PRECISE Version 2: Updated Recommendations for Reporting Prostate Magnetic Resonance Imaging in Patients on Active Surveillance for Prostate Cancer.

BACKGROUND AND OBJECTIVE: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations standardise the reporting of prostate magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer. An international consensus group recently updated these recommendations and identified the areas of uncertainty. METHODS: A panel of 38 experts used the formal RAND/UCLA Appropriateness Method consensus methodology. Panellists scored 193 statements using a 1-9 agreement scale, where 9 means full agreement. A summary of agreement, uncertainty, or disagreement (derived from the group median score) and consensus (determined using the Interpercentile Range Adjusted for Symmetry method) was calculated for each statement and presented for discussion before individual rescoring. KEY FINDINGS AND LIMITATIONS: Participants agreed that MRI scans must meet a minimum image quality standard (median 9) or be given a score of 'X' for insufficient quality. The current scan should be compared with both baseline and previous scans (median 9), with the PRECISE score being the maximum from any lesion (median 8). PRECISE 3 (stable MRI) was subdivided into 3-V (visible) and 3-NonV (nonvisible) disease (median 9). Prostate Imaging Reporting and Data System/Likert ≥3 lesions should be measured on T2-weighted imaging, using other sequences to aid in the identification (median 8), and whenever possible, reported pictorially (diagrams, screenshots, or contours; median 9). There was no consensus on how to measure tumour size. More research is needed to determine a significant size increase (median 9). PRECISE 5 was clarified as progression to stage ≥T3a (median 9). CONCLUSIONS AND CLINICAL IMPLICATIONS: The updated PRECISE recommendations reflect expert consensus opinion on minimal standards and reporting criteria for prostate MRI in AS. PATIENT SUMMARY: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations are used in clinical practice and research to guide the interpretation and reporting of magnetic resonance imaging for patients on active surveillance for prostate cancer. An international panel has updated these recommendations, clarified the areas of uncertainty, and highlighted the areas for further research.

Picture Perfect: The Status of Image Quality in Prostate MRI.

Magnetic resonance imaging is the gold standard imaging modality for the diagnosis of prostate cancer (PCa). Image quality is a fundamental prerequisite for the ability to detect clinically significant disease. In this critical review, we separate the issue of image quality into quality improvement and quality assessment. Beginning with the evolution of technical recommendations for scan acquisition, we investigate the role of patient preparation, scanner factors, and more advanced sequences, including those featuring Artificial Intelligence (AI), in determining image quality. As means of quality appraisal, the published literature on scoring systems (including the Prostate Imaging Quality score), is evaluated. Finally, the application of AI and teaching courses as ways to facilitate quality assessment are discussed, encouraging the implementation of future image quality initiatives along the PCa diagnostic and monitoring pathway. EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 3.

Global Variation in Magnetic Resonance Imaging Quality of the Prostate.

Background High variability in prostate MRI quality might reduce accuracy in prostate cancer detection. Purpose To prospectively evaluate the quality of MRI scanners taking part in the quality control phase of the global PRIME (Prostate Imaging Using MRI ± Contrast Enhancement) trial using the Prostate Imaging Quality (PI-QUAL) standardized scoring system, give recommendations on how to improve the MRI protocols, and establish whether MRI quality could be improved by these recommendations. Materials and Methods In the prospective clinical trial (PRIME), for each scanner, centers performing prostate MRI submitted five consecutive studies and the MRI protocols (phase I). Submitted data were evaluated in consensus by two expert genitourinary radiologists using the PI-QUAL scoring system that evaluates MRI diagnostic quality using five points (1 and 2 = nondiagnostic; 3 = sufficient; 4 = adequate, 5 = optimal) between September 2021 and August 2022. Feedback was provided for scanners not achieving a PI-QUAL 5 score, and centers were invited to resubmit new imaging data using the modified protocol (phase II). Descriptive comparison of outcomes was made between the MRI scanners, feedback provided, and overall PI-QUAL scores. Results In phase I, 41 centers from 18 countries submitted a total of 355 multiparametric MRI studies from 71 scanners, with nine (13%) scanners achieving a PI-QUAL score of 3, 39 (55%) achieving a score of 4, and 23 (32%) achieving a score of 5. Of the 48 (n = 71 [68%]) scanners that received feedback to improve, the dynamic contrast-enhanced sequences were those that least adhered to the Prostate Imaging Reporting and Data System, version 2.1, criteria (44 of 48 [92%]), followed by diffusion-weighted imaging (20 of 48 [42%]) and T2-weighted imaging (19 of 48 [40%]). In phase II, 36 centers from 17 countries resubmitted revised studies, resulting in a total of 62 (n = 64 [97%]) scanners with a final PI-QUAL score of 5. Conclusion Substantial variation in global prostate MRI acquisition parameters as a measure of quality was observed, particularly with DCE sequences. Basic evaluation and modifications to MRI protocols using PI-QUAL can lead to substantial improvements in quality. Clinical trial registration no. NCT04571840 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Almansour and Chernyak in this issue.

Prostate MR image quality of apparent diffusion coefficient maps versus fractional intracellular volume maps from VERDICT MRI using the PI-QUAL score and a dedicated Likert scale for artefacts.

PURPOSE: This study aimed to assess the image quality of apparent diffusion coefficient (ADC) maps derived from conventional diffusion-weighted MRI and fractional intracellular volume maps (FIC) from VERDICT MRI (Vascular, Extracellular, Restricted Diffusion for Cytometry in Tumours) in patients from the INNOVATE trial. The inter-reader agreement was also assessed. METHODS: Two readers analysed both ADC and FIC maps from 57 patients enrolled in the INNOVATE prospective trial. Image quality was assessed using the Prostate Imaging Quality (PI-QUAL) score and a subjective image quality Likert score (Likert-IQ). The image quality of FIC and ADC were compared using a Wilcoxon Signed Ranks test. The inter-reader agreement was assessed with Cohen's kappa. RESULTS: There was no statistically significant difference between the PI-QUAL score for FIC datasets compared to ADC datasets for either reader (p = 0.240 and p = 0.614). Using the Likert-IQ score, FIC image quality was higher compared to ADC (p = 0.021) as assessed by reader-1 but not for reader-2 (p = 0.663). The inter-reader agreement was 'fair' for PI-QUAL scoring of datasets with FIC maps at 0.27 (95% confidence interval; 0.08-0.46) and ADC datasets at 0.39 (95% confidence interval 0.22-0.57). For Likert scoring, the inter-reader agreement was also 'fair' for FIC maps at 0.38 (95% confidence interval; 0.10-0.65) and substantial for ADC maps at 0.62 (95% confidence interval; 0.39-0.86). CONCLUSION: Image quality was comparable for FIC and ADC. The inter-reader agreement was similar when using PIQUAL for both FIC and ADC datasets but higher for ADC maps compared to FIC maps using the image quality Likert score.

Prostate Imaging after Focal Ablation (PI-FAB): A Proposal for a Scoring System for Multiparametric MRI of the Prostate After Focal Therapy.

At present there is no standardised system for scoring the appearance of the prostate on multiparametric magnetic resonance imaging (MRI) after focal ablation for localised prostate cancer. We propose a novel scoring system, the Prostate Imaging after Focal Ablation (PI-FAB) score, to fill this gap. PI-FAB involves a 3-point scale for rating MRI sequences in sequential order: (1) dynamic contrast-enhanced sequences; (2) diffusion-weighted imaging, split into assessment of the high-b-value sequence first and then the apparent diffusion coefficient map; and (3) T2-weighted imaging. It is essential that the pretreatment scan is also available to help with this assessment. We designed PI-FAB using our experience of reading postablation scans over the past 15 years and include details for four representative patients initially treated with high-intensity focus ultrasound at our institution to demonstrate the scoring system. We propose PI-FAB as a standardised method for evaluating prostate MRI scans after treatment with focal ablation. The next step is to evaluate its performance across multiple experienced readers of MRI after focal therapy in a clinical data set. PATIENT SUMMARY: We propose a scoring system called PI-FAB for assessing the appearance of magnetic resonance imaging scans of the prostate after focal treatment for localised prostate cancer. This will help clinicians in deciding on further follow-up.

A semi-automated software program to assess the impact of second reads in prostate MRI for equivocal lesions: results from a UK tertiary referral centre.

PURPOSE: To investigate the utility of a prostate magnetic resonance imaging (MRI) second read using a semi-automated software program in the one-stop clinic, where patients undergo multiparametric MRI, review and biopsy planning in one visit. We looked at concordance between readers for patients with equivocal scans and the possibility for biopsy deferral in this group. METHODS: We present data from 664 consecutive patients. Scans were reported by seven different expert genitourinary radiologists using dedicated software (MIM®) and a Likert scale. All scans were rescored by another expert genitourinary radiologist using a customised workflow for second reads that includes annotated biopsy contours for accurate visual targeting. The number of scans in which a biopsy could have been deferred using biopsy results and prostate specific antigen density was assessed. Gleason score ≥ 3 + 4 was considered clinically significant disease. Concordance between first and second reads for equivocal scans (Likert 3) was evaluated. RESULTS: A total of 209/664 (31%) patients scored Likert 3 on first read, 128 of which (61%) were concordant after second read. 103/209 (49%) of patients with Likert 3 scans were biopsied, with clinically significant disease in 31 (30%) cases. Considering Likert 3 scans that were both downgraded and biopsied using the workflow-generated biopsy contours, 25/103 (24%) biopsies could have been deferred. CONCLUSIONS: Implementing a semi-automated workflow for accurate lesion contouring and targeting biopsies is helpful during the one-stop clinic. We observed a reduction of indeterminate scans after second reading and almost a quarter of biopsies could have been deferred, reducing the potential biopsy-related side effects.

Magnetic Resonance Imaging Follow-up of Targeted Biopsy-negative Prostate Lesions.

BACKGROUND: The optimal radiological follow-up of prostate lesions negative on magnetic resonance imaging (MRI)-targeted biopsy (MRI-TB) is yet to be optimised. OBJECTIVE: To present medium-term radiological and clinical follow-up of biopsy-negative lesions. DESIGN, SETTING, AND PARTICIPANTS: The records for men who underwent multiparametric MRI at the UCLH one-stop clinic for suspected prostate cancer between September 2017 and March 2020 were reviewed (n = 1199). Patients with Likert 4 or 5 lesions were considered (n = 495), and those with a subsequent negative MRI-TB comprised the final study population (n = 91). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Baseline and follow-up MRI and biopsy data (including prostate-specific antigen [PSA], prostate volume, radiological scores, and presence of any noncancerous pathology) were extracted from reports. The last follow-up date was the date of the last test or review in clinic. RESULTS AND LIMITATIONS: Median follow-up was 1.8 yr (656 d, interquartile range [IQR] 359-1008). At baseline, the median age was 65.4 yr (IQR 60.7-70.0), median PSA was 7.1 ng/ml (IQR 4.7-10.0), median prostate volume was 54 ml (IQR 39.5-75.0), and median PSA density (PSAD) was 0.13 ng/ml2 (IQR 0.09-0.18). Eighty-six men (95%) had Likert 4 lesions, while the remaining five (5%) had Likert 5 lesions. Only 21 men (23%) had a single lesion; most had at least two. Atrophy was the most prevalent pathology on MRI-TB, present in 64 men (74%), and followed by acute inflammation in 42 (46%), prostatic intraepithelial neoplasia in 33 (36%), chronic inflammation in 18 (20%), atypia in 13 (14%), and granulomatous inflammation in three (3%). Fifty-eight men had a second MRI study (median 376 d, IQR 361-412). At the second MRI, median PSAD decreased to 0.11 ng/ml2 (IQR 0.08-0.18). A Likert 4 or 5 score persisted only in five men (9%); 40 men (69%) were scored Likert 3, while the remaining 13 (22%) were scored Likert 2 (no lesion). Of 45 men with a Likert ≥3 score, most only had one lesion at the second MRI (28 men; 62%). Of six men with repeat MRI-TB during the study period, two were subsequently diagnosed with prostate cancer and both had persistent Likert 4 scores (at baseline and at least one follow-up MRI). CONCLUSIONS: Most biopsy-negative MRI lesions in the prostate resolve over time, but any persistent lesions should be closely monitored. PATIENT SUMMARY: Lesions in the prostate detected via magnetic resonance imaging (MRI) scans that are negative for cancer on biopsy usually resolve. Repeat MRI can indicate persistent lesions that might need a second biopsy.

Standardisation of prostate multiparametric MRI across a hospital network: a London experience.

OBJECTIVES: National guidelines recommend prostate multiparametric (mp) MRI in men with suspected prostate cancer before biopsy. In this study, we explore prostate mpMRI protocols across 14 London hospitals and determine whether standardisation improves diagnostic quality. METHODS: An MRI physicist facilitated mpMRI set-up across several regional hospitals, working together with experienced uroradiologists who judged diagnostic quality. Radiologists from the 14 hospitals participated in the assessment and optimisation of prostate mpMRI image quality, assessed according to both PiRADSv2 recommendations and on the ability to "rule in" and/or "rule out" prostate cancer. Image quality and sequence parameters of representative mpMRI scans were evaluated across 23 MR scanners. Optimisation visits were performed to improve image quality, and 2 radiologists scored the image quality pre- and post-optimisation. RESULTS: 20/23 mpMRI protocols, consisting of 111 sequences, were optimised by modifying their sequence parameters. Pre-optimisation, only 15% of T2W images were non-diagnostic, whereas 40% of ADC maps, 50% of high b-value DWI and 41% of DCE-MRI were considered non-diagnostic. Post-optimisation, the scores were increased with 80% of ADC maps, 74% of high b-value DWI and 88% of DCE-MRI to be partially or fully diagnostic. T2W sequences were not optimised, due to their higher baseline quality scores. CONCLUSIONS: Targeted intervention at a regional level can improve the diagnostic quality of prostate mpMRI protocols, with implications for improving prostate cancer detection rates and targeted biopsies.

Feasibility of a hearing screening programme using DPOAEs in 3-year-old children in South Auckland.

OBJECTIVES: In New Zealand (NZ), permanent hearing loss is associated with higher levels of socioeconomic deprivation, and is more prevalent amongst Maori and Pacific than NZ European children. Many of these hearing losses are detected through newborn hearing screening, however there is a need to screen children again later, to look for childhood hearing losses that are either late-onset, progressive, or acquired. This study evaluated the feasibility of implementing an objective screening protocol that includes otoscopy, distortion product otoacoustic emission screening (DPOAEs), and tympanometry. It also evaluated the feasibility of using Early Learning Centres (ELCs) to contact families, recruit, and test 3-year-old children from an area of high socioeconomic deprivation in Auckland, New Zealand. METHODS: Sixty-one 3-year-old children were recruited from ELCs within the Counties Manukau District Health Board (CMDHB) region which services the geographical area of South Auckland. The first part of the screening protocol consisted of otoscopy, DPOAEs, and tympanometry. Children identified with hearing loss and/or middle ear problems were either referred directly to Otolaryngology/Audiology at the local hospital or invited back for a re-screen 4-8 weeks later. Children who were referred from the screening were followed up to track and document their subsequent clinical pathway through the public health system. RESULTS: Mean overall time for the screening protocol was 4.1 minutes. The combination of otoscopy, DPOAEs, and tympanometry was well accepted by the 3-year-old children. DPOAE amplitude and signal-to-noise ratio results significantly differentiated between different tympanometry results, providing support for this combination of measures to accurately screen for hearing loss and/or middle ear disease. Thirty-eight of the 61 children (62%) passed the screening protocol. Of the remaining 23 children, five were referred to the hospital after not passing the screening, but following more in-depth audiological testing, were discharged with normal hearing. Six children referred to the hospital were diagnosed with varying degrees of conductive hearing loss, and two of the six received grommet insertion surgery. The remaining 12 children who were referred to the hospital were lost to follow-up, highlighting challenges for the families to successfully navigate the current public health system. CONCLUSION: This study demonstrates that identifying hearing loss and ear disease in 3-year-old children in the pre-school setting is feasible. A number of barriers were identified in the current health system that contribute to a large proportion of children referred with suspected hearing loss and ear disease being unsuccessful in accessing Otolaryngology/Audiology clinical care through the local hospital.

Strengthening quality assurance by implementing an evidence-based revision of a ward accreditation programme.

Ward accreditation is fundamental in contemporary healthcare delivery. One NHS trust in southwest England that had been placed in special measures introduced a ward accreditation programme - known as the ASPIRE programme - but the trust's senior nursing leadership team raised concerns about the level of quality assurance provided. Therefore, the trust revised its newly created ward accreditation programme, referring to the evidence base to re-evaluate the metrics used for assessment. Five new elements, including direct registered nurse care time and ward climate, were introduced in the accreditation process. The revision improved confidence in the quality assurance provided by the programme, which became central to the trust's overall improvement plans.

MRI in the Management of Prostate Cancer.

Multiparametric MRI has a changing role in prostate cancer diagnosis. Internationally recognized consensus documents such as prostate imaging reporting and data system version have been developed and adapted to standardize the acquisition and reporting of prostate MRI. The improvement in scanning techniques and development of highly sensitive functional sequences have improved the detection of clinically significant prostate cancer as well as treatment planning and follow up. This has led to a recent NICE recommendation to use prostate MRI as the initial investigation in men with clinically suspected localized disease. The results of several recent international MRI prostate trials are influencing the way imaging is used to stratify which patients require a prostate biopsy as well as how MRI guidance is used to target biopsies.

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.

OBJECTIVE: To report medium-term oncological outcomes in men receiving primary focal treatment with high-intensity focused ultrasonography ( HIFU) for prostate cancer (PCa). PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

'Asymptomatic' South Auckland preschool children have significant hearing loss and middle ear disease.

BACKGROUND: Seven hundred children were recalled for hearing screening at age 2-3 years due to a problem with their newborn hearing screen. They had all been well babies with no identified risk factors for hearing loss and hence were not scheduled for targeted follow-up to retest hearing. METHODS: There were 485 children (69%) that attended the recall. The average age was 36 months (SD 3.7). Family ethnicity was Pacific Island (36%), Asian (26%), NZ European (13%), and Maori (11%), and there was a high level of deprivation in the study population. Children were screened using distortion product otoacoustic emission (DPOAE) and a parent or caregiver completed a 14-item questionnaire about ear health. The children that did not pass screening were given appointments for audiology testing. Children with hearing loss and/or middle ear problems were referred for otolaryngology review and further hearing assessments. RESULTS: About one third (36%; n = 176) of children did not pass DPOAE screening; 82 (17%) had abnormal type B tympanograms and hearing loss; 29 underwent insertion of ventilation tubes, and one had a perforated tympanic membrane. There was a significant association between failed tympanometry and hearing loss (Chi-squared = 16.67, p < .001). Five children had permanent sensorineural hearing loss (SNHL), two of whom required cochlear implants for idiopathic hearing loss, with no specific risk factors. Overall 380 of 485 children screened were deemed to have normal hearing (i.e. 22% failed hearing). From the questionnaire, 15% of the caregivers with no suspicion of hearing problems did have children with significant hearing loss. Regression analysis showed that Pacific/Maori ethnicity was significantly associated with risk of hearing loss, together with questionnaire items identifying hearing problems and breathing problems. CONCLUSIONS: There is a high proportion of children in South Auckland with unsuspected hearing loss; a different approach to hearing screening is warranted for this population with high rates of middle ear disease at age 3.

Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cancer.

PURPOSE: Irreversible electroporation has attractive attributes for focal ablation, namely nonthermal effect, precise demarcation of treatment and tissue selectivity. We report a prospective development study investigating focal irreversible electroporation. MATERIALS AND METHODS: A total of 20 men with certain characteristics were recruited for study, including a visible index lesion on anterior magnetic resonance imaging that was concordant with transperineal targeted and template prostate mapping biopsy, absent clinically significant disease noted elsewhere (University College London definition 2) and prostate specific antigen 15 ng/ml or less. Our primary objective was to determine the side effect profile at 12 months. Secondary objectives included the domain specific toxicity profile using patient reported outcomes and early disease control using magnetic resonance imaging targeted biopsy. RESULTS: A total of 19 patients with median age of 60 years (IQR 53-66) and median prostate specific antigen 7.75 ng/ml (IQR 5.5-10.03) were treated. Of the patients 16 were available for estimating the first outcome as 1 was lost to followup and 2 had received another form of treatment by study end. All 16 men had pad-free/leak-free continence at 12 months. The proportion of men with erection sufficient for penetration decreased from 12 of 16 (75%) to 11 of 16 (69%). No serious adverse events were recorded. There was a statistically significant improvement in urinary symptoms according to changes in UCLA-EPIC (UCLA Expanded Prostate Cancer Index Composite) and I-PSS (International Prostate Symptom Score) (p = 0.039 and 0.001, respectively). Erectile function remained stable according to the change in IIEF-15 (15-Item International Index of Erectile Function) (p = 0.572). Median prostate specific antigen significantly decreased to 1.71 ng/ml (p = 0.001). One man refused followup biopsy. No residual disease was found in 11 patients (61.1%). One man (5.6%) harbored clinically insignificant disease and the remaining 6 (33.3%) harbored clinically significant disease. CONCLUSIONS: Focal irreversible electroporation has low genitourinary toxicity. Additional studies are needed to optimize patient selection and treatment parameters.

Prostate-specific antigen vs. magnetic resonance imaging parameters for assessing oncological outcomes after high intensity-focused ultrasound focal therapy for localized prostate cancer.

INTRODUCTION: Focal therapy for localized prostate cancer has the potential for oncological control without the side effects of radical therapies. However, there is currently no validated method for monitoring treatment success. We assessed the diagnostic performance of prostate-specific antigen (PSA) parameters and MRI compared to histological outcomes following focal therapy. PATIENTS AND METHODS: Patients from 3 Ethics Review Board approved prospective studies of focal high intensity-focused ultrasound (HIFU) (Sonablate 500) for localized prostate cancer (T1c-T3a, Gleason grade≤4+3, and PSA≤20). Post-HIFU PSA nadir, 6-month PSA, PSA density, and early (<3wk) and late (6mo) MRI (T2-weighted, dynamic contrast-enhanced±diffusion-weighted) was assessed for predictive accuracy of cancer on postoperative biopsy, using receiver operating characteristic (ROC) analysis and sensitivity, specificity, and positive and negative predictive estimates. ROC areas for MRI and PSA were compared. Calculations for statistical significance (P≤0.05) were obtained in a subset of patients comparing area under ROC for 6-month MRI and PSA criteria, across 4 different histological definitions of disease significance. RESULTS: Of 118 men, 111 underwent at least 1 postoperative biopsy (median 6 cores), with an overall positive biopsy rate of 37% (41/118), over a mean follow-up period of 716 days post-HIFU. Areas under ROC for early and late MRI were (depending on definition of significant disease) 0.65 to 0.76 and 0.77 to 0.85, respectively, with sensitivity, specificity, and negative predictive values of 68% to 91%, 52% to 55%, and 85% to 98% (early MRI), and 63% to 80%, 67% to 73%, and 86% to 97% (late MRI). The area under the ROC curve was statistically significantly higher for late MRI than 6 months and nadir PSA for residual disease >3mm or any Gleason 4 tumor. CONCLUSIONS: Early and late MRI performed better than PSA measurements in the detection of residual tumor after focal therapy.

Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort.

BACKGROUND: High-intensity focused ultrasound (HIFU) is a minimally-invasive treatment for nonmetastatic prostate cancer. OBJECTIVE: To report medium-term outcomes in men receiving primary whole-gland HIFU from a national multi-centre registry cohort. DESIGN, SETTING, AND PARTICIPANTS: Five-hundred and sixty-nine patients at eight hospitals were entered into an academic registry. INTERVENTION: Whole-gland HIFU (Sonablate 500) for primary nonmetastatic prostate cancer. Redo-HIFU was permitted as part of the intervention. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Our primary failure-free survival outcome incorporated no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer-specific mortality. Secondary outcomes included adverse events and genitourinary function. RESULTS AND LIMITATIONS: Mean age was 65 yr (47-87 yr). Median prostate-specific antigen was 7.0 ng/ml (interquartile range 4.4-10.2). National Comprehensive Cancer Network low-, intermediate-, and high-risk disease was 161 (28%), 321 (56%), and 81 (14%), respectively. One hundred and sixty three of 569 (29%) required a total of 185 redo-HIFU procedures. Median follow-up was 46 (interquartile range 23-61) mo. Failure-free survival at 5 yr after first HIFU was 70% (95% confidence interval [CI]: 64-74). This was 87% (95% CI: 78-93), 63% (95% CI: 56-70), and 58% (95% CI: 32-77) for National Comprehensive Cancer Network low-, intermediate-, and high-risk groups, respectively. Fifty eight of 754 (7.7%) had one urinary tract infection, 22/574 (2.9%) a recurrent urinary tract infection, 22/754 (3%) epididymo-orchitis, 227/754 (30%) endoscopic interventions, 1/754 (0.13%) recto-urethral fistula, and 1/754 (0.13%) osteitis pubis. Of 206 known to be pad-free pre-HIFU, 183/206 (88%) remained pad free, and of 236 with good baseline erectile function, 91/236 (39%) maintained good function. The main limitation is lack of long-term data. CONCLUSIONS: Whole-gland HIFU is a repeatable day-case treatment that confers low rates of urinary incontinence. Disease control at a median of just under 5 yr of follow-up demonstrates its potential as a treatment for nonmetastatic prostate cancer. Endoscopic interventions and erectile dysfunction rates are similar to other whole-gland treatments. PATIENT SUMMARY: In this report we looked at the 5-yr outcomes following whole-gland high-intensity focused ultrasound treatment for prostate cancer and found that cancer control was acceptable with a low risk of urine leakage. However, risk of erectile dysfunction and further operations was similar to other whole-gland treatments like surgery and radiotherapy.