionales de la salud necesarios para tratar a hombres con cáncer de próstata a través de High Intensity Focused Ultrasound. Método: Investigación cuantitativa, exploratoria-descriptiva, tipo estudio de caso único. Los datos se obtuvieron de registros médicos electrónicos/documentación impresa del Centro Quirúrgico de un hospital público de enseñanza e investigación. Los profesionales de la salud estimaron el tiempo respectivo dedicado a las actividades en las siguientes etapas: "Antes de la inducción anestésica", "Antes de realizar la ablación térmica", "Durante la realización de la ablación térmica" y "Después de realizar la ablación térmica". Los costos se calcularon multiplicando el tiempo (estimado) invertido por el costo unitario de la mano de obra directa, sumándolo al costo medido de materiales, medicamentos/soluciones. Resultados: Los costos medidos con materiales correspondieron a US$851,58 (DE = 2,17), con medicamentos/soluciones a US$72,13 (DE = 25,84) y los costos de personal estimados a US$196,03, totalizando US$1119,74/procedimiento. Conclusión: Los resultados económicos obtenidos podrán apoyar a los gestores hospitalarios en el proceso de toma de decisiones respecto a la adopción del High Intensity Focused Ultrasound para el tratamiento del cáncer de próstata.

RESUMO Objetivo: Analisar os custos diretos com materiais, medicamentos/soluções e profissionais de saúde requeridos à realização do tratamento de homens com câncer de próstata via High Intensity Focused Ultrasound. Método: Pesquisa quantitativa, exploratória-descritiva, do tipo estudo de caso único. Coletaram-se os dados em prontuários eletrônicos/documentações impressas do Centro Cirúrgico de um hospital público de ensino e pesquisa. Profissionais de saúde estimaram os respectivos tempos despendidos em atividades constantes das etapas: "Antes da indução anestésica", "Antes da execução da termoablação", "Durante a execução da termoablação" e "Após a execução da termoablação". Calcularam-se os custos multiplicando-se o tempo (estimado) despendido pelo custo unitário da mão de obra direta, somando-se ao custo mensurado dos materiais, medicamentos/soluções. Resultados: Os custos mensurados com materiais corresponderam a US$851,58 (DP = 2,17), com medicamentos/soluções a US$72,13 (DP = 25,84) e os custos estimados com pessoal a US$196,03, totalizando US$1119,74/procedimento. Conclusão: Os resultados econômicos obtidos poderão subsidiar os gestores hospitalares no processo decisório quanto à adoção do High Intensity Focused Ultrasound para o tratamento do câncer de próstata.

Impacto de los factores de riesgo en la eficacia y complicaciones de la biopsia hepática percutánea ecoguiada de lesiones ocupantes de espacio / Impact of risk factors on the efficacy and complications of ultrasound-guided percutaneous liver biopsy of space-occupying lesions

Introducción: La biopsia hepática percutánea ecoguiada se considera la técnica de elección para el diagnóstico histológico de las lesiones ocupantes de espacio (LOE), dada su elevada seguridad y rentabilidad diagnóstica. Sin embargo, al tratarse de una técnica de diagnóstico invasiva, no se encuentra exenta de complicaciones. Diversos parámetros clínico-radiológicos han sido analizados como factores relacionados con la eficacia o complicaciones, con resultados contradictorios. Por todo ello, el objetivo de nuestro estudio es evaluar el impacto de diversos factores de riesgo en la eficacia y complicaciones de la biopsia hepática percutánea ecoguiada en el diagnóstico de LOE, en el ámbito de la práctica clínica habitual. Material y métodos: Llevamos a cabo un estudio observacional, retrospectivo, unicéntrico de pacientes sometidos a biopsia hepática percutánea ecoguiada en tiempo real con técnica de manos libres para el diagnóstico de LOE, realizadas en el Servicio de Radiodiagnóstico del Hospital Clínico Universitario de Santiago de Compostela entre diciembre 2012 y febrero 2018. Seleccionamos como factores de riesgo: la localización de la LOE en los segmentos hepáticos superiores (II, IVa, VII y VIII), la proximidad a la cápsula hepática, la distancia entre piel y LOE mayor de 100mm, la interposición de estructuras óseas o vasculares, la incapacidad para atravesar parénquima sano o la falta de colaboración del paciente durante el procedimiento. La eficacia fue analizada en términos de número de cilindros extraídos y porcentaje de biopsias satisfactorias; y la seguridad, en términos de porcentaje de complicaciones presentadas, clasificándolas, a su vez, en complicaciones mayores y menores. Resultados: Se incluyeron 295 biopsias de 278 pacientes. La mediana de edad fue de 69 años, el 64,1% eran varones y el 44,7% tenía una neoplasia previa.(AU)

Introduction: Ultrasound-guided percutaneous liver biopsy is considered the technique of choice for the histological diagnosis of space-occupying lesions, given its high level of safety and diagnostic performance. However, since it is an invasive diagnostic procedure, complications can occur. Various clinical and radiological parameters have been analyzed as factors related with the efficacy of the technique or with its complications; however, the results have been contradictory. Thus, we aimed to evaluate the impact of various risk factors on the efficacy and complications of ultrasound-guided percutaneous liver biopsy in the diagnosis of space-occupying lesions in ordinary clinical practice. Material and methods: This retrospective observational study included all patients who underwent real-time ultrasound-guided percutaneous biopsies of space-occupying liver lesions with the free-hand technique between December 2012 and February 2018 in the diagnostic imaging department at the Hospital Clínico Universitario de Santiago de Compostela. We analyzed the following risk factors: location of the lesion in upper liver segments (II, IVa, VII, or VIII); proximity to the liver capsule, distance from the skin > 100mm, interposition of osseus or vascular structures, inability to go through healthy parenchyma, and lack of patient cooperation during the procedure. Efficacy was analyzed in terms of the number of cylinders obtained and the percentage of adequate biopsies; safety was analyzed in terms of the percentage of complications, which were classified as major or minor. Results: We included 295 biopsies in 278 patients (median age, 69 years; 64.1% male; 44.7% had prior neoplasms). In 61.4%, the biopsy was indicated for the initial diagnosis; 82.4% of biopsies were done in hospitalized patients, and 65% of the lesions were located in the right liver lobe.(AU)

Diagnóstico ecográfico de la neoplasia prostática y su relación histológica / Ultrasound diagnosis of prostatic neoplasia and histological relationship

Introducción: El desarrollo de la tecnología con el ultrasonido transrectal ha permitido obtener imágenes diagnósticas de la glándula prostática; su interés deriva de la inmensa frecuencia de problemas clínicos, tanto benignos como malignos. El medio diagnóstico del cáncer de próstata se basa en una biopsia dirigida por ultrasonido transrectal en la mayoría de los casos. Objetivo: Determinar los hallazgos ultrasonográficos y su relación con estudios histopatológico en el diagnóstico de la neoplasia prostática, de los pacientes con sospecha, atendidos en la consulta de urooncología. Métodos: Se realizó un estudio descriptivo transversal en pacientes con sospecha clínica de cáncer prostático, procedentes del servicio de urología en el Hospital Celia Sánchez Manduley en el período comprendido entre julio de 2019 a julio de 2021; que acudieron a consulta con indicación de ultrasonido transrectal. El universo estuvo constituido por 105 pacientes. Se utilizaron criterios de inclusión y exclusión para la selección del universo, previo consentimiento informado de los pacientes. Las variables estudiadas fueron: edad, color de la piel, síntomas clínicos, hallazgos del ultrasonido transrectal, relación ecosonográfica- anatomopatológico. Resultados: Predominó el grupo de edad de 60 a 79 años, de la raza negra, con síntomas urinarios obstructivos bajos, con presencia del nódulo hipoecoico. Predominó la localización ultrasonográfica periférica, así como el adenocarcinoma prostático como hallazgos anatomopatológico encontrado a través de la biopsia. Conclusiones: Se demostró correlación ecográfica-histológica y anatomopatológica(AU)

Introduction: The development of transrectal ultrasound technology has made it possible to obtain diagnostic images of the prostate gland; its interest derives from the massive frequency of clinical problems, both benign and malignant. The diagnosis of prostate cancer is based on a transrectal ultrasound-guided biopsy in most cases. Objective: To determine the ultrasonographic findings and the how they relate with histopathological studies in the diagnosis of prostatic neoplasia in suspected patients treated in the uro-oncology clinic. Methods: A cross-sectional descriptive study was carried out in patients with clinical suspicion of prostate cancer, in the urology service at Celia Sánchez Manduley Hospital from July 2019 to July 2021; they attended the consultation with an indication for transrectal ultrasound. The universe consisted of 105 patients. Inclusion and exclusion criteria were used for the selection of the universe, with the prior informed consent of the patients. The variables studied were age, skin color, clinical symptoms, transrectal ultrasound findings, echosonographic-pathological relationship. Results: Predominance was observed of subjects from the age group of 60 to 79 years, black race, with lower obstructive urinary symptoms, and presence of hypoechoic nodule. Peripheral ultrasonographic location prevailed, as well as prostatic adenocarcinoma as pathological findings found through biopsy. Conclusions: Ultrasound-histological and pathological correlation was demonstrated(AU)

Outcomes of partial gland ablation using high intensity focused ultrasound for prostate cancer.

BACKGROUND: To evaluate the clinical and oncological outcomes of partial gland ablation (PGA) using high intensity focused ultrasound (HIFU) technique for the clinically unilateral prostate cancer. METHODS: We performed a retrospective analysis for the 163 patients who treated by PGA for clinically unilateral prostate cancer. The PGA was performed using Focal one system with concurrent trans-urethral prostatectomy. The oncological and functional outcomes were evaluated as well as risk factors for remnant disease after PGA. Clinically significant cancer was defined as grade group ≥2. RESULTS: Among the entire subjects, grade group 2 or greater was present at pre-treatment biopsy in 76.7%. Median follow-up time was 17 months and 60.1% of total subjects had follow-up biopsy at postoperative 1 year. There were 25 subjects (24.2%) with any cancer and 13 subjects (12.6%) with CS cancer at the follow-up biopsy. The preoperative age and number of positive cores at preoperative biopsy were significantly associated with positive results at follow-up biopsy. Incontinence which requires 2 or more pads per day was observed at 4 subjects (2.5%) postoperatively. There were no subjects who needed intensive care or experienced rectal complications. CONCLUSION: The PGA with HIFU was safe and showed good preservation of functional outcomes as well as satisfactory oncological control. The remnant disease was observed in the 24.5% of patients who underwent follow-up biopsy in the present study. Thus, further prospective study is needed to evaluate oncological and functional outcomes of PGA with HIFU more accurately.

Long-term outcomes of whole gland high-intensity focused ultrasound for localized prostate cancer.

OBJECTIVES: To report the 10-year oncologic and functional outcomes of whole-gland HIFU as first-line treatment for localized prostate cancer (PCa). PATIENTS AND METHODS: Patients were retrospectively included between January 2005 and July 2018 from a prospectively maintained database at a single academic institution. No patient underwent androgen deprivation therapy prior to HIFU. Primary endpoint was biochemical recurrence-free survival (BRFS). Secondary oncological endpoints included salvage treatment-free survival (STFS), cancer-specific survival (CSS) and overall survival (OS). RESULTS: A total of 97 patients met our inclusion criteria and were included in the final analysis. According to D'Amico classification, the numbers of patients with low-, intermediate-, and high-risk disease were 38 (39.2%), 52 (53.6%), and 7 (7.2%). A total of 21 (21.6%) patients received salvage treatment at a mean of 4.1 years (± 2.8) after HIFU. The 10-year OS, CSS and BRFS rates were 91.8%, 100% and 40.3% in the overall cohort, respectively. In multivariate analysis, predictive factors for biochemical recurrence were intermediate-risk group (RR = 2.065; 95% CI 1.008-4.230; p = 0.047) and PSA nadir > 0.5 ng/mL (RR = 4.963; 95% CI 2.251-10.947; p < 0.001). Symptoms related to bladder outlet obstruction were the most frequently recorded adverse events. In multivariate analysis, positive biopsy on the prostatic apex was predictor of obstructive complications (RR = 3.2, 95% CI 1.092-9.476, p = 0.034). Only four patients developed severe urinary incontinence (> 1 pad/day). CONCLUSIONS: HIFU showed low PCa-specific mortality, but biochemical recurrence rates were highly variable among patients. Future studies are needed to improve patient selection.

Available evidence on HIFU for focal treatment of prostate cancer: a systematic review

ABSTRACT Purpose: Prostate cancer (PCa) is the second most common oncologic disease among men. Radical treatment with curative intent provides good oncological results for PCa survivors, although definitive therapy is associated with significant number of serious side-effects. In modern-era of medicine tissue-sparing techniques, such as focal HIFU, have been proposed for PCa patients in order to provide cancer control equivalent to the standard-of-care procedures while reducing morbidities and complications. The aim of this systematic review was to summarise the available evidence about focal HIFU therapy as a primary treatment for localized PCa. Material and methods: We conducted a comprehensive literature review of focal HIFU therapy in the MEDLINE database (PROSPERO: CRD42021235581). Articles published in the English language between 2010 and 2020 with more than 50 patients were included. Results: Clinically significant in-field recurrence and out-of-field progression were detected to 22% and 29% PCa patients, respectively. Higher ISUP grade group, more positive cores at biopsy and bilateral disease were identified as the main risk factors for disease recurrence. The most common strategy for recurrence management was definitive therapy. Six months after focal HIFU therapy 98% of patients were totally continent and 80% of patients retained sufficient erections for sexual intercourse. The majority of complications presented in the early postoperative period and were classified as low-grade. Conclusions: This review highlights that focal HIFU therapy appears to be a safe procedure, while short-term cancer control rate is encouraging. Though, second-line treatment or active surveillance seems to be necessary in a significant number of patients.