High-intensity Focused Ultrasonography Research Articles

Oncological results and cancer control definition in focal therapyfor Prostate Cancer: a systematic review.

Focal therapy (FT) is a promising alternative to whole-gland treatments for Localized Prostate Cancer. Ten different FT modalities have been described in literature. However, FT is not yet recommended by the International Guidelines, due to the lack of robust data on Oncological Outcomes. The objective of our Narrative Review is to evaluate the oncological profile of the available FT modalities and to offer a comprehensive overview of the definitions of Cancer Control for FT. Literature search was performed on 21stFebruary 2023 using PubMed, EMBASE, and Scopus, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA). Articles reporting whole gland-treatments were excluded. All articles reporting oncological outcomes were included. One-hundred-twenty-four studies, reporting data on more than 8000 patients treated with FT, were included. Overall, 40 papers were on High Intensity Focal Ultrasound (HIFU), 24 on Focal Cryotherapy, 13 on Irreversible Electroporation (IRE), 11 on Focal brachytherapy, 10 on Focal Laser Ablation (FLA), 8 on Photo-Dynamic Therapy (PDT), 3 on Microwave ablation, 3 on Robotic Partial Prostatectomy, 2 on bipolar Radio Frequency Ablation (bRFA), 1 on Prostatic Artery Embolization (PAE) and 9 comparative papers. Overall, the Biochemical Recurrence (BCR) rate ranged from 0% (Focal Brachytherapy) to 67.5% (HIFU); the Salvage treatment rate ranged from 1% (IRE) to 54% (HIFU) considering re-treatment with FT and from 0% (Focal Brachytherapy) to 66.7% considering standard Radical Treatments. There is no univocal definition of Cancer Control, however the "Phoenix criteria" for BCR were the most commonly used. FT is a promising alternative treatment for localized prostate cancer in terms of Oncological Outcomes, however there is a wide heterogeneity in the definition of cancer control, the reporting of oncological outcomes and a lack of high-quality clinical trials. Solid comparative studies with standard treatments and an unambiguous consensus on how to describe Cancer Controlin the field of Focal Therapyare needed.

Functional Outcomes after Local Salvage Therapies for Radiation-Recurrent Prostate Cancer Patients: A Systematic Review.

Simple SummaryLocal salvage therapies are offered to prostate cancer (PCa) patients with recurrent disease following primary radiation therapy with initial curative intent. Favorable oncologic outcome is the primary aim of salvage therapy, but many patients may be left with treatment-related adverse consequences, potentially affecting their quality of living. The aim of this review was to evaluate the rates and severity of various functional outcomes after salvage therapy in patients with radiation recurrent PCa. Local salvage therapies are associated with impaired urinary and sexual functions depending on the specific salvage strategy. However, accurate estimation of the likelihood of these sequalae may be predictable based on the high pre-salvage general and disease specific health status. Despite these adverse consequences and impaired quality of life, oncologic advantage of local salvage treatment post radiation recurrence prostate cancer seems justified in general, but shared decision working with an informed patient is essential. This paper serves as a discussion platform for this process.Purpose: To assess the rate and severity of functional outcomes after salvage therapy for radiation recurrent prostate cancer. Methods: This systematic review of the MEDLINE/PubMed database yielded 35 studies, evaluating salvage radical prostatectomy (RP), brachytherapy (BT), high-intensity focal ultrasound (HIFU) and cryotherapy (CT) after failure of primary radiation therapy. Data on pre- and post-salvage rates and severity of functional outcomes (urinary incontinence, erectile dysfunction, and lower urinary tract symptoms) were collected from each study. Results: The rates of severe urinary incontinence ranged from 28–88%, 4.5–42%, 0–6.5%, 2.4–8% post salvage RP, HIFU, CT and BT, respectively. The rates of erectile dysfunction were relatively high reaching as much as 90%, 94.6%, 100%, 62% following RP, HIFU, CT and BT, respectively. Nonetheless, the high pre-salvage rates of ED preclude accurate estimation of the effect of salvage therapy. There was an increase in the median IPSS following salvage HIFU, BT and CT ranging from 2.5–3.4, 3.5–12, and 2, respectively. Extended follow-up showed a return-to-baseline IPSS in a salvage BT study. The reported data suffer from selection, reporting, publication and period of study biases, making inter-study comparisons inappropriate. Conclusions: local salvage therapies for radiation recurrent PCa affect continence, lower urinary tract symptoms and sexual functions. The use of local salvage therapies may be warranted in the setting of local disease control, but each individual decision must be made with the informed patient in a shared decision working process.

Evaluation of functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) procedure in men with primary localized, non-metastatic prostate cancer: results from the HIFU Evaluation and Assessment of Treatment (HEAT) registry.

To assess change in functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) treatment compared with outcomes after one focal HIFU treatment. In this multicentre study (2005-2016), 821 men underwent focal HIFU for localized non-metastatic prostate cancer. The patient-reported outcome measures of International Prostate Symptom Score (IPSS), pad usage and erectile function (EF) score were prospectively collected for up to 3years. To be included in the study, completion of at least one follow-up questionnaire was required. The primary outcome was comparison of change in functional outcomes between baseline and follow-up after one focal HIFU procedure vs after a second focal HIFU procedure, using IPSS, Expanded Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF) questionnaires. Of 821 men, 654 underwent one focal HIFU procedure and 167 underwent a second focal HIFU procedure. A total of 355 (54.3%) men undergoing one focal HIFU procedure and 65 (38.9%) with a second focal HIFU procedure returned follow-up questionnaires, respectively. The mean age and prostate-specific antigen level were 66.4 and 65.6years, and 7.9 and 8.4ng/mL, respectively. After one focal HIFU treatment, the mean change in IPSS was -0.03 (P = 0.02) and in IIEF (EF score) it was -0.4 (P = 0.02) at 1-2years, with no subsequent decline. Absolute rates of erectile dysfunction increased from 9.9% to 20.8% (P = 0.08), leak-free continence decreased from 77.9% to 72.8% (P = 0.06) and pad-free continence from 98.6% to 94.8% (P = 0.07) at 1-2years, respectively. IPSS prior to second focal HIFU treatment compared to baseline IPSS prior to first focal HIFU treatment was lower by -1.3 (P = 0.02), but mean IPSS change was +1.4 at 1-2years (P = 0.03) and +1.2 at 2-3years (P = 0.003) after the second focal HIFU treatment. The mean change in EF score after the second focal HIFU treatment was -0.2 at 1-2years (P = 0.60) and -0.5 at 2-3years (P = 0.10), with 17.8% and 6.2% of men with new erectile dysfunction. The rate of new pad use was 1.8% at 1-2years and 2.6% at 2-3years. A second focal HIFU procedure causes minor detrimental effects on urinary function and EF. These data can be used to counsel patients with non-metastatic prostate cancer prior to considering HIFU therapy.

Does Dr Google give good advice about prostate cancer?

In this issue of BJUI, Rezaee et al. 1 report on Google trends as a barometer of public interest in PSA screening and different types of prostate cancer treatment in the USA. Not surprisingly, they found a decrease in Google searches about PSA screening after the US Preventive Services Task Force (USPSTF) issued a Grade D recommendation against screening. This corresponds with observed trends of decreased PSA screening in the population 2. Notably, the volume of Google searches about PSA screening rebounded after the USPSTF changed to a Grade C recommendation for shared decision-making about screening. It is unknown whether this actually reflects a greater number of men discussing PSA screening with their doctors, or whether online information had an impact on their decisions. Meanwhile, the quantity of Google search activity varied between different types of prostate cancer treatment. In the USA, search volume was higher for surgery than for active surveillance, and there was a greater search volume for high-intensity focused ultrasonography (HIFU) than for external beam radiation therapy or brachytherapy. Notably, another recent study examined global Google trends in searches on prostate cancer treatment, showing increasing annual relative search volume for focal therapy and active surveillance over time 3. The underlying reasons for these temporal and geographic differences in ‘public interest’ may be multi-factorial, including recommendations from physicians and professional societies, support from policy-makers, public awareness campaigns from healthcare-related organizations and marketing from commercial companies. Whether the change in ‘public interest’ had any impact on treatment selection remains unknown. As an increasing number of people are going online for health information, digital platforms provide useful barometers for public interest in different topics. For example, another recent study reported that prostate cancer was a topic with high public interest based on the number of video views on YouTube compared to other urological conditions 4. While interesting, the number of Google searches or views on YouTube do not provide any insights into who is searching for the information, their motivation, and the quality of information that they received. Concerningly, several recent studies have called into question the accuracy of information about prostate cancer across multiple online platforms. Asafu-Adjei et al. 5 reported that websites on HIFU and cryotherapy had a substantial amount of incomplete or inaccurate information. Alsyouf et al. 6 reported that seven of the 10 most commonly shared articles about prostate cancer on social media were inaccurate or misleading. Finally, our group reported that 77% of the first 150 YouTube videos about prostate cancer had potentially misinformative and/or biased content in the video itself or the comments underneath 7. Alarmingly, the quality of information was inversely correlated with the number of views. More research is needed to evaluate the impact of exposure to online misinformation on prostate cancer screening and treatment. Overall, the online environment holds great promise and also great peril in prostate cancer. On one hand, digital networks have opened up new opportunities for global scientific exchange and have the potential to greatly improve patient care. Conversely, there is a substantial amount of misinformation on the internet, and the potential for a negative impact on patients and their families. As a urological community, we should be pro-active about directing our patients to trustworthy online resources, and should actively participate in digital networks to help share high-quality information with the public. More strategic effort should also be made to maximize the degree of reach and engagement upon dissemination of high-quality information. Stacy Loeb is supported by the Prostate Cancer Foundation and the Edward Blank and Sharon Cosloy-Blank Family Foundation. Stacy Loeb reports reimbursed travel to the Prostate Cancer Foundation Retreat from Sanofi, consulting fees from Lilly, Lumenis and Bayer, and equity in Gilead.

Medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer.

To report medium-term oncological outcomes in men receiving primary focal treatment with high-intensity focused ultrasonography ( HIFU) for prostate cancer (PCa). Consecutive patients with PCa treated with primary focal HIFU at two centres by six treating clinicians were assessed. Patients were submitted to either focal ablation or hemi-ablation using HIFU (Sonablate 500). The primary objective of the study was to assess medium-term oncological outcomes, defined as overall survival, freedom from biopsy failure, freedom from any further treatment and freedom from radical treatment after focal HIFU. The secondary objective was to evaluate the changes in pathological features among patients treated with focal HIFU over time. We also assessed the relationship between year of surgery and 5-year retreatment probability. A total of 1032 men treated between November 2005 and October 2017 were assessed. The median age was 65 years and median prostate-specific antigen level was 7 ng/mL. The majority of patients had a Gleason score of 3 + 4 or above (80.3%). The median (interquartile range) follow-up was 36 (14-64) months. The overall survival rates at 24, 60 and 96 months were 99%, 97% and 97%, respectively. Freedom from biopsy failure, defined as absence of Gleason 3 + 4 disease, was 84%, 64% and 54% at 24, 60 and 96 months. Freedom from any further treatment was 85%, 59% and 46% at 24, 60 and 96 months, respectively. Approximately 70% of patients who were retreated received a second focal treatment. Freedom from radical treatment was 98%, 91% and 81% at 24, 60 and 96 months. During the study period, we observed an increase in the proportion of patients undergoing focal HIFU with Gleason 3 + 4 disease and with T2 stage disease as defined by multiparametric magnetic resonance imaging. Finally, there was a reduction over time in the proportion of patients undergoing re-treatment within 5 years of first treatment. Focal HIFU for PCa is a feasible therapeutic strategy, with acceptable survival and oncological results and a reduction in the 5-year retreatment rates over the last decade. Re-do focal treatment is a feasible technique whose functional and oncological outcomes have still to be evaluated.

Late toxicity described using patient reported outcomes measures (PROMS) in men treated with salvage radiation following primary high intensity focal ultrasound (HIFU) for localized prostate cancer.

131 Background: In primary treatment of localised prostate cancer, minimally invasive ablative therapies such as HIFU aim to achieve cancer control whilst offering a potentially favourable toxicity profile. At 5 years median follow up, 12% of patients treated with focal HIFU require salvage therapy. PROMS using Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC‐CP) provide a validated and clinically relevant tool to assess and quantify side effects from pelvic radiotherapy. There is limited data on late toxicity using PROMs with salvage radiotherapy in this setting. Methods: Retrospective analysis from prospectively collected data of 28 patients who received salvage radiotherapy at our institution 2010-2018 was performed. Late bowel and urinary toxicity measured by EPIC-CP is reported. Results: Gleason score at diagnosis: 3+3 4/28; 3+4 22/28; 4+3 2/28. HIFU treatment received: focal: 9/28; whole gland: 6/28; focal and redo focal: 7/28; focal and redo whole gland: 1/28; whole gland and redo: 5/28. All patients had mpMRI and biopsy proven recurrence with median PSA 6.6 ng/ml (0.57- 30.89). Median age at radiation was 67 years (55-80). Patients received 74 Gy to the prostate and 4 patients received additional pelvic lymph node irradiation. Three men received conformal radiotherapy (multiphase technique) and 25 arcing intensity modulated radiotherapy with hormone therapy as per risk stratification. Cumulative incidence of toxicity is reported at median follow-up of 43 months (7-99). Overall urinary function: no problem 8/28; very small problem 4/28; small problem 7/28; moderate problem 5/28; big problem 4/28 Urinary Incontinence Symptom Score: 2.5/12 (0-12) Urinary Irritation /Obstructive Symptom Score: 3.1/12 (0-12) Bowel Symptom Score: 3.5/12 (0-11) Biochemical relapse has occurred in 2/28 patients. Conclusions: Functional and oncological outcomes for a greater number of patients treated with minimally invasive ablative therapies followed by salvage radiation are required, however this data suggests radiation is a well-tolerated and effective salvage option following primary HIFU.

P042 Late toxicity in patients treated with salvage radical radiotherapy following primary High-Intensity Focal Ultrasound (HIFU) for localized prostate cancer

P042 Late toxicity in patients treated with salvage radical radiotherapy following primary High-Intensity Focal Ultrasound (HIFU) for localized prostate cancer

Image-guided robotic interventions for prostate cancer

Robotic prostatectomy is a common surgical treatment for men with prostate cancer, with some studies estimating that 80% of prostatectomies now performed in the USA are done so robotically. Despite the technical advantages offered by robotic systems, functional and oncological outcomes of prostatectomy can still be improved further. Alternative minimally invasive treatments that have also adopted robotic platforms include brachytherapy and high-intensity focused ultrasonography (HIFU). These techniques require real-time image guidance--such as ultrasonography or MRI--to be truly effective; issues with software compatibility as well as image registration and tracking currently limit such technologies. However, image-guided robotics is a fast-growing area of research that combines the improved ergonomics of robotic systems with the improved visualization of modern imaging modalities. Although the benefits of a real-time image-guided robotic system to improve the precision of surgical interventions are being realized, the clinical usefulness of many of these systems remains to be seen.

Focal ablation of prostate cancer

The aim of the article was to evaluate the treatment potential for focal therapies of prostate cancer (PCa). A literature research was performed to evaluate efficiency of the minimally invasive methods of PCa treatment. The two treatment methods evaluated were high-intensity focused ultrasonography (HIFU) and cryoablation. There are few studies with sufficient long-term follow-up and follow-up criteria are very diverse. The increasing number of cryoablation and HIFU treatments in the last 10 years confirms the considerable demand for minimally invasive treatment for localized PCa. Focal ablation of PCa is an interesting treatment option for low-risk PCa, but there are not many opportunities for this treatment and the patient experience is often negative.

Morbidity of Focal Therapy in the Treatment of Localized Prostate Cancer

BackgroundFocal therapy (FT) for prostate cancer (PCa) seems to be part of a natural evolution in the quest to improve the management of early organ-confined disease. ObjectiveTo assess the morbidity of the initial experience of FT in a tertiary referral center for PCa management. Design, setting, and participantsFrom 2009 to 2011, a total of 1213 patients with clinically localized PCa were treated at our institution. Of these patients, 547 were considered to have indolent disease according to the D’Amico criteria for low-risk disease plus unilateral disease with a maximum of three positive biopsies. A total of 106 patients underwent FT using high-intensity focused ultrasonography (HIFU), brachytherapy, cryotherapy, or vascular-targeted photodynamic therapy (VTP). Outcome measurements and statistical analysisComplications were prospectively recorded and graded according to the Clavien-Dindo scale. Data were prospectively collected and retrospectively analyzed. Results and limitationsThis study included 106 patients, median age 66.5 yr (interquartile range [IQR]): 61–73), who had a prostate hemiablation; 50 patients (47%) had cryotherapy, 23 patients (22%) had VTP, 21 patients (20%) received HIFU, and 12 patients (11%) had brachytherapy. The median prostate-specific antigen (PSA) level was 6.1 ng/ml (IQR: 5–8.1), all the patients had a biopsy Gleason score of 6, and the median prostate weight was 43g (IQR: 33–55). The median International Prostate Symptom Score was 6 (IQR: 3–10), and the median International Index of Erectile Function score was 20 (IQR: 15–23). After treatment, the median PSA at 3, 6, and 12 mo was 3.1 2.9, and 2.7 ng/ml (IQR: 2–5.1, 1.1–4.7, and 1–4.4), respectively. Thirteen percent of the patients experienced treatment-related complications. There were 11 minor medical complications (10 grade 1 complications and 1 grade 2 complication), 2 grade 3 complications, and no grade 4 or higher complications. ConclusionsFT for a highly selected population with PCa is feasible and had an acceptable morbidity with <2% major complications.

Safety and Tolerability of High-Intensity Focused Ultrasonography for Noninvasive Body Sculpting: 24-Week Data From a Randomized, Sham-Controlled Study

High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.

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

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. To assess 4-year biochemical failure (BCF) rates in patients after high-intensity focused ultrasonography (HIFU) treatment using the Horwitz and Stuttgart definitions. 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. 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 (Q(1):0, Q(3):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. 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.

Localized but Biochemicaly Progressing Prostate Cancer Under Long-Term Hormonal Ablation Treated by Therapeutic High-Intensity Focal Robotic Ultrasound

Treatment of hormone-refractory prostate cancer (HRPCa) is challenging and rewarding at the same time. Use of high-intensity focal ultrasound (HIFU) as primary prostate cancer therapy is still judged to be experimental, ignoring the fact that already more than 30.000 men worldwide have been treated and that 10 years data are available. Early onset of androgen deprivation therapy (ADT) and general longer patient survival lead to an increase in the number of patients requiring post-hormonal therapy resulting in increasing numbers of biochemical PSA relapse after few years.

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

• 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. • We performed a retrospective review of all patients in our centre who received first-line treatment with a second-generation Ablatherm™ 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. • 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. • In our experience, Ablatherm™ 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.

Eight Years' Experience With High-Intensity Focused Ultrasonography for Treatment of Localized Prostate Cancer

To report on the long-term results of high-intensity focused ultrasonography (HIFU) in the treatment of localized prostate cancer. Patients with clinical Stage T1-T2N0M0, biopsy-proven, localized prostate cancer, with a serum prostate-specific antigen (PSA) level of <or=20 ng/mL, Gleason score of <or=7, and with no previous curative prostate cancer treatment, were included. All patients underwent HIFU using the Ablatherm device and were required to have a minimal follow-up of 3 years after the last HIFU session to be included in this analysis. Follow-up included PSA measurement and biopsy performed 3-6 months after treatment and in conjunction with an increasing PSA level. Biochemical failure was defined according to the Phoenix definition (PSA nadir + 2 ng/mL). In determining the disease-free survival rate, treatment was considered to have failed if any of the following occurred: biochemical failure, positive biopsy findings, or the initiation of salvage treatment. The study included 163 patients. Within the 4.8 +/- 1.2 years of follow-up, no patient died of prostate cancer. Of the 163 patients, 86.4% achieved a PSA nadir of <1 ng/mL and 92.7% had negative post-treatment biopsy findings. The actuarial biochemical survival rate at 5 years was 75%. The actuarial disease-free survival rate at 5 years was 66%, with salvage treatment initiated for 12% of the patients. On multivariate analysis, the pretreatment PSA level was the only statistically significant predictive factor of recurrence (P = .005). The results after long-term follow-up have indicated that HIFU is an efficient and safe treatment for patients with localized prostate cancer.

Transcutaneous high-intensity focused ultrasonography can cure testicular cancer in solitary testis

Objectives To report the long-term results in 7 patients (including the 5-year results in 3 patients) after high-intensity focused ultrasonography (HIFU) combined with irradiation to treat testicular tumors in a solitary testis. Methods Transcutaneous HIFU ablation of testicular tumors is based on a technique using a piezoceramic transducer operating at 4.0 MHz with a site intensity of 1600 to 2000 W/cm 2. In a Phase II trial, 7 patients with the typical sonographic pattern of a tumor in a solitary testis were treated with transcutaneous HIFU, as a minimally invasive organ-preserving approach, followed 6 weeks later by prophylactic testicular irradiation (range 18 to 20 Gy). The aim was to ablate the entire cancer in a single therapeutic HIFU session. In all 7 patients, the contralateral testis had previously been removed because of testicular cancer. Results One patient received two cycles of chemotherapy for a single suspicious retroperitoneal lymph node diagnosed 6 months after HIFU. The other 6 protocol-treated patients remained tumor free at a mean follow-up of 42 months (range 3 to 93). One patient, who had refused postoperative irradiation, developed a recurrent tumor within 6 months. No patient showed any signs of clinical hypogonadism, and the International Index of Erectile Function score was normal for all patients. No androgen substitution was necessary. The only adverse effect noted was a small thermal lesion of the scrotum in 1 patient. Conclusions Despite the lack of tumor histologic examination, transcutaneous HIFU followed by irradiation permits a minimally invasive, organ-preserving, curative treatment for tumors in a solitary testis.

Local recurrence of prostate cancer after external beam radiotherapy: early experience of salvage therapy using high-intensity focused ultrasonography

Objectives To evaluate the efficacy and safety of a salvage therapy using transrectal high-intensity focused ultrasonography (HIFU) for locally recurrent prostate cancer after external beam radiotherapy. Methods All patients were treated with HIFU under general or spinal anesthesia. Specific parameters were progressively defined to avoid any rectal damage. Patient follow-up included sextant biopsy and prostate-specific antigen (PSA) measurement. Results A total of 71 patients were included in this series. The main baseline characteristics before HIFU were mean age 67 ± 5.86 years, mean prostate volume 21.4 ± 11.1 cm 3, and mean PSA level 7.73 ± 8.10 ng/mL. All biopsies were positive, with a pre-HIFU Gleason score of 2 to 6 in 24 patients, 7 in 13 patients, and 8 to 10 in 34 patients. The mean patient follow-up was 14.8 months (range 6 to 86). After HIFU treatment, 57 (80%) of the 71 patients had negative biopsies, and 43 (61%) of 71 had a nadir PSA level of less than 0.5 ng/mL. The nadir level was obtained within 3 months. At the last follow-up, 44% of the patients had no evidence of any disease progression. The adverse events related to HIFU included rectourethral fistula in 6%, grade 3 incontinence in 7%, and bladder neck stenosis in 17%. No rectal injury occurred with the use of specific parameters. Conclusions HIFU appears to be a promising treatment option with a curative chance for patients with local recurrence after external beam radiotherapy. The HIFU-related morbidity was lower than the morbidity reported after other types of salvage therapy, leading to a favorable risk/benefit ratio.