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Objective: To establish a consensus on the utility of multiparametric magnetic resonance imaging (mpMRI) to identify patients for focal therapy., Methods: Urological surgeons, radiologists, and basic researchers, from Europe and North America participated in a consensus meeting about the use of mpMRI in focal therapy of prostate cancer. The consensus process was face-to-face and specific clinical issues were raised and discussed with agreement sought when possible. All participants are listed among the authors. Topics specifically did not include staging of prostate cancer, but rather identifying the optimal requirements for performing MRI, and the current status of optimally performed mpMRI to (i) determine focality of prostate cancer (e.g. localising small target lesions of ≥0.5 mL), (ii) to monitor and assess the outcome of focal ablation therapies, and (iii) to identify the diagnostic advantages of new MRI methods. In addition, the need for transperineal template saturation biopsies in selecting patients for focal therapy was discussed, if a high quality mpMRI is available. In other words, can mpMRI replace the role of transperineal saturation biopsies in patient selection for focal therapy?, Results: Consensus was reached on most key aspects of the meeting; however, on definition of the optimal requirements for mpMRI, there was one dissenting voice. mpMRI is the optimum approach to achieve the objectives needed for focal therapy, if made on a high quality machine (3T with/without endorectal coil or 1.5T with endorectal coil) and judged by an experienced radiologist. Structured and standardised reporting of prostate MRI is paramount. State of the art mpMRI is capable of localising small tumours for focal therapy. State of the art mpMRI is the technique of choice for follow-up of focal ablation., Conclusions: The present evidence for MRI in focal therapy is limited. mpMRI is not accurate enough to consistently grade tumour aggressiveness. Template-guided saturation biopsies are no longer necessary when a high quality state of the art mpMRI is available; however, suspicious lesions should always be confirmed by (targeted) biopsy., (© 2013 The Authors. BJU International © 2013 BJU International.)

Unlabelled: Study Type--Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? High-intensity focused ultrasound (HIFU) therapy has been proposed for the treatment of localized prostate cancer (PCa) for all risk levels of tumour recurrence. The study adds data on the efficacy of a single HIFU application in the treatment of PCa with different risks of recurrence. Durable cancer control was achieved in 81.7% of patients with low-risk disease, with rates of efficacy declining in intermediate- and high-risk tumours. The data suggest that the principal domain for minimal invasive HIFU should be low-risk disease., Objective: • To report cancer control results after a single application of high-intensity focused ultrasonography (HIFU) in patients with localized prostate cancer (PCa), stratified by tumour recurrence risk according to D'Amico risk classification., Patients and Methods: • In a retrospective single-centre study, we analysed the outcomes of patients with localized PCa who were treated with curative intent between December 2002 and October 2006 using an Ablatherm HIFU device (EDAP-TMS, France). • Transurethral resection of the prostate or adenomectomy were performed before HIFU to downsize large prostate glands. • Oncological failure was determined by the occurrence of biochemical relapse, positive biopsy and/or metastasis. Biochemical relapse was defined as a PSA nadir +1.2 ng/mL (Stuttgart definition), or as a rise in PSA level to ≥ 0.5 ng/mL if PSA doubling time was ≤ 6 months. Kaplan-Meier analysis was performed for survival estimates., Results: • A total of 191 consecutive patients were included in the study. The median (range) patient age was 69.7 (51-82) years, and 38, 34 and 28% of these patients were in the low-, intermediate- and high-risk groups, respectively. • The median (range) follow-up was 52.8 (0.2-79.8) months. • At 5 years, overall and cancer-specific survival rates were 86.3% and 98.4%, respectively. • Stratified by risk group, negative biopsy rates were 84.2%, 63.6%, and 67.5% (P = 0.032), 5-year biochemical-free survival rates were 84.8%, 64.9% and 54.9% (P< 0.01), and 5-year disease-free survival rates were 81.7%, 53.2% and 51.2% (P < 0.01), respectively., Conclusion: • Single-session HIFU is recommended as a curative approach in elderly patients with low-risk PCa. Patients at higher risk of tumour progression should be counselled regarding the likely need for salvage therapy, including repeat HIFU., (© 2012 BJU INTERNATIONAL.)

Unlabelled: What's known on the subject? and What does the study add? Novel therapeutic methods have emerged in recent years as 'focal' treatment alternatives in which cancer foci can be eradicated and greatly reducing the associated side-effects of radical treatment. High-intensity focused ultrasound (HIFU) seems to result in a well fitted technology, which has proven short- to medium-term cancer control, with a low rate of complications comparable with those of established therapies. This is an up-to-date review of the available literature on HIFU as a definitive treatment of prostate cancer. It describes the technique in a comprehensive approach in terms of technical features, procedure, indications, and gives an overview of its historical background; finally, we present the future applications of HIFU and its development trend., Objectives: • To provide an up-to-date review of the available literature on high-intensity focused ultrasound (HIFU) as a definitive treatment of prostate cancer. • To present the technique in a comprehensive approach, comparing the available devices according to the existing evidence in terms of technical features, procedure, indications, and to give an overview of its historical background; and finally, to discuss future applications of HIFU and its development trend., Materials and Methods: • A systematic literature search was conducted using MEDLINE and EMBASE via Ovid databases (January 2000 to December 2011), to identify studies on HIFU for treatment of prostate cancer. • Only English-language and human-based full manuscripts that reported on case series studies with >50 participants, patient characteristics, efficacy and safety data were included., Results: • No randomised controlled trials were identified by the literature search. We identified 31 uncontrolled studies that examined the efficacy of HIFU as primary treatment and two studies that examined the efficacy of HIFU as salvage treatment. • Most treated patients had localised prostate cancer (stage T1-T2); Gleason scores of 2-10 and mean prostate specific antigen (PSA) values of 4.6-12.7 ng/mL. The mean age range of the patients was 64.1-72 years. The mean follow-up ranged from 6.4 to 76.8 months. Negative biopsy rates ranged from 35 to 95%. PSA nadirs ranged from 0.04 to 1.8 ng/mL. The 5-year disease-free survival rates ranged from 61.2 to 95%; 7- and 8-year disease free survival rates ranged from 69 to 84%. • The most common complications associated with the HIFU procedure as the primary treatment included: urinary retention (<1-20%); urinary tract infections (1.8-47.9%); stress or urinary incontinence (<1-34.3%); and erectile dysfunction (20-81.6%). • Recto-urethral fistula was reported in <2% of patients. • Treatment-related morbidity appeared to be reduced by the combination of transurethral resection (TURP) of the prostate and HIFU., Conclusions: • Novel therapeutic methods have emerged in recent years as 'focal' treatment alternatives, in which cancer foci could be eradicated by greatly reducing the associated side-effects of radical treatment. • HIFU seems to result in short- to medium-term cancer control, with a low rate of complications comparable with those of established therapies. • However, longer-term follow-up studies are needed to evaluate cancer-specific and overall survival. If available promising results on HIFU for definitive treatment of prostate cancer are confirmed in future prospective trials, focal therapy could start to challenge the current standard of care., (© 2012 BJU INTERNATIONAL.)

What's known on the subject? and What does the study add? Focal therapy techniques are emerging in prostate cancer treatment. However, several key questions about patient selection, treatment and monitoring still have to be addressed. The concept of focal therapy is barely discussed in current urological guidelines. In the present manuscript, we report the results of a consensus meeting focused on ultrasonography, the most common used urological imaging method, in relation to focal therapy of prostate cancer. • To establish a consensus on the utility of ultrasonography (US) to select patients for focal therapy. Topics were the current status of US to determine focality of prostate cancer, to monitor and assess outcome of focal therapy and the diagnostic advantages of new US methods. In addition, the biopsy techniques required to identify focal lesions were discussed. • Urological surgeons, radiation oncologists, radiologists, and basic researchers from Europe and North America participated in a consensus meeting on the use of transrectal US (TRUS) in focal therapy of prostate cancer. The consensus process was face-to-face and specific clinical issues were raised and discussed with agreement sought when possible. • TRUS is commonly used and essential for diagnosing men with prostate cancer. It is particularly useful for targeting specific anatomical regions or visible lesions. However, it has several limitations and there is a need for improvement. Newer visualisation techniques, e.g. colour Doppler US, contrast-enhanced US and elastography, are being developed but currently there is no US technique that can accurately characterise a cancer suitable for focal therapy. Systematic biopsy is the only known procedure that allows the identification of prostate cancers suitable for focal therapy. Scarce data exist about the role of US for monitoring patients during or after ablative therapy. • Consensus was reached on all key aspects of the meeting. • US cannot reliably identify focal prostate cancer. New US methods show promising results in identifying prostate cancer focality. • Currently selecting appropriate candidates for focal therapy should be performed using dedicated protocols and biopsy schemes., (© 2012 THE AUTHORS. BJU INTERNATIONAL © 2012 BJU INTERNATIONAL.)

Unlabelled: 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., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

Objectives: • To assess the rationale, efficacy, and morbidity of various methods of achieving focal prostatic ablation. • To determine the current role of focal therapy in the management of localized prostate cancer., Methods: • We performed a literature review of focal therapy in prostate cancer, with an emphasis on more established methods such as cryoablation and high-intensity focused ultrasound., Results and Conclusions: • Focal ablative methods allow targeted destruction of prostatic tissue while limiting the morbidity associated with whole-gland therapy. • Local cancer control after focal therapy appears promising but does not approach that of established whole-gland therapies. • Until we have the ability to identify patients reliably with truly focal disease and predict their natural history, focal therapy cannot be considered to be the definitive therapy for localized prostate cancer., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

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.

Objective: To assess the totality of prostate cancer eradication in radical prostatectomy (RP) specimens from men with a unilaterally positive prostate biopsy, and who would currently qualify for subtotal prostate ablation with controlled thermal energy such as cryoablation or high-intensity focused ultrasound., Materials and Methods: Therapies for prostate cancer hold the promise of individualized treatment that selectively ablates the tumour while minimizing treatment-associated morbidity, but as prostate cancer is multifocal there are concerns about untreated residual disease. RP specimens (180) from men with a unilaterally positive prostate biopsy were examined to characterize the location, volume and grade of each tumour focus. Two treatment templates (hemiprostate and 'hockey-stick') were applied to every prostate cross-section. The nature of the in-field and out-of-field tumours was assessed and described for each treatment template., Results: A single focus of cancer was the only tumour in 31 (17%) of the patients (contralateral cancer was present in 149, 83%, of specimens despite a unilateral positive biopsy). Hemiprostate and hockey-stick treatment templates covered all tumour foci in 17% and 47% of men, respectively. Most out-of-field cancers were clinically insignificant tumours not identified by prostate biopsy (low-volume, 0.5 mL; and low grade, Gleason score < or =6). Regional ablation would have successfully treated all clinically significant prostate tumours in 64% and 81% of patients using the hemiprostate or hockey-stick template, respectively. The hockey-stick template encompassed all dominant tumours (largest volume)., Conclusions: Regionally targeted prostate ablation is capable of eradicating all dominant tumours and the vast majority of clinically significant tumours in men with unilateral disease by biopsy. The study of focally ablative therapy should proceed under the auspices of an approved protocol.

Objective: To compare the incidence of infective events between a single dose and 3-day antibiotic prophylaxis for transrectal ultrasonography (TRUS)-guided prostate biopsy., Patients and Methods: Patients were randomized to receive either one preoperative dose consisting of two ciprofloxacin 500 mg tablets 2 h before prostate biopsy, or 3 days of ciprofloxacin treatment. They had a clinical examination at study inclusion, the day of the biopsy and 3 weeks later. The day after the procedure all patients were contacted by telephone to inquire about any significant event. Biological testing and urine cultures were conducted 5 days before and then 5 and 15 days after the biopsy; a self-administered symptom questionnaire was completed by the patient 5 days before and then at 5 and 15 days., Results: The study group included 288 men, of whom 139 were randomized to the single-dose arm and 149 to the 3-day arm. Six patients in each group had an asymptomatic bacteriuria with no leukocyturia. One patient in each group had documented prostatitis, with Escherichia coli identified on urine culture. The strain identified in the patient from the 3-day group was resistant to ciprofloxacin. There was no difference between groups in symptoms at 5 and 21 days after biopsy., Conclusions: Current TRUS-guided prostate biopsy techniques lead to very few clinical infectious complications when accompanied by antibiotic prophylaxis. We found no argument to advocate the use of more than one dose of antibiotic prophylaxis.

Objective: To assess the role of magnetic resonance imaging (MRI) for evaluating changes in the prostate after transrectal high-intensity focused ultrasound (HIFU) for treating prostate cancer, correlating the findings with histology to assess its possible role in predicting the outcome, evaluating residual cancer or local recurrence of disease., Patients and Methods: Ten patients with prostate cancer were assessed with MR and MR spectroscopy (MRS) before and at 1, 4 and 12 months after HIFU, assessing the glandular volume and MRI and MRS data after HIFU. These data were correlated with the prostate-specific antigen (PSA) levels at each examination (suspicious for residual cancer if >0.5 ng/mL) and with histological findings of prostate biopsy sampling at 6-8 months (random or targeted at suspicious MR areas)., Results: Variations in volume during the follow-up were not associated with treatment outcome. MRI was suspicious for residual cancer in one patient at 1 month and in another two at 4 months; in all three patients (one with a PSA level of <0.5 ng/mL) targeted biopsies were positive for cancer. MRI was negative in seven patients; in six of these (one with a PSA level of >0.5 ng/mL) random biopsies were negative, and in one the random biopsies were positive for residual cancer. At 4 months there was a statistically significant difference (P = 0.015) between patients responsive to treatment and those with persistent disease, by combining negative MRI with a PSA level of <0.5 ng/mL; MRS data were suitable for analysis only in three patients with partial necrosis., Conclusion: Our preliminary data support the role of MRI in association with PSA levels as a useful and accurate tool in the follow-up of patients treated with HIFU for prostate cancer. However, considering the economic issue, it should not be used routinely and should be limited to detecting residual cancer (in patients with a PSA level of >0.5 ng/mL) with the main purpose of improving the detection rate of transrectal ultrasonography (TRUS)-guided prostate biopsy. MRS data had no additional value over MRI. Further evaluation is needed to compare the use of contrast media and other techniques (e.g. colour Doppler TRUS) in detecting residual or local recurrent cancer.

Objective: To explore the association between the prostate-specific antigen (PSA) nadir after transrectal high-intensity focused ultrasound (HIFU) therapy for organ-confined prostate cancer and subsequent treatment failure, as defined by the presence of residual disease at biopsy 6 months after treatment., Patients and Methods: Between January 1999 and January 2005, 115 patients in a Japanese hospital were treated using a transrectal HIFU system (Sonablate, Focus Surgery, IN, USA) for presumed localized adenocarcinoma of the prostate. All treatments were primary and none of the patients had received hormone therapy. The PSA level was measured at 2-monthly intervals and all patients had a transrectal prostate biopsy taken at 6 months. Multiple logistic regression was used to examine the relationship between PSA nadir and treatment failure, as defined by the presence of disease at biopsy., Results: The PSA nadir was strongly associated with treatment failure (P < 0.001). Patients with a PSA nadir of 0.0-0.2 ng/mL had a treatment failure rate of only 11% (four of 36), compared to 46% (17 of 37) in patients with a PSA nadir of 0.21-1.00 ng/mL and 48% (20 of 42) with a PSA nadir of >1.0 ng/mL. In addition, the PSA nadir was strongly associated with both preoperative PSA level and residual prostate volume., Conclusion: There is a clear and intuitive association between the PSA nadir and the risk of treatment failure after HIFU. These data can be used to predict the risk of residual disease in patients with prostate cancer undergoing HIFU therapy. They can also be used to inform where the target PSA nadir should be set for this novel therapy.

Objective: To prospectively compare the efficacy of bi-basal vs bi-apical periprostatic nerve block (PPNB) during 12-core prostate biopsy guided by transrectal ultrasonography (TRUS), and to evaluate the pain experienced on inserting the probe compared to the biopsy procedure, as PPNB with lignocaine local anaesthesia has been used for over a decade for minimizing pain during prostatic biopsy., Patients and Methods: In all, 143 men who were to have a TRUS-guided prostate biopsy were systematically randomized to two groups, to receive PPNB at the apex or base. A 10-cm visual analogue score was used to record the pain experienced during probe insertion, the biopsy and just before to leaving the department ., Results: The mean pain score on biopsy in the apical group was similar to that of the basal group (apex 1.9, base 1.6, P = 0.36). Probe introduction produced a significantly higher pain score (probe 2.2, biopsy 1.7, P < 0.001) than at the biopsy., Conclusions: Patients who experienced greater pain with the introduction of the probe also reported more pain with the biopsy procedure. The site of local anaesthetic before prostatic biopsy showed no significant difference in pain scores. Older men tolerated the procedure better. Analgesia after PPNB at near either the apex or base appears equal, regardless of the site of injection. We suggest that topical perianal anaesthetic agents could significantly reduce not only pain perception, but also improve tolerance.

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.