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Background: Focal therapy aims to treat areas of cancer to confer oncological control whilst reducing treatment-related functional detriment., Objective: To report oncological outcomes and adverse events following focal high-intensity focused ultrasound (HIFU) for treating nonmetastatic prostate cancer., Design, Setting, and Participants: An analysis of 1379 patients with ≥6 mo of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centres (2005-2020) was conducted. Five or more years of follow-up was available for 325 (24%) patients. Focal HIFU therapy used a transrectal ultrasound-guided device (Sonablate; Sonacare Inc., Charlotte, NC, USA)., Outcome Measurements and Statistical Analysis: Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer-specific mortality. Differences in FFS between D'Amico risk groups were determined using a log-rank analysis. Adverse events were reported using Clavien-Dindo classification., Results and Limitations: The median (interquartile range) age was 66 (60-71) yr and prostate-specific antigen was 6.9 (4.9-9.4) ng/ml with D'Amico intermediate risk in 65% (896/1379) and high risk in 28% (386/1379). The overall median follow-up was 32 (17-58) mo; for those with ≥5 yr of follow-up, it was 82 (72-94). A total of 252 patients had repeat focal treatment due to residual or recurrent cancer; overall 92 patients required salvage whole-gland treatment. Kaplan-Meier 7-yr FFS was 69% (64-74%). Seven-year FFS in intermediate- and high-risk cancers was 68% (95% confidence interval [CI] 62-75%) and 65% (95% CI 56-74%; p = 0.3). Clavien-Dindo >2 adverse events occurred in 0.5% (7/1379). The median 10-yr follow-up is lacking., Conclusions: Focal HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having, respectively, intermediate- and high-risk cancer, has good cancer control in the medium term., Patient Summary: Focal high-intensity focused ultrasound treatment to areas of prostate with cancer can provide an alternative to treating the whole prostate. This treatment modality has good medium-term cancer control over 7 yr, although 10-yr data are not yet available., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To study the feasibility of transvesical prostate resection and its effect on urethral stricture., Materials and Methods: We included 99 patients with symptomatic bladder outlet obstruction who underwent transvesical resection of prostate (TVRP; n = 48) and transurethral (TURP; n = 51) prostatectomy. We examined all the patients by means of digital rectal examination, transrectal ultrasound, and evaluated them by international prostate symptom score, quality of life score, uroflowmetric assessment and PSA level, and established definitive diagnosis. We followed up the patients in first month, third month, and the first year of the operation and monitored once a year in the following years., Results: In this study, totally 99 symptomatic bladder outlet obstruction patients were included (TVRP = 48 and TURP = 51). Mean age of the patients were 66.5 ± 8.2vs 68 ± 9.8years for our patients with TVRP and TURP, respectively. Two groups displayed similar values in terms of improvements in the Qmax and PVR, and there were no statistically significant differences in between. We obtained similar values for resection time and weight of resected prostate tissue in both groups. Urethral stricture was not observed in TVRP group. In TURP group however, stricture was observed in 4 (7.8%) patients in bulbar urethra in sixth month at average. And there was also a concomitant urethral meatal stricture in one of these patients. When the 2 groups were compared, the rate of urethral stricture was statistically significantly higher in the TURP group (P = .001)., Conclusion: Resection of prostate without using urethra significantly reduces the incidence of urethral stricture due to mucosal damage., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Clinically significant nonmetastatic prostate cancer (PCa) is currently treated using whole-gland therapy. This approach is effective but can have urinary, sexual, and rectal side effects., Objective: To report on 5-yr PCa control following focal high-intensity focused ultrasound (HIFU) therapy to treat individual areas of cancer within the prostate., Design, Setting, and Participants: This was a prospective study of 625 consecutive patients with nonmetastatic clinically significant PCa undergoing focal HIFU therapy (Sonablate) in secondary care centres between January 1, 2006 and December 31, 2015. A minimum of 6-mo follow-up was available for599 patients. Intermediate- or high-risk PCa was found in 505 patients (84%)., Intervention: Disease was localised using multiparametric magnetic resonance imaging (mpMRI) combined with targeted and systematic biopsies, or transperineal mapping biopsies. Areas of significant disease were treated. Follow-up included prostate-specific antigen (PSA) measurement, mpMRI, and biopsies., Outcome Measurements and Statistical Analysis: The primary endpoint, failure-free survival (FFS), was defined as freedom from radical or systemic therapy, metastases, and cancer-specific mortality., Results and Limitations: The median follow-up was 56 mo (interquartile range [IQR] 35-70). The median age was 65 yr (IQR 61-71) and median preoperative PSA was 7.2 ng/ml (IQR 5.2-10.0). FFS was 99% (95% confidence interval [CI] 98-100%) at 1 yr, 92% (95% CI 90-95%) at 3 yr, and 88% (95% 85-91%) at 5 yr. For the whole patient cohort, metastasis-free, cancer-specific, and overall survival at 5 yr was 98% (95% CI 97-99%), 100%, and 99% (95% CI 97-100%), respectively. Among patients who returned validated questionnaires, 241/247 (98%) achieved complete pad-free urinary continence and none required more than 1 pad/d. Limitations include the lack of long-term follow-up., Conclusions: Focal therapy for select patients with clinically significant nonmetastatic prostate cancer is effective in the medium term and has a low probability of side effects., Patient Summary: In this multicentre study of 625 patients undergoing focal therapy using high-intensity focused ultrasound (HIFU), failure-free survival, metastasis-free survival, cancer-specific survival, and overall survival were 88%, 98%, 100%, and 99%, respectively. Urinary incontinence (any pad use) was 2%. Focal HIFU therapy for patients with clinically significant prostate cancer that has not spread has a low probability of side effects and is effective at 5 yr., (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: To report our experience with salvage high-intensity focused ultrasound (HIFU) in patients with local failure after brachytherapy for prostate cancer., Patients and Methods: Whole-gland HIFU was administered to prospectively recruited patients with local histologic failure after brachytherapy at 2 institutions in the United Kingdom and Canada. Functional and oncologic outcomes of the procedure were analyzed., Results: Nineteen patients underwent the treatment, 12 with Gleason sum 7 and 5 with Gleason sum 8 at recurrence. Thirteen men had grade-3a or -3b complications by the Clavien system; there were no grade-4 or -5 complications. The most common postoperative complication was dysuria, which was self-limited. Three men developed rectourethral fistulae. The overall continence rate was 68.4%. At a mean follow-up of 51.6 months, all men were alive. The overall biochemical recurrence-free survival rate was 66.7% and 73.3% using the "nadir prostate-specific antigen level" +1.3 ng/mL and +2 mg/ml criteria, respectively. This study is limited by the small cohort size, relatively short follow-up period, and heterogeneity of the patient population., Conclusion: In this, the largest prospective series to date, we demonstrate that salvage HIFU for locally recurrent prostate cancer after failed primary brachytherapy has encouraging disease control results, albeit with a relatively high complication rate., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Context: The incidence of localised prostate cancer is increasing worldwide. In light of recent evidence, current, radical, whole-gland treatments for organ-confined disease have being questioned with respect to their side effects, cancer control, and cost. Focal therapy may be an effective alternative strategy., Objective: To systematically review the existing literature on baseline characteristics of the target population; preoperative evaluation to localise disease; and perioperative, functional, and disease control outcomes following focal therapy., Evidence Acquisition: Medline (through PubMed), Embase, Web of Science, and Cochrane Review databases were searched from inception to 31 October 2012. In addition, registered but not yet published trials were retrieved. Studies evaluating tissue-preserving therapies in men with biopsy-proven prostate cancer in the primary or salvage setting were included., Evidence Synthesis: A total of 2350 cases were treated to date across 30 studies. Most studies were retrospective with variable standards of reporting, although there was an increasing number of prospective registered trials. Focal therapy was mainly delivered to men with low and intermediate disease, although some high-risk cases were treated that had known, unilateral, significant cancer. In most of the cases, biopsy findings were correlated to specific preoperative imaging, such as multiparametric magnetic resonance imaging or Doppler ultrasound to determine eligibility. Follow-up varied between 0 and 11.1 yr. In treatment-naïve prostates, pad-free continence ranged from 95% to 100%, erectile function ranged from 54% to 100%, and absence of clinically significant cancer ranged from 83% to 100%. In focal salvage cases for radiotherapy failure, the same outcomes were achieved in 87.2-100%, 29-40%, and 92% of cases, respectively. Biochemical disease-free survival was reported using a number of definitions that were not validated in the focal-therapy setting., Conclusions: Our systematic review highlights that, when focal therapy is delivered with intention to treat, the perioperative, functional, and disease control outcomes are encouraging within a short- to medium-term follow-up. Focal therapy is a strategy by which the overtreatment burden of the current prostate cancer pathway could be reduced, but robust comparative effectiveness studies are now required., (Copyright © 2013 European Association of Urology. All rights reserved.)

Objective: To investigate whether altered prostate specific antigen (PSA) levels due to individual prostate growth may affect the PSA velocity (PSAV)., Materials and Methods: Between January 2000 and December 2009, a total of 159 men with at least 2 transrectal ultrasonography (TRUS) procedures and concurrent PSA measurements underwent prostate biopsy because of suspicion of prostate cancer. We measured PSAV, prostate volume velocity (PVV), PSA density (PSAD), PSAD velocity (PSADV), and PSAV per initial volume. We then classified the total group into a prostate cancer (PC) group and non-PC group, and compared the 2 groups. We investigated which variables were exact to predict prostate biopsy using univariate and multivariate analyses, and assessed the diagnostic performance using the receiver operating characteristic (ROC) curve., Results: PVV showed a positive correlation with initial prostate volume in the total and non-PC group; PVV showed a positive correlation with PSAV, and initial prostate volume correlated with PSAV in the non-PC group. The PC group showed smaller prostate volumes, higher PSAD, higher PSADV, higher PSAV per initial volume, and longer follow-up periods. After adjusting for confounding factors, the odds ratios of prostate cancer across the quartile of PSAVD were 1, 1.889, 3.226, and 7.125 (P for trend = .007), and PSAV per initial volume were 1, 2.924, 2.937, and 7.536 (P for trend = .031). On the ROC curve, the areas under the curves (AUC) of PSAV per initial volume were higher than for PSAV and PSADV., Conclusion: Altered PSA levels due to individual prostate growth may affect the use of PSAV to predict prostate biopsy outcomes in follow-up., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objectives: To determine whether combining short-term neoadjuvant androgen deprivation therapy (NADT) with high-intensity focused ultrasound (HIFU) had a significant benefit in a large population of men with nonmetastatic prostate cancer (CaP)., Methods: We evaluated the records of 530 patients whose prostate-specific antigen (PSA) level at diagnosis was 30 ng/mL or less and whose follow-up period was not less than 12 months, at seven investigational sites. Two hundred seventy patients had received NADT (within 6 months), and 260 had not. The primary outcome measure was disease-free survival according to the combined criteria satisfying the Phoenix definition (less than nadir + 2), negative prostate biopsy, and no findings of distant metastasis after the last HIFU treatment. The significance of the differences of values or the distributions of each parameter between two groups was evaluated with a Mann-Whitney U test, unpaired t test, or chi-square test, and a multivariate Cox proportional hazards model was used to evaluate the prognostic relevance of preoperative parameters., Results: Statistical analyses showed that the NADT group had worse disease (higher PSA and risk group) than the HIFU-only group. Variables shown by multivariate analyses to be significant prognostic parameters were pretreatment PSA level, clinical stage, and no use of NADT. Short-term NADT significantly improved the 3-year disease-free survival rate of patients with intermediate-risk and high-risk CaP. During follow-up the frequencies of complications did not differ significantly with or without NADT., Conclusions: Our retrospective study suggests that combining short-term NADT with HIFU treatment is of significant clinical benefit to intermediate-risk and high-risk CaP patients without increasing the likelihood of complications.

Objectives: To evaluate the first results of salvage radiotherapy after high-intensity focused ultrasound (HIFU) in terms of feasibility, tolerance, and oncologic control., Methods: From March 1995 to May 2004, 45 patients presenting with local failure after HIFU underwent salvage radiotherapy alone (n = 32) or combined with hormonal therapy (n = 13). The modalities of radiotherapy are described. Tolerance was evaluated using the Radiation Therapy Oncology Group score for urinary and digestive side effects, and incontinence was evaluated using the Ingelman Sundberg score. Patients answered a questionnaire. For the 32 patients who underwent radiotherapy alone, the oncologic early results were given by the disease-free survival rate, defined as no biochemical progression and no androgen suppression therapy., Results: The median and mean follow-up were 40 and 46 months, respectively, for the whole series. No additional digestive or urinary toxicity developed with salvage radiotherapy after HIFU. The data from 32 patients were evaluated, with a median follow-up of 37 months after radiotherapy. The 5-year disease-free survival rate was 64% for the 32 patients evaluated. The 5-year disease-free survival rate reached 80% for patients treated for positive biopsy findings and was 44% for those with isolated biochemical failure., Conclusions: Salvage radiotherapy after HIFU for local recurrence is feasible, with no additional toxicity. The early oncologic results are encouraging when isolated local recurrence is proven but longer follow-up is needed.

Objectives: To report on the long-term results of high-intensity focused ultrasonography (HIFU) in the treatment of localized prostate cancer., Methods: Patients with clinical Stage T1-T2N0M0, biopsy-proven, localized prostate cancer, with a serum prostate-specific antigen (PSA) level of

Objectives: Symptoms of benign prostatic hyperplasia affect men increasingly as they age. Minimally invasive therapies for the treatment of benign prostatic hyperplasia continue to evolve. We describe histotripsy, a noninvasive, nonthermal, focused ultrasound technology for precise tissue ablation, and report the initial results of using histotripsy for prostatic tissue ablation in an in vivo canine model., Methods: An annular 18-element, 750-kHz, phased-array ultrasound system delivered high-intensity (22 kW/cm(2)), ultrasound pulses (15 cycles in 20 ms) at pulse repetition frequencies of 100 to 500 Hz to canine prostates. Eight lateral lobe and nine periurethral treatments were performed in 11 anesthetized dogs. Diagnostic ultrasound transducers provided in-line and transrectal imaging. Retrograde urethrography was performed before and after the periurethral treatments. After treatment, the prostates were grossly examined, sectioned, and submitted for histologic examination., Results: In the lateral lobe treatments, a well-demarcated cavity containing liquefied material was present at the ablation site. Microscopically, the targeted volume was characterized by the presence of histotripsy paste (debris, absent cellular structures). A narrow margin of cellular injury was noted, beyond which no tissue damage was apparent. The periurethral treatments resulted in total urethral ablation or significant urethral wall damage, with visible prostatic urethral defects on retrograde urethrography. Real-time ultrasound imaging demonstrated a dynamic hyperechoic zone at the focus, indicative of cavitation and suggesting effective tissue ablation., Conclusions: The results of our study have shown that histotripsy is capable of precise prostatic tissue destruction and results in subcellular fractionation of prostate parenchyma. Histotripsy can also produce prostatic urethral damage and thereby facilitate drainage of finely fractionated material per urethra, producing immediate debulking.

Objectives: To assess if prostate-specific antigen (PSA) nadir is an independent predictor of treatment failure and disease-free survival after high-intensity focussed ultrasound (HIFU) therapy for localised prostate cancer as defined by the new ASTRO criteria., Methods: One hundred three patients after HIFU treatment (Ablatherm, EDAP, Lyon, France) for localised prostate cancer without previous hormonal therapy were evaluated retrospectively. Patients attended regular follow-up visits every 3 mo. Treatment failure was defined by the revised ASTRO criteria (PSA >or=2 ng/ml above nadir PSA, positive biopsy, if salvage treatment was administered). Patients were divided into three PSA nadir subgroups (group 1, 1 ng/ml). The disease-free survival rate (DFSR) was calculated by using life table methods. The log-rank test was used to compare the curves based on Kaplan-Meier models., Results: The median follow-up was 4.9 (3-8.6) yr. Mean time to PSA nadir was 6.4+/-5.1 mo. A PSA nadir of 1ng/ml was reached by 64%, 22.3%, and 13.6% of patients, respectively. Treatment failure rates during follow-up were 4.5%, 30.4%, and 100%, respectively, for the three groups (p<0.001). The actuarial DFSRs at 5 yr were 95%, 55%, and 0%, respectively, for the 3 groups (p<0.001)., Conclusions: The PSA nadir after HIFU correlates highly significantly with treatment failure and DFSR, and can be applied in daily clinical practice. Promising oncological outcome is obtained if a PSA nadir of

Objectives: To evaluate the current status of high-intensity focused ultrasound (HIFU) and cryosurgery as the primary treatment option in patients with prostate cancer., Method: A MedLine search using specified search terms was done on February 28, 2005. This search rendered 150 papers related to HIFU and 566 papers related to cryosurgery. Very few of these papers presented original outcome data and are included in the present review., Results: No controlled trial was available for analysis, and no survival data were presented. No validated biochemical, surrogate end point was available for any of the two therapies. HIFU showed progression-free survival (based on prostate-specific antigen+/-biopsy data) of 63-87% (projected 3- to 5-yr data), but median follow-up in the studies ranged from 12-24 mo. Negative postoperative biopsies was seen in 82-94% of patients. Complications have been reduced by the combination of transurethral resection of the prostate and HIFU. Cryosurgery showed a progression-free survival of 36-92% (projected 1-7 yr data), depending on risk groups and definition of failure. Negative biopsies were seen in 72-87%, but no biopsy data were available for the currently used third-generation cryotherapy machines. Complications seem to be lower with the third-generation machines., Conclusions: None of the evaluated therapies has enough data available to support their use as an alternative to established therapies (surgery, radiation) for localised prostate cancer. Until further data become available, the use of both treatments should be restricted to patients unfit for established therapies who still have the need for local therapy.

Objective: Transrectal ultrasound cannot accurately depict early cancer recurrences after prostate high-intensity focused ultrasound (HIFU) ablation. We evaluated transrectal color Doppler (CD) in guiding post-HIFU prostate biopsy., Methods: Prostate CD-guided sextant biopsies were obtained in 82 patients who had undergone prostate HIFU ablation for cancer, 24 of whom had hormone therapy before the treatment. At the time of biopsy, a subjective CD score was given to all biopsy sites (0=no flow; 1=minimal flow; 2=suspicious flow pattern). CD findings were compared with biopsy results., Results: CD was a significant predictor of biopsy findings, according to univariate and multivariate site-by-site analysis. However, only 36 of 94 sites with residual cancer had positive CD findings, and thus, negative CD findings should not preclude random biopsy. There was a significant interaction between CD diagnostic capability and a history of hormone therapy before HIFU treatment. CD was a significant and independent predictor of biopsy findings in patients who had not received hormone therapy (odds ratio: 4.4; 95%CI: 2.5-7.9; p<0.0001), but not in those who had (odds ratio: 1.3; 95%CI: 0.5-3.4; p>0.5)., Conclusion: Biopsy taken in CD-positive sites were 4.4 times more likely to contain cancer in patients who did not receive hormone therapy. CD could not reliably depict cancer recurrence in patients with history of hormone therapy.

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.

Objectives: To report on our 5-year results with transrectal high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. HIFU delivers high energy, causing rapid coagulation necrosis of tissue within the target area without damaging the surrounding tissue., Methods: A total of 146 patients with biopsy-proven Stage T1-T2N0M0 prostate cancer have been treated using the Ablatherm device. All patients had a prostate-specific antigen (PSA) level of 15 ng/mL or less and a Gleason score of 7 or less (inclusion criteria). The mean follow-up was 22.5 months (range 4 to 62) and included PSA measurement and control sextant biopsies., Results: The median PSA nadir 3 months after treatment was 0.07 ng/mL (range 0 to 5.67). The median PSA level after a follow-up of 22 months was 0.15 ng/mL (range 0 to 12.11), and 87% of the patients had a constant PSA level of less than 1 ng/mL; 93.4% of all patients had negative control biopsies. One rectourethral fistula was noted after a second HIFU treatment in a patient with a history of hemicolectomy and repetitive anal fistulas. Of all the patients, 12% underwent transurethral resection after HIFU because of obstruction, but no severe stress incontinence (grade 2 to 3) was observed. Erectile function was preserved in 47.3% of patients, and the International Prostate Symptom Score and Quality of Life Index did not change from before to after treatment., Conclusions: Our results demonstrated the efficacy and low-associated morbidity of HIFU. HIFU does not exclude other treatment options and is repeatable. HIFU seems to be a valid alternative treatment for patients who are not suitable for radical surgery.