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.     

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.     

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.     

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.     

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.     

Five years experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate cancer

BACKGROUND: High-intensity focused ultrasound (HIFU) is a minimally invasive technique used in achieve coagulation necrosis. We evaluated biochemical disease-free survival rates, predictors of clinical outcome and morbidity in patients with localized prostate cancer treated with HIFU. METHODS: A total of 181 consecutive patients underwent HIFU with the use of Sonablate (Focus Surgery, Indianapolis, IN, USA). Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology Consensus Panel. The median age and pretreatment prostate-specific antigen (PSA) level were 70 years (range 44-88) and 9.76 ng/mL (range 3.39-89.60). A total of 95 patients (52%) were treated with neoadjuvant hormones. The median follow-up period for all patients was 18.0 months (range 4-68). RESULTS: The biochemical disease-free survival rates at 1, 3 and 5 years in all patients were 84%, 80% and 78%, respectively. The biochemical disease-free survival rates at 3 years for patients with pretreatment PSA less than 10 ng/mL, 10.01-20.0 ng/mL and more than 20.0 ng/mL were 94%, 75% and 35%, respectively (P<0.0001). Multivariate analysis identified pretreatment PSA (P<0.0001) as a independent predictor of relapse. CONCLUSION: High-intensity focused ultrasound therapy appears to be a safe and efficacious minimally invasive therapy for patients with localized prostate cancer, especially those with a pretreatment PSA level less than 20 ng/mL.     

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.     

Short-term outcome after high-intensity focused ultrasound in the treatment of patients with high-risk prostate cancer

OBJECTIVE: To assess the short-term outcome in patients with high-risk prostate cancer treated by transrectal high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS: From April 2003 to November 2004, 30 patients with high-risk prostate cancer were enrolled in this prospective study; all had transurethral resection of the prostate before transrectal HIFU treatment, using the Ablatherm device (EDAP, Lyon, France) during the same session, associated with hormonal therapy with luteinizing hormone-releasing hormone analogues. After the procedure, all the patients were evaluated every 3 months by physical examination, prostate-specific antigen (PSA) assay and a continence questionnaire. The follow-up schedule also included a transperineal prostate biopsy 6 months after the treatment. All the patients had a minimum follow-up of 12 months. RESULTS: The HIFU treatment took a median (interquartile range, IQR) of 140 (100-160) min. No complications were reported during treatment. The mean (IQR) hospitalization was 2.2 (1-4) days, and the suprapubic drainage tube was removed after 12 (7-18) days. The complications after treatment were: urinary tract infections in five patients (16%), stenosis of the intraprostatic and membranous urethra in three (10%), and secondary infravesical obstruction in four (13%). At 12 months after the procedure, 28 patients (93%) were continent. Seven of the 30 men (23%) had a positive prostate biopsy. At the 1-year follow-up only three of the 30 patients with high-risk prostate cancer had a PSA level of >0.3 ng/mL. CONCLUSIONS: HIFU is a modern, minimally invasive therapy for prostate cancer, often used in selected patients with localized disease. The present results show that HIFU was also feasible in patients with high-risk prostate cancer. The low complication rates and favourable functional outcome support the planning of further larger studies in such patients. The oncological efficacy of HIFU should be assessed in further studies with a longer follow-up.     

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。     

Salvage robotic-assisted laparoscopic radical prostatectomy following failed primary high-intensity focussed ultrasound treatment for localised prostate cancer

We report the first case of salvage robotic-assisted laparoscopic radical prostatectomy (RALP) following failed primary high-intensity focussed ultrasound (HIFU) for localised carcinoma of the prostate. A 66-year-old male with a presenting prostate-specific antigen (PSA) of 5 ng/ml was diagnosed with T1c Gleason 3 + 4 prostate cancer. He underwent transurethral resection of the prostate and HIFU. His PSA dropped to 2.0 ng/ml and repeat biopsy revealed upgrading of his prostate cancer to Gleason 4 + 3. He was referred to us for a second opinion and, following discussion of his options, he underwent RALP. The total operative time was 159 min. There were no intra- or postoperative complications. He was discharged on postoperative day two and was fully continent 10 days following removal of his catheter. His PSA remained undetectable 6 months postoperatively. Salvage RALP was feasible in this case with good functional and short-term oncological outcomes for the patient.     

A review on radiofrequency,microwave and high-intensity focused ultrasound ablations for hepatocellular carcinoma with cirrhosis

ImportanceHepatocellular carcinoma (HCC) is usually accompanied by liver cirrhosis, which makes treatment of this disease challenging. Liver transplantation theoretically provides an ultimate solution to the disease, but the maximal surgical stress and the scarcity of liver graft make this treatment option impossible for some patients. In an ideal situation, a treatment that is safe and effective should provide a better outcome for patients with the dilemma.ObjectiveThis article aims to give a comprehensive review of various types of loco-ablative treatment for HCC.Evidence ReviewLoco-ablative treatment bridges the gap between surgical resection and transarterial chemotherapy. Various types of ablative therapy have their unique ability, and evidence-based outcome analysis is the most important key to assisting clinicians to choose the most suitable treatment modality for their patients.FindingsRadiofrequency ablation (RFA) has a relatively longer history and more evidence to support its effectiveness. Microwave ablation (MWA) is gaining momentum because of its shorter ablation time and consistent ablation zone. High-intensity focused ultrasound (HIFU) ablation is a relatively new technology that provides non-invasive treatment for patients with HCC. It has been carried out at centers of excellence and it is a safe and effective treatment option for selected patients with HCC and liver cirrhosis.Conclusion and RelevanceSelective use of different loco-ablative therapies will enhance clinicians’ treatment options for treatment of HCC.     

High‐intensity focused ultrasound for localized prostate cancer: initial experience with a 2‐year follow‐up

OBJECTIVE

To report on the short‐term functional and oncological results, from one institution, of high‐intensity focused ultrasound (HIFU) for treating localized prostate cancer.

PATIENTS AND METHODS

Over a 3‐year period, 43 patients with localized prostate cancer were scheduled for HIFU in the primary (31) and salvage (12) settings using a second‐generation Ablatherm^TM device (EDAP, Lyon, France). Oncological failure was defined by several criteria, including biochemical failure (assessed using both the Phoenix definition of the nadir + 2 ng/mL) and the current Food and Drug Administration (FDA) trial endpoint of a prostate‐specific antigen (PSA) level of ≥0.5 ng/mL, or starting salvage therapy, or the presence of cancer on biopsy after treatment.

RESULTS

Three patients had their procedures abandoned due to technical limitations/rectal wall thickness. The mean PSA levels in the primary and salvage groups were 9.2 and 5.1 ng/mL, respectively. The mean HIFU treatment time in the primary and salvage groups was 71.1 and 63.3 min, respectively. Using the Phoenix definition of biochemical failure, HIFU treatment failed in 13 patients in the primary group (46%) and five in the salvage group. Using the FDA trial endpoint, HIFU failed in 21 patients in the primary group (75%) and eight in the salvage group. One man died from metastatic prostate cancer 18 months after salvage HIFU. There were two urethral strictures in the primary (7%) and one in the salvage treatment group. There were two prostato‐rectal fistulae in the salvage HIFU group.

CONCLUSIONS

HIFU is proposed to be a minimally invasive low‐morbidity ablative treatment for localized prostate cancer, and with good efficacy. The present limited series is unable to support these claims. There were significant rates of complications and oncological failure in both the primary and salvage setting. As a result we have suspended our programme pending further evidence of its safety and efficacy.     

相变纳米液滴和微泡增强HIFU在体模中所致凝固性坏死的对比

目的 对比研究相变纳米液滴-包裹相变温度29℃的全氟戊烷的脂质纳米液滴(L-PFP)和微米级微泡(SonoVue)增强HIFU在体模中的消融效果.方法 分别将0.3 ml的生理盐水、L-PFP和SonoVue各自加入到100 ml的蛋清体模中,制成对照组、L-PFP组、SonoVue组.然后在B超引导下进行HIFU定点辐照,声功率100 W、辐照时间10 s、辐照深度14 mm.比较3组辐照前后凝固性坏死的体积和能效因子(EEF).结果 辐照后即刻,B超图像上3组的靶区均出现强回声,L-PFP组强回声范围最大;HIFU在体模中形成的凝固性坏死体积为L-PFP组 >SonoVue组 >对照组(P <0.05);3组的EEF为对照组 >SonoVue组 >L-PFP组(P <0.05).HIFU辐照过程中L-PFP组的开始温升速度和最高温度均大于SonoVue组.结论 与微米级微泡相比,相变脂质纳米液滴的对HIFU辐照的增效效果更加明显.     

超声引导高强度聚焦超声治疗肌壁间子宫肌瘤的效果

目的探讨超声引导高强度聚焦超声(HIFU)治疗肌壁间子宫肌瘤的效果及其对前、后壁子宫肌瘤疗效的差异。方法对54例症状性肌壁间子宫肌瘤患者行超声引导下HIFU治疗;消融后当日或次日及术后3个月时行增强MR检查,评估肌瘤消融范围并计算消融率:消融率≥50%为显效,0<消融率<50%为有效,增强信号无减低为消融无效。结果共消融治疗肌壁间子宫肌瘤57个,其中前壁肌瘤32个,后壁肌瘤25个;消融前肌瘤体积为16.27～502.12cm3,消融后增强MRI显示无灌注区域体积为5.75～292.42cm3,平均消融率为(68.14±16.19)%,显效率为89.47%(51/57),有效率为100%(57/57)。3个月后消融肌瘤无灌注区域体积较术后1天或次日进一步缩小(t=6.365,P<0.05)。前壁肌瘤平均消融率为(74.35±12.24)%,后壁肌瘤平均消融率为(60.93±17.62)%,差异有统计学意义(t=2.366,P<0.05)。结论超声引导HIFU治疗肌壁间子宫肌瘤安全、有效,对前壁肌瘤的消融率高于后壁肌瘤。     

Control of prostate cancer by transrectal HIFU in 227 patients

PURPOSE: To evaluate the results of high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer with reference to disease-related prognostic factors. MATERIALS AND METHODS: Patients with T1-2 localized prostate cancers, prostate specific antigen (PSA) 1 ng/ml with three consecutive rises. RESULTS: The study included 227 patients. Mean follow-up was 27+/-20 months (12-121 months). Eighty-six percent had negative control biopsies. Median nadir PSA was 0.10 ng/ml. The actuarial 5-year disease-free survival rate (DFSR), combining pathologic and biochemical outcomes, was 66%. DFSR showed a significant decrease when stratified according to initial PSA level: 90% with PSA 相似文献   

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.     

Salvage high‐intensity focused ultrasound for biopsy‐confirmed local recurrence of prostate cancer after radical prostatectomy

Study Type – Therapy (case series)
Level of Evidence 4

OBJECTIVE

To present experience in high‐intensity focused ultrasound (HIFU) used as a salvage therapy for biopsy‐confirmed local recurrence at the vesico‐urethral anastomosis after radical prostatectomy (RP).

PATIENTS AND METHODS

From July 2006, four patients diagnosed with prostate cancer recurrence after RP were treated with HIFU, with or without salvage radiotherapy, using the Sonablate® 500 (Focus Surgery, IN, USA). Biochemical failure was defined as in increase in prostate‐specific antigen (PSA) level of >0.2 ng/mL. No patients received any adjuvant therapy after HIFU therapy before reporting failure.

RESULTS

The mean age and initial PSA level before RP was 74 years and 10.0 ng/mL, respectively. After RP, one patient was stage T2aN0M0, two were stage T3N0M0 and the last had an unknown pathological stage. Three patients received external beam radiotherapy as salvage therapy after RP. The mean PSA level before HIFU, tumour volume at the vesico‐urethral lesion and operative duration were 4.3 ng/mL, 4.6 mL and 27 min, respectively. Adenocarcinomas were confirmed by biopsy of the tumour at the vesico‐urethral anastomotic lesion before HIFU. At 24 months of follow‐up, patients 2 and 4 were classified a biochemically disease‐free. Biopsies at the anastomotic site after HIFU in three patients showed no malignancy, with fibrosis. There were no complications.

CONCLUSION

Salvage HIFU for patients with recurrence after RP is feasible, even though they received salvage radiotherapy before HIFU. More patients and a longer follow‐up are needed to evaluate the safety and oncological adequacy of this new approach.     

Single-session primary high-intensity focused ultrasonography treatment for localized prostate cancer: biochemical outcomes using third generation-based technology

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? The experience with HIFU as a minimally invasive treatment for localized prostate cancer is relatively new and most reports are from European centres. Our study is unique in five regards: 1. Data was collected prospectively. 2. All patients were treated with contemporary technology. 3. Outcomes are reported after a single HIFU session using two definitions of biochemical failure that have the ability to predict longer‐term clinical failure after primary ablative therapies for prostate cancer (Stuttgart definition for HIFU and Horwitz definition for radiation). 4. All patients were treated in a single centre. 5. No patients underwent peri‐HIFU TURP. The present study represents the largest North American prospective cohort of primary HIFU for prostate cancer with mid‐term oncological outcome data.

OBJECTIVE

• ? To assess 4‐year biochemical failure (BCF) rates in patients after high‐intensity focused ultrasonography (HIFU) treatment using the Horwitz and Stuttgart definitions.

PATIENTS AND METHODS

• ? A total of 447 consecutive patients were treated with a single session of HIFU between May 2005 and December 2010.
• ? Follow‐up included prostate‐specific antigen (PSA) measurement every 3 months during the first year and every 6 months thereafter.
• ? Patients who had previously received radiation, androgen deprivation or HIFU therapy, and patients with <2 consecutive PSA measurements were excluded.
• ? BCF was reported using the Stuttgart (PSA nadir + 1.2 ng/mL rising) and the Horwitz (two consecutive increases of at least 0.5 ng/mL) definitions.

RESULTS

• ? In all, 402 patients met the inclusion criteria and the median (range) follow‐up was 24 (6–48) months.
• ? Of these patients, 183 (45.5%) had low and 219 (54.5%) had intermediate D'Amico's risk stratification disease.
• ? Mean and median absolute PSA nadir levels were 0.36 ± 0.69 and 0.1 ng/mL (Q₁:0, Q₃:0.37), respectively and these were achieved in median time of 3 months.
• ? Overall 4‐year mean (range) BCF‐free rates were 68 (61–75)% and 72 (68–77)% according to the Stuttgart and Horwitz definitions at 4 years, respectively.
• ? Mean (range) BCF‐free rates were significantly higher for a PSA nadir ≤0.5 ng/mL and prostate volume ≤30 mL for both definitions at 4‐year follow‐up [Stuttgart: 79 (72–86)% vs. 25 (13–38)%; Horwitz: 82 (77–87)% vs. 33 (21–44)%] and [Stuttgart: 72 (64–79)% vs. 56 (42–69)%; Horwitz: 75 (69–80)% vs. 63 (53–74)%], respectively.
• ? Pre‐treatment PSA and PSA nadir of >0.5 ng/mL were the predictors of BCF using both definitions.

CONCLUSIONS

• ? Primary HIFU appears to result in promising 4‐year BCF‐free rates in individuals with low‐ and intermediate‐risk prostate cancer who achieve PSA nadir <0.5 ng/mL.
• ? A prostate volume <30 mL is associated with PSA nadir levels of <0.5 ng/mL suggesting a potential role for pretreatment volume reduction (medically or surgically) in larger prostates.