Treatment of localized prostate cancer using high-intensity focused ultrasound

OBJECTIVE: To evaluate the biochemical disease-free survival (DFS), predictors of clinical outcome and morbidity of patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU), a noninvasive treatment that induces complete coagulative necrosis of a tumour at depth through the intact skin. PATIENTS AND METHODS: In all, 63 patients with stage T1c-2bN0M0 localized prostate cancer underwent HIFU using the Sonablate system (Focus Surgery, Inc., Indianapolis, IN, USA). None of the patients received neoadjuvant and/or adjuvant therapy. Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology consensus definition, i.e. three consecutive increases in prostate-specific antigen (PSA) level after the nadir. The median (range) age, PSA level and follow-up were 71 (45-87) years, 8.5 (3.39-57.0) ng/mL and 22.0 (3-63) months, respectively. RESULTS: The overall biochemical disease-free rate was 75% (47 patients). The 3-year biochemical DFS rates for patients with a PSA level before HIFU of <10, 10.01-20 and >20 ng/mL were 82%, 62% and 20% (P < 0.001), respectively. The 3-year biochemical DFS rates for patients with a PSA nadir of <0.2, 0.21-1 and >1 ng/mL were 100%, 74% and 21% (P < 0.001), respectively. Final follow-up sextant biopsies showed that 55 (87%) of the patients were cancer-free. Multivariate analysis showed that the PSA nadir (P < 0.001) was a significant independent predictor of relapse. CONCLUSION: HIFU therapy appears to be a safe, effective and minimally invasive therapy for patients with localized prostate cancer, and the PSA nadir is a useful predictor of clinical outcome.     

Transrectal high-intensity focused ultrasound for the treatment of localized prostate cancer: Eight-year experience

Objective:   To report on the long-term results of high-intensity focused ultrasound in the treatment of localized prostate cancer.
Methods:   A total of 517 men with stage T1c–T3N0M0 prostate cancer treated with Sonablate devices (Focus Surgery, Indianapolis, IN, USA) between January 1999 and December 2007 were included in the study. Biochemical failure was defined according to the Phoenix definition (prostate-specific antigen nadir + 2 ng/mL).
Results:   The median follow-up period for all patients was 24.0 months (range, 2 to 88). The biochemical disease-free rate (BDFR) in all patients at 5 years was 72%. The BDFR in patients with stage T1c, T2a, T2b, T2c and T3 groups at 5 years were 74%, 79%, 72%, 24% and 33%, respectively ( P  < 0.0001). BDFR in patients in the low, intermediate and high-risk groups at 5 years were 84%, 64% and 45%, respectively ( P  < 0.0001). The BDFR in patients treated with or without neoadjuvant hormonal therapy at 7 years were 73% and 53% ( P  < 0.0001), respectively. In multivariate analysis, pretreatment prostate-specific antigen levels (hazard ratio 1.060; P  < 0.0001; 95% confidence interval 1.040–1.080), neoadjuvant hormonal therapy (hazard ratio 2.252; P  < 0.0001; 95% confidence interval 1.530–3.315) and stage ( P  = 0.0189) were demonstrated to be statistically significant variables. Postoperative erectile dysfunction was noted in 33 out of 114 (28.9%) patients who were preoperatively potent.
Conclusions:   High-intensity focused ultrasound therapy appears to be minimally invasive, efficacious and safe for patients with localized prostate cancer, particularly those with low- and intermediate-risk cancer.     

Single session of high-intensity focused ultrasound therapy for the management of organ-confined prostate cancer: A single-institute experience

ObjectiveThe aim of this study was to evaluate the therapeutic response and complications of high-intensity focused ultrasound for patients with localized prostate cancer.Materials and MethodsWe evaluated the clinical outcomes of 29 patients who received high-intensity focused ultrasound as first-line treatment for localized prostate cancer at our hospital from October 2010 to March 2016. Biochemical recurrence was defined, according to the Stuttgart definition of biochemical failure, as the prostate-specific antigen nadir plus 1.2 ng/mL. Prostate-specific antigen levels and complications were recorded during regular follow-up.ResultsThe mean follow-up period was 24.6 months. Six patients experienced biochemical recurrence (20.68%). Disease progression was noted in six patients (20.68%), and salvage therapy was performed in these patients. The 24.6-month cancer-specific survival rate was 100%. No severe complications were reported.ConclusionHigh-intensity focused ultrasound is an alternative therapy for patients with localized prostate cancer. In combination with preceding transurethral resection of the prostate, this treatment shows promise in disease control with a low complication rate in short-term follow-up.     

Transrectal high-intensity focused ultrasound for treatment for patients with biochemical failure after radical prostatectomy

Four patients with biochemical prostate-specific antigen (PSA) failure with suspected local recurrence at the vesico-urethral anastomotic site after radical prostatectomy were treated using a high-intensity focused ultrasound (HIFU) device (Sonablate 500) under caudal or spinal anesthesia. The pretreatment PSA levels ranged from 0.318 to 0.898 ng/mL and their Gleason scores ranged between 5 and 7. HIFU treatment was carried out six times in four patients. The median time of operation and follow-up period were 30 min (range, 15-37) and 13 months (range, 7-18), respectively. In all patients, the median PSA levels decreased from 0.555 ng/mL (range, 0.318-0.898) to 0.137 ng/mL (range, 0.102-0.290). The median PSA nadir after each HIFU was 0.054 ng/mL (range, 0.008-0.097). No major complications were noted. HIFU may be useful for the therapy of vesicourethral anastomostic lesion in patients with PSA failure after prostatectomy.     

Morbidity associated with repeated transrectal high-intensity focused ultrasound treatment of localized prostate cancer

The aim of this cross-sectional study was to compare single with repeated high-intensity focused ultrasound (HIFU) treatment in patients with localized prostate cancer, regarding treatment-related morbidity. A number of 223 consecutive patients with localized prostate cancer were treated with HIFU. Among them, 174 (78%) patients had one treatment, while 49 (22%) needed a second treatment. The patients’ status and treatment-related side effects were followed up. The complications rates after one HIFU in 223 patients were: urinary tract infection 0.4%, chronic pelvic pain 0.9%, infravesical obstruction 19.7%, stressincontinence 7.6%, impotence 49.8%. Among the 49 patients who received a second HIFU therapy, the cumulative incontinence rate (12.2%; P = 0.024) and cumulative impotence rate (55%; P < 0.001) were significantly increased. Although there is an increase in morbidity if transrectal HIFU is repeated, the risk of side effects related to additional HIFU sessions in the case of primary treatment failure is still low.     

Prostate cancer outcomes following whole-gland and focal high-intensity focused ultrasound

Objective

To report the 5-year failure-free survival (FFS) following high-intensity focused ultrasound (HIFU).

Patients and Methods

This observational cohort study used linked National Cancer Registry data, radiotherapy data, administrative hospital data and mortality records of 1381 men treated with HIFU for clinically localised prostate cancer in England. The primary outcome, FFS, was defined as freedom from local salvage treatment and cancer-specific mortality. Secondary outcomes were freedom from repeat HIFU, prostate cancer-specific survival (CSS) and overall survival (OS). Cox regression was used to determine whether baseline characteristics, including age, treatment year, T stage and International Society of Urological Pathology (ISUP) Grade Group were associated with FFS.

Results

The median (interquartile range [IQR]) follow-up was 37 (20–62) months. The median (IQR) age was 65 (59–70) years and 81% had an ISUP Grade Group of 1–2. The FFS was 96.5% (95% confidence interval [CI] 95.4%–97.4%) at 1 year, 86.0% (95% CI 83.7%–87.9%) at 3 years and 77.5% (95% CI 74.4%–80.3%) at 5 years. The 5-year FFS for ISUP Grade Groups 1–5 was 82.9%, 76.6%, 72.2%, 52.3% and 30.8%, respectively (P < 0.001). Freedom from repeat HIFU was 79.1% (95% CI 75.7%–82.1%), CSS was 98.8% (95% CI 97.7%–99.4%) and OS was 95.9% (95% CI 94.2%–97.1%) at 5 years.

Conclusion

Four in five men were free from local salvage treatment at 5 years but treatment failure varied significantly according to ISUP Grade Group. Patients should be appropriately informed with respect to salvage radical treatment following HIFU.     

Transrectal high‐intensity focused ultrasound for treatment of localized prostate cancer

Objectives: To assess the long‐term outcomes of transrectal high‐intensity focused ultrasound (HIFU) for patients with localized prostate cancer. Methods: From May 2003 to present, 137 consecutive patients with T1‐2 prostate cancer were treated using the Sonablate 500 and then followed for more than 12 months after their last HIFU treatment. A prostate biopsy was routinely carried out at 6 months and serum prostate‐specific antigen (PSA) was measured every 3 months after HIFU. Oncological outcomes as well as treatment‐related complications were assessed. Disease‐free survival (DFS) was judged using the Phoenix definition (PSA nadir + 2 ng/mL), negative histological findings and no local or distant metastasis. Results: The median follow up after HIFU was 36 months (range 12–84 months). No patients received adjuvant therapy during this period. The PSA nadir occurred at 2 months after HIFU and the median level was 0.07 ng/mL (0.01–2.01 ng/mL). Of the 133 patients who underwent prostate biopsy or transurethral resection of the prostate at 6 months or later after HIFU, six were positive for cancer cells (4.5%). There were no major postoperative complications, but urge incontinence (16 cases) and dysuria (33 cases) occurred after removal of the urethral catheter. The 5‐year DFS rate was 78% based on these criteria, and 91%, 81% and 62% in the low‐, intermediate‐ and high‐risk group, respectively. Conclusions: HIFU represents an effective, repeatable and minimally invasive treatment. It is particularly effective for low‐ and intermediate‐risk patients, and it should be considered as an option for localized prostate cancer.     

Location of residual cancer after transrectal high-intensity focused ultrasound ablation for clinically localized prostate cancer

Study Type – Therapy (case series) Level of Evidence 4 What’s known on the subject ? and What does the study add? Transrectal High‐Intensity Focused Ultrasound (HIFU) ablation has been used as a minimally invasive treatment for localized prostate cancer for 15 years. Five‐year disease‐free survival rates of 66–78% have been reported, challenging the results of external‐beam radiation therapy. Usually, a 6‐mm safety margin is used in the apex to preserve the urinary sphincter and potency. The influence of this 6‐mm margin on the results of the treatment has never been assessed. This retrospective study of a cohort of 99 patients who underwent systematic biopsy 3–6 months after HIFU ablation for prostate cancer (with a 6‐mm safety margin in the apex) shows that post‐HIFU residual cancer is found more frequently in the apex. Therefore, new strategies improving the prostate destruction at the apex while preserving the urinary continence need to be found.

OBJECTIVE

? To evaluate whether the location (apex/midgland/base) of prostate cancer influences the risk of incomplete transrectal high‐intensity focused ultrasonography (HIFU) ablation.

PATIENTS AND METHODS

? We retrospectively studied 99 patients who underwent prostate cancer HIFU ablation (Ablatherm; EDAP, Vaulx‐en‐Velin, France) with a 6‐mm safety margin at the apex, and had systematic biopsies 3–6 months after treatment. ? Locations of positive pre‐ and post‐HIFU sextants were compared. ? The present study included two analyses. First, sextants negative before and positive after treatment were recoded as positive/positive, hypothesizing that cancer had been missed at pretreatment biopsy. Second, patients with such sextants were excluded.

RESULTS

? Pre‐HIFU biopsies found cancer in all patients and in 215/594 sextants (36.2%); 55 (25.6%) positive sextants were in the apex, 86 (40%) in the midgland and 74 (34.4%) in the base. ? After treatment, residual cancer was found in 36 patients (36.4%) and 50 sextants (8.4%); 30 (60%) positive sextants were in the apex, 12 (24%) in the midgland and eight (16%) in the base. ? Both statistical analyses found that the locations of the positive sextants before and after HIFU ablation were significantly different (P < 0.001), with a higher proportion of positive apical sextants after treatment. ? At the first analysis, the mean (95% confidence interval) probability for a sextant to remain positive after HIFU ablation was 8.8% (3.5–20.3%) in the base, 12.7% (5.8–25.9%) in the midgland and 41.7% (27.2–57.89%) in the apex. ? At the second analysis, these same probabilities were 5.9% (1.9–17%), 9.9% (3.9–23.2%) and 27.3% (13.7–47%), respectively.

CONCLUSION

? When a 6‐mm apical safety margin is used, residual cancer after HIFU ablation is found significantly more frequently in the apex.     

经直肠高强度聚焦超声破坏犬前列腺组织的实验研究

目的探讨经直肠高强度聚焦超声(high-intensity focused ultrasound,HIFU)破坏犬前列腺组织的的安全性、可行性和有效性。方法采用美国Focus Surgery公司生产的第三代HIFUSonablate-500型治疗仪,对16只犬的前列腺进行消融处理,在消融术前,术后30min、30d、60d和180d,经直肠超声观察前列腺和前列腺部尿道的影像学变化;切取前列腺及临近组织和器官,观察其组织病理学变化。结果HIFU前列腺消融术前,前列腺体积为(6.50±3.12)cm3,前列腺部尿道的最大宽度为(0.59±0.11)cm;HIFU消融术60天后前列腺体积为(4.13±2.03)cm3,前列腺部尿道最大宽度为(2.57±0.98)cm。HIFU前列腺消融术后组织学检查,可见前列腺靶区内腺体腺上皮及基质细胞发生均匀性凝固性坏死,60d后消融区的坏死组织脱落,前列腺部尿道呈囊腔状。HIFU前列腺消融区凝固性坏死与正常前列腺组织分界清楚,消融区以外的前列腺及临近组织和器官均无副损伤。HIFU前列腺消融术后并发症主要有尿潴留、尿频和血尿,各实验犬均未发生尿道直肠瘘等并发症。结论HIFU前列腺消融术可彻底破坏消融区的前列腺组织,显著增加前列腺部尿道宽度,对消融区以外的临近组织和器官无副损伤。HIFU前列腺消融术,有望成为临床治疗前列腺疾病的一种可选择的、安全和有效的微创治疗方法。     

超声造影评价高强度聚焦超声治疗局限性前列腺癌早期疗效的临床研究

目的 探讨超声造影对高强度聚焦超声（HIFU）治疗局限性前列腺癌早期疗效评价的应用价值.方法 采用HIFU-2001型高强度聚焦超声肿瘤治疗系统,对17例局限性前列腺癌进行治疗.治疗前及治疗后1个月分别行超声造影检查,观察瘤体内部及周边组织血流灌注信号特点,据此判定疗效.同时根据直肠指检、经直肠前列腺B超检查前列腺肿块大小、血清PSA等结果进行客观疗效判定.将两疗效判定结果进行对比分析.结果 HIFU治疗前,所有前列腺低回声结节均呈快速高增强.HIFU治疗后,超声造影显示治疗有效15例,其中无增强12例、少量低增强3例;无效2例,仍表现为快速高增强.客观疗效判定有效15例,血清PSA下降幅度均≥50%,其中2例前列腺结节体积缩小≥50%;无效2例,血清PSA、前列腺低回声结节大小体积均与治疗前水平相当.客观疗效判定结果与超声造影结果相符.结论 超声造影能准确显示HIFU治疗局限性前列腺癌的消融范围及程度,是评价早期治疗效果的可靠方法.     

Six years' experience with high-intensity focused ultrasonography for prostate cancer: oncological outcomes using the new 'Stuttgart' definition for biochemical failure

Study Type – Therapy (outcomes research) Level of Evidence 2b

OBJECTIVE

? To determine oncological outcomes after high‐intensity focused ultrasonography (HIFU) treatment in patients with localized prostate cancer using a new, more accurate, definition (‘Stuttgart’ definition) of biochemical failure.

PATIENTS AND METHODS

? We performed a retrospective review of all patients in our centre who received first‐line treatment with a second‐generation Ablatherm^TM device (EDAP‐TMS, Lyon, France). ? Oncological failure was given either by biochemical failure (prostate‐specific antigen, PSA, nadir plus 1.2 g/mL) (Stuttgart definition) or the start of salvage therapy because of a persistently positive biopsy after the HIFU procedure. ? The 5‐year biochemical‐free survival rate and 5‐year disease‐free survival rate were calculated.

RESULTS

? In total, 53 patients were included (mean age, 72.5 ± 4.5 years, range 60–79 years; 28 low risk and 25 intermediate risk). None had undergone previous hormonal therapy. Mean ±sd follow‐up was 45.4 ± 15.5 months (range 16–71 years). Mean (range) pre‐treatment PSA was 8.5 ± 4 (0.29–18) ng/mL. The median (range) PSA nadir value was 1 (0.01–14) ng/mL and occurred after a mean (range) of 5.09 (3–24) months. ? Overall, 36 patients (67.9%) experienced oncological failure. ? These included 33 cases (62.2%) of biochemical failure. A PSA nadir of ≤0.2, 0.21–1.0 and >1 ng/mL was reached in 20.8%, 30.2% and 49% of patients, respectively, and was associated with biochemical failure in 9.1%, 30.3% and 60.6%, respectively. ? The 5‐year biochemical‐free survival rate and disease‐free survival rate were 21.7% and 13.5%, respectively. In multivariate analysis, a PSA nadir of >1 ng/mL was significantly associated with a risk of biochemical and oncological failure (P= 0.002 and P < 0.001). ? Oncological failure was not associated with any risk group. ? No patient died from prostate cancer.

CONCLUSIONS

? In our experience, Ablatherm^TM treatment for clinically localized prostate cancer was associated with a high rate of biochemical failure as determined by the ‘Stuttgart’ definition, and did not achieve effective cancer control. ? The PSA nadir value after HIFU treatment was a significant predictor of treatment failure.     

高强度聚焦超声系统治疗局限性前列腺癌（附26例报告）

目的探讨高强度聚焦超声系统(HIFU)治疗局限性前列腺癌的有效性及安全性。方法使用Sonablate-500聚焦超声系统对26例局限性前列腺癌患者进行治疗,观察术后3、6、12个月时的血清前列腺特异性抗原(PSA)、直肠指诊及经直肠B超情况。结果平均手术操作时间48min(28～86min),平均术后住院时间3.2d(2～9d)。治疗后3、6、12个月PSA与治疗前相比有显著降低(P<0.05),直肠指诊发现结节消失或减小的占73.3%(11/15),B超提示:低回声结节消失或缩小的占76.9%(20/26)。治疗后3、6、12个月各项检查结果经统计学检验无显著性差异。结论HIFU可以安全、有效杀死前列腺癌细胞,在治疗局限性前列腺癌方面具有美好的应用前景。     

高强度超声聚能系统治疗激素难治性前列腺癌临床疗效观察

目的:探讨经直肠高强度聚焦超声(high-intensity focused ultrasound,HIFU)治疗激素难治性前列腺癌的有效性及安全性.方法:采用美国Focus Surgery公司生产的第三代HIFU Sonablate-500型治疗仪,对22例激素难治性前列腺癌患者进行治疗.根据直肠指检和经直肠前列腺B超检查前列腺肿块大小、血清PSA、ECT骨扫描等将疗效分为完全反应(CR)、部分反应(PR)、病情稳定(SD)、病情恶化(PD).主观症状根据骨痛、排尿异常、血尿等症状的变化分为症状消失、症状改善、症状平稳、症状加剧.结果:经HIFU治疗,CR 6例,占27.3%(6/22);PR 11例,占50.0%(11/22);SD 4例,占18.2%(4/22);PD1例,占4.5%(1/22).总有效率(CR PR)达到77.3%(17/22).主观症状消失9例,占40.9%(9/22);症状改善6例,占27.3%(6/22);症状稳定3例,占13.6%(3/22);症状加剧4例,占18.2%(4/22).主观症状总改善率(症状消失 症状改善)达到68.2%(15/22).3例伴有血尿者均控制良好.术后并发症:3例发生附睾炎,无尿道狭窄、尿失禁、阳痿、尿道直肠瘘并发症发生.结论:HIFU对激素难治性前列腺癌的治疗有效、安全,为微创治疗激素难治性前列腺癌提供了新的途径.     

高强度聚焦超声联合低剂量放疗作为进展期前列腺癌内分泌治疗后补充治疗的有效性和安全性分析

本研究旨在评估高强度聚焦超声（high-intensity focused ultrasound,HIFU）联合（＋）低剂量外放疗（low—dose external beam radiotherapy,LRT）作为进展期前列腺癌内分泌治疗（hormonal therapy,HT）后补充治疗的有效性和安全性。我们定义的HIFU＋LRT是指采用HIFU治疗前列腺癌原发灶,取代前列腺及精囊区的缩野外放疗,而仅保留传统外放疗（conventional—dose external beam radiotherapy,CRT）中盆腔的四野照射。我们对进展期前列腺癌内分泌治疗后的120例患者进行了非随机的前瞻性对照研究,分别接受HIFU、CRT、HIFU＋LRT、和单纯HT治疗。CT／MRI影像学检查显示HIFU＋LRT治疗后原发肿瘤和盆腔淋巴结转移灶明显萎缩甚至消失。四组间的总体和疾病特异生存曲线（P=0．018和O．015）均存在显著差异。进一步行各组两两比较提示HIFU＋LRT组的长期疾病特异生存率高于其它3组,但HIFU＋LRT组与CRT组的差异无显著性。多因素COX比例风险模型证实HIFU＋LRT和CRT均单独和DSS相关（P=O．001和O．035）,对死亡风险有显著保护作用。与cRT比较,HIFU＋LRT能显著减少放疗相关的远期泌尿道及消化道II级或以上严重并发症的发生率。总而言之,进展期前列腺癌采用内分泌治疗后,进一步加强原发灶和区域淋巴结转移灶的治疗能有效提高患者的长期生存。作为替代常规剂量外放疗的选择之一,HIFU＋LRT显示了良好疗效和更高的安全性。     

经直肠高强度聚焦超声系统治疗前列腺癌57例疗效分析

目的:探讨经直肠高强度聚焦超声系统(HIFU)治疗PCa的疗效。方法:使用Sonablate500型经直肠HIFU治疗系统,对57例PCa患者进行HIFU治疗,其中局限性PCa27例,晚期PCa30例。在确定生化复发之前,对局限性PCa仅行经直肠HIFU治疗;对于晚期PCa,在行经直肠HIFU治疗的同时,联合应用内分泌治疗。结果:HIFU治疗平均手术操作时间为111(86～153)min,平均术后住院时间为3.2(2～18)d。平均随访时间18(6～30)个月。局限性PCaHIFU治疗后,生化检查阴性率(PSA(4.0μg/L)在治疗后的1、2、3年分别为86%、81%和79%。30例晚期PCa治疗平均8个月(3～24个月)后,26例血清PSA<4.0μg/L(其中20例血清PSA<0.5μg/L)、21例患者前列腺体积缩小>50%。治疗后6个月时与治疗前相比,前列腺体积缩小、PSA水平降低、Qmax增加及IPSS改善差异均有显著性(P<0.05)。HIFU治疗后无严重尿道直肠瘘、尿失禁等并发症发生。结论:经直肠HIFU治疗PCa,安全、有效,并发症少,近期疗效较好,是一种可选择的PCa微创治疗方法。     

Extracorporeally induced ablation of renal tissue by high-intensity focused ultrasound

OBJECTIVE: To investigate the safety and the effects on healthy renal tissue of high-intensity focused ultrasound (HIFU) applied extracorporeally. PATIENTS, MATERIALS AND METHODS: Ultrasound waves (1.04 MHz) created by a cylindrical piezo-ceramic element were focused by a parabolic reflector to a physical focus size of 32 x 4 mm (-6 dB). For an in vivo study, HIFU was applied to the healthy tissue of 24 kidneys, monitored by ultrasonography, with a maximum power of 400 W and a spatially averaged intensity (ISAL) in the focus of 1192 W/cm(2). Fourteen kidneys were removed immediately after ablation to evaluate the side-effects and the effects in the focal zone, and 10 kidneys were removed delayed after 1, 7 and 10 days. The clinical study consisted of 19 patients requiring radical nephrectomy for a renal tumour. HIFU was applied to the healthy tissue of 19 kidneys (up to 1600 W, I(SAL) = 4768 W/cm(2)) before proceeding with the radical nephrectomy. RESULTS: There were no major complications after applying HIFU to the 43 kidneys. Side-effects included skin burns (grade 3) in two patients. During the follow-up there were no further HIFU-specific side-effects. In one case (in vivo study) there was a thermal lesion of the small intestine, which was due to mis-focusing. HIFU effects in the focal zone immediately after application were: interstitial haemorrhages, fibre rupture, shrinking of the collagen fibres, and coagulation necrosis. These effects occurred sporadically, and their number and size did not correspond to the number of HIFU pulses applied. After 7 and 10 days, there was a well-demarcated coagulation necrosis in vivo. CONCLUSION: Using this device, extracorporeally applied HIFU can ablate healthy kidney tissue in vivo in combination with diagnostic online ultrasonography. The technique is safe and resulted only in minor complications (skin burns). Refinements in the technology are essential to establish HIFU as a noninvasive treatment option that allows complete and reliable tissue ablation.     

Quality of life following high‐intensity focused ultrasound for the treatment of localized prostate cancer: A prospective study

Objectives: To report our health‐related quality of life (QOL) and functional outcomes following high‐intensity focused ultrasound (HIFU) for localized prostate cancer. Methods: Data from prostate cancer patients undergoing HIFU at our institution between January 1999 and April 2007 were collected in our prospective database. Standard preoperative and surgical parameters, as well as baseline urinary function, QOL and sexual assessment were included. The Japanese version of the Functional Assessment of Cancer Therapy‐general (FACT‐G), the FACT‐prostate (P) and the International Index of Erectile Function‐5 (IIEF‐5) were used for the functional assessment. These self‐administered questionnaires were collected preoperatively and again at 6, 12 and 24 months postoperatively. Results: A total of 326 patients were included in the analysis. Maximum flow rate and residual urine volume were significantly impaired at 6 months (P = 0.010) after HIFU, even if they returned to baseline values at 12 or 24 months after HIFU. The total FACT‐G score significantly improved at 24 months (P = 0.027) after HIFU. At 6, 12 and 24 months after HIFU, 52%, 63% and 78%, respectively, of the patients, not receiving neoadjuvant hormonal therapy, were potent. Conclusions: In our experience, functional and QOL outcomes after HIFU therapy for localized prostate cancer are better than those after other treatment modalities.     

Laparoscopic high-intensity focused ultrasound for renal tumours: a proof of concept study

Study Type – Therapy (case series)
Level of Evidence What’s known on the subject? and What does the study add? Renal cancer is increasingly diagnosed when tumours are small and asymptomatic, during routine abdominal imaging. Whilst surgery is an effective and potentially curative option, it carries a significant risk of complications. Recent work suggests that thermally ablative therapies (RFA, cryotherapy, HIFU) may be suitable minimally invasive treatment options in selected patients. The success of extracorporeal HIFU has been limited by the abdominal wall and rib‐cage limiting energy delivery. For this study, a purpose‐built laparoscopic HIFU probe was designed to allow direct application of the transducer to the tumour surface, thus facilitating tumour destruction. Successful and accurate tumour destruction was demonstrated, paving the way for further clinical trials, subject to device modifications.

OBJECTIVE

• ? To test and establish clinical proof of concept for a laparoscopic high‐intensity focused ultrasound (HIFU) device that facilitates delivery of ultrasound by direct application of a probe to the tumour surface.

PATIENTS AND METHODS

• ? Twelve patients with renal tumours were treated with laparoscopic HIFU using a newly designed probe inserted via an 18‐mm laparoscopic port.
• ? HIFU treatment was targeted at a pre‐defined proportion of the tumour and immediate laparoscopic partial or radical nephrectomy was then performed.

RESULTS

• ? No tumour ablation was seen in the first five patients which made modifications in the treatment protocol necessary. After this, definite histological evidence of ablation was seen in the remaining seven patients.
• ? The ablated zones were within the targeted area in all patients and no intra‐lesional skipping was seen.
• ? Subcapsular skipping was seen at the probe–tumour interface in two patients with viable tumour cells seen at microscopy.
• ? One patient did not undergo surgical extirpation; subsequent biopsy revealed no viable tumour cells.
• ? There were no intraoperative or postoperative complications directly related to HIFU therapy and patients have reached a mean (range) follow‐up of 15 (8–24) months with no evidence of metastatic disease or late complications.

CONCLUSIONS

• ? Tumour ablation with laparoscopic HIFU is feasible.
• ? Homogenous ablation can be achieved with no vital tissue within the targeted zone.
• ? The technique is associated with low morbidity and may have a role in the definitive management of small tumours.