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Objective: To report outcomes within the Rapid Assessment for Prostate Imaging and Diagnosis (RAPID) diagnostic pathway, introduced to reduce patient and healthcare burdens and standardize delivery of pre‐biopsy multiparametric magnetic resonance imaging (MRI) and transperineal biopsy. Patients and Methods: A total of 2130 patients from three centres who completed the RAPID pathway (3 April 2017 to 31 March 2020) were consecutively entered as a prospective registry. These patients were also compared to a pre‐RAPID cohort of 2435 patients. Patients on the RAPID pathway with an MRI score 4 or 5 and those with PSA density ≥0.12 and an MRI score 3 were advised to undergo a biopsy. Primary outcomes were rates of biopsy and cancer detection. Secondary outcomes included comparison of transperineal biopsy techniques, patient acceptability and changes in time to diagnosis before and after the introduction of RAPID. Results: The median patient age and PSA level were 66 years and 6.6 ng/mL, respectively. Biopsy could be omitted in 43% of patients (920/2130). A further 7.9% of patients (168/2130) declined a recommendation for biopsy. The percentage of biopsies avoided among sites varied (45% vs 36% vs 51%; P < 0.001). In all, 30% (221/742) had a local anaesthetic (grid and stepper) transperineal biopsy. Clinically significant cancer detection (any Gleason score ≥3 + 4) was 26% (560/2130) and detection of Gleason score 3 + 3 alone constituted 5.8% (124/2130); detection of Gleason score 3 + 3 did not significantly vary among sites (P = 0.7). Among participants who received a transperineal targeted biopsy, there was no difference in cancer detection rates among local anaesthetic, sedation and general anaesthetic groups. In the 2435 patients from the pre‐RAPID cohor, time to diagnosis was 32.1 days (95% confidence interval [CI] 29.3–34.9) compared to 15.9 days (95% CI 12.9–34.9) in the RAPID group. A total of 141 consecutive patient satisfaction surveys indicated a high satisfaction rate with the pathway; 50% indicated a preference for having all tests on a single day. Conclusions: The RAPID prostate cancer diagnostic pathway allows 43% of men to avoid a biopsy while preserving good detection of clinically significant cancers and low detection of insignificant cancers, although there were some centre‐level variations. [ABSTRACT FROM AUTHOR]

Objective: To review of the existing literature, current guidelines and standard of practice related to prostate cancer in transgender women, as the transgender population share many of the same healthcare needs as their cisgender counterparts, but may have additional specialist needs. Materials and methods: We performed a non‐systematic review of the literature, current guidelines and standard of practice related to prostate cancer in transgender women. Results: Our search revealed 10 case reports of prostate cancer in transgender women, four specialist opinion papers, six cohort studies, and four systematic reviews. The information in these publications were assimilated to produce a review of prostate cancer in transgender women. Conclusion: The risk of prostate cancer in transgender women who are not on gender‐affirming hormone therapy (GAHT) or who have not had gender‐affirming surgery (GAS) and gender non‐conforming individuals (who may never commence GAHT or have GAS) is the same as that in the cis male population. In these patients, healthcare professionals need to be able to discuss screening, diagnostic and treatment options considering future wishes for gender‐affirming treatment. Prostate cancer incidence in transgender women on GAHT or following GAS is lower than age‐matched cis‐male counterparts, but diagnosis and treatment is more nuanced. The present review discusses the existing literature about development and incidence of prostate cancer in this population, and makes recommendations about screening, the usefulness of diagnostic tools e.g. prostate‐specific antigen and magnetic resonance imaging, and considerations when formulating treatment. Potential directions for future research are discussed, which will hopefully lead to development of robust evidence‐based guidelines for the diagnosis and management of prostate cancer in transgender women. [ABSTRACT FROM AUTHOR]

Objectives: To report toxicity of treatment observed in men participating in the Robotic surgery After Focal Therapy (RAFT) clinical trial. Patients and Methods: Men were eligible for this prospective single group interventional study if they had histologically confirmed recurrent/residual prostate adenocarcinoma following primary FT. The short‐form Expanded Prostate Cancer Index Composite (EPIC‐26) measured prior to salvage robotic prostatectomy (S‐RARP) and 3‐monthly post‐operatively together with Clavien‐Dindo complications (I–IV). Secondary outcomes included biochemical recurrence‐free survival (BCFS) following surgery and need for salvage treatment after surgery. This study is registered with ClinicalTrials.gov NCT03011606. Results: Twenty‐four men were recruited between February 2016 and September 2018. 1 patient withdrew from the trial after consenting and before S‐RARP. 23 men completed 12‐month post S‐RARP follow‐up. Median EPIC‐26 urinary continence scores initially deteriorated after 3 months (82.4 vs 100) but there was no statistically significant difference from baseline at 12 months (100 vs 100, P = 0.31). Median lower urinary tract symptom scores improved after 12 months compared to baseline (93.8 vs 87.5, P = 0.01). At 12 months, 19/23 (83%) were pad‐free and 22/23 (96%) required 0/1 pads. Median sexual function subscale scores deteriorated and remained low at 12 months (22.2 vs 58.3, P < 0.001). Utilising a minimally important difference of nine points, at 12 months after surgery 17/23 (74%) reported urinary continence to be 'better' or 'not different' to pre‐operative baseline. The corresponding figure for sexual function (utilising a minimally important difference of 12 points) was 7/23 (30%). There was no statistically significant difference on median bowel/hormonal subscale scores. Only a single patient had a post‐operative complication (Clavien‐Dindo Grade I). BCFS at 12 months after surgery was 82.6% (95% confidence interval [CI]: 60.1–93.1%) while 4/23 (17%) received salvage radiation. Conclusions: The RAFT clinical trial suggests toxicity of surgery after FT is low, with good urinary function outcomes, albeit sexual function deteriorated overall. Oncological outcomes at 12 months appear acceptable. [ABSTRACT FROM AUTHOR]

Objectives: To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation‐based surgical training and the development process for an evidence‐based training curriculum, to be delivered as an educational intervention. Participants and Methods: This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation‐based training (SBT) or non‐simulation‐based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two‐round Delphi process. Results: A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO‐Mentor (Simbionix, Lod, Israel) VR Simulator, Uro‐Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi‐rigid and flexible URS. Respondents also selected relevant non‐technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability. Conclusions: SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence‐based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261). [ABSTRACT FROM AUTHOR]

Objectives: To assess change in functional outcomes after a second focal high‐intensity focused ultrasonography (HIFU) treatment compared with outcomes after one focal HIFU treatment. Patients and Methods: 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 3 years. 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. Results: 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 65.6 years, and 7.9 and 8.4 ng/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 1–2 years, 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 1–2 years, 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 1–2 years (P = 0.03) and +1.2 at 2–3 years (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 1–2 years (P = 0.60) and −0.5 at 2–3 years (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 1–2 years and 2.6% at 2–3 years. Conclusion: 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. [ABSTRACT FROM AUTHOR]

Objective: To determine the additional diagnostic value of diffusion‐weighted imaging (DWI) and dynamic contrast‐enhanced imaging (DCE) in men requiring a repeat biopsy within the PICTURE study. Patients and Methods: PICTURE was a paired‐cohort confirmatory study in which 249 men who required further risk stratification after a previous non‐magnetic resonance imaging (MRI)‐guided transrectal ultrasonography‐guided biopsy underwent a 3‐Tesla (3T) multiparametic (mp)MRI consisting of T2‐weighted imaging (T2W), DWI and DCE, followed by transperineal template prostate mapping biopsy. Each mpMRI was reported using a LIKERT score in a sequential blinded manner to generate scores for T2W, T2W+DWI and T2W+DWI+DCE. Area under the receiver‐operating characteristic curve (AUROC) analysis was performed to compare the diagnostic accuracy of each combination. The threshold for a positive mpMRI was set at a LIKERT score ≥3. Clinically significant prostate cancer was analysed across a range of definitions including UCL/Ahmed definition 1 (primary definition), UCL/Ahmed definition 2, any Gleason ≥3 + 4 and any Gleason ≥4 + 3. Results: Of 249 men, sequential MRI reporting was available for 246. There was a higher rate of equivocal lesions (44.6%) using T2W alone compared to the addition of DWI (23.9%) and DCE (19.8%). Using the primary definition of clinically significant disease, there was no significant difference in the overall accuracy between T2W, with an AUROC of 0.74 (95% confidence interval [CI] 0.68–0.80), T2W+DWI at 0.76 (95% CI 0.71–0.82), and T2W+DWI+DCE, with an AUROC of 0.77 (95% CI 0.71–0.82; P = 0.55). The AUROC values remained comparable using other definitions of clinically significant disease including UCL/Ahmed definition 2 (P = 0.79), Gleason ≥3 + 4 (P = 0.53) and Gleason ≥4 + 3 (P = 0.53). Conclusions: Using 3T MRI, a high level of diagnostic accuracy can be achieved using T2W as a single parameter in men with a prior biopsy; however, such a strategy can lead to a higher rate of equivocal lesions. [ABSTRACT FROM AUTHOR]

Objective: To compare the clinical validity and utility of Likert assessment and the Prostate Imaging Reporting and Data System (PI‐RADS) v2 in the detection of clinically significant and insignificant prostate cancer. Patients and Methods: A total of 489 pre‐biopsy multiparametric magnetic resonance imaging (mpMRI) scans in consecutive patients were subject to prospective paired reporting using both Likert and PI‐RADS v2 by expert uro‐radiologists. Patients were offered biopsy for any Likert or PI‐RADS score ≥4 or a score of 3 with PSA density ≥0.12 ng/mL/mL. Utility was evaluated in terms of proportion biopsied, and proportion of clinically significant and insignificant cancer detected (both overall and on a 'per score' basis). In those patients biopsied, the overall accuracy of each system was assessed by calculating total and partial area under the receiver‐operating characteristic (ROC) curves. The primary threshold of significance was Gleason ≥3 + 4. Secondary thresholds of Gleason ≥4 + 3, Ahmed/UCL1 (Gleason ≥4 + 3 or maximum cancer core length [CCL] ≥6 or total CCL≥6) and Ahmed/UCL2 (Gleason ≥3 + 4 or maximum CCL ≥4 or total CCL ≥6) were also used. Results: The median (interquartile range [IQR]) age was 66 (60–72) years and the median (IQR) prostate‐specific antigen level was 7 (5–10) ng/mL. A similar proportion of men met the biopsy threshold and underwent biopsy in both groups (83.8% [Likert] vs 84.8% [PI‐RADS v2]; P = 0.704). The Likert system predicted more clinically significant cancers than PI‐RADS across all disease thresholds. Rates of insignificant cancers were comparable in each group. ROC analysis of biopsied patients showed that, although both scoring systems performed well as predictors of significant cancer, Likert scoring was superior to PI‐RADS v2, exhibiting higher total and partial areas under the ROC curve. Conclusions: Both scoring systems demonstrated good diagnostic performance, with similar rates of decision to biopsy. Overall, Likert was superior by all definitions of clinically significant prostate cancer. It has the advantages of being flexible, intuitive and allowing inclusion of clinical data. However, its use should only be considered once radiologists have developed sufficient experience in reporting prostate mpMRI. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether patients with Gleason 3 + 4 cancer on transrectal biopsy are upgraded after undergoing transperineal magnetic resonance imaging (MRI)‐targeted biopsy and whether this has implications for current clinical practice. Patients and Methods: In this retrospective analysis we examined 107 consecutive patients presenting at a single tertiary referral centre (July 2012 to July 2016) with prostate cancer of Gleason score 3 + 4 on transrectal ultrasonography (TRUS)‐guided systematic non‐targeted biopsy who then underwent a multiparametric MRI followed by MRI‐targeted transperineal prostate biopsy for accurate risk stratification and localization. Results: The patients' mean (sd) age was 67.0 (8.0) years, and they had a median (interquartile range) PSA concentration of 6.2 (4.7–9.6) ng/mL. Of the 107 patients, 84 (78.5%) had Gleason 3 + 4 on both transrectal systematic biopsy and transperineal MRI‐targeted biopsy. Nineteen patients (17.8%) were upgraded to Gleason 4 + 3, three patients (3.0%) to Gleason 4 + 4 and one patient (1.0%) to Gleason 4 + 5. These differences were significant (P = 0.0006). Likewise, 23/107 patients (22%) had higher‐risk disease based on their targeted biopsies. Conclusion: The use of targeted biopsy in men with impalpable cancer, ultimately upgraded one in five patients from favourable‐intermediate‐ to unfavourable‐intermediate‐risk disease or worse. This has significant clinical implications for men considering active surveillance or radical treatment. Our risk calculators must now be validated using these data from targeted biopsy as the technique becomes widely adopted. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abbreviations CPD continuing professional development DCE dynamic contrast-enhanced MDT multidisciplinary team mpMRI multiparametric MRI Multiparametric MRI (mpMRI) of the prostate is now recommended as the initial investigation method for men with suspected prostate cancer within both UK and international guidelines. Defining the learning curve for multiparametric magnetic resonance imaging (MRI) of the prostate using MRI-transrectal ultrasonography (TRUS) fusion-guided transperineal prostate biopsies as a validation tool. [Extracted from the article]

Objectives: To identify areas of agreement and disagreement in the implementation of multi‐parametric magnetic resonance imaging (mpMRI) of the prostate in the diagnostic pathway. Materials and Methods: Fifteen UK experts in prostate mpMRI and/or prostate cancer management across the UK (involving nine NHS centres to provide for geographical spread) participated in a consensus meeting following the Research and Development Corporation and University of California‐Los Angeles (UCLA‐RAND) Appropriateness Method, and were moderated by an independent chair. The experts considered 354 items pertaining to who can request an mpMRI, prostate mpMRI protocol, reporting guidelines, training, quality assurance (QA) and patient management based on mpMRI levels of suspicion for cancer. Each item was rated for agreement on a 9‐point scale. A panel median score of ≥7 constituted ‘agreement’ for an item; for an item to reach ‘consensus’, a panel majority scoring was required. Results: Consensus was reached on 59% of items (208/354); these were used to provide recommendations for the implementation of prostate mpMRI in the UK. Key findings include prostate mpMRI requests should be made in consultation with the urological team; mpMRI scanners should undergo QA checks to guarantee consistently high diagnostic quality scans; scans should only be reported by trained and experienced radiologists to ensure that men with unsuspicious prostate mpMRI might consider avoiding an immediate biopsy. Conclusions: Our consensus statements demonstrate a set of criteria that are required for the practical dissemination of consistently high‐quality prostate mpMRI as a diagnostic test before biopsy in men at risk. [ABSTRACT FROM AUTHOR]

Purpose: Image‐guided systems that fuse magnetic resonance imaging (MRI) with three‐dimensional (3D) ultrasound (US) images for performing targeted prostate needle biopsy and minimally invasive treatments for prostate cancer are of increasing clinical interest. To date, a wide range of different accuracy estimation procedures and error metrics have been reported, which makes comparing the performance of different systems difficult. Methods: A set of nine measures are presented to assess the accuracy of MRI‐US image registration, needle positioning, needle guidance, and overall system error, with the aim of providing a methodology for estimating the accuracy of instrument placement using a MR/US‐guided transperineal approach. Results: Using the SmartTarget fusion system, an MRI‐US image alignment error was determined to be 2.0 ± 1.0 mm (mean ± SD), and an overall system instrument targeting error of 3.0 ± 1.2 mm. Three needle deployments for each target phantom lesion was found to result in a 100% lesion hit rate and a median predicted cancer core length of 5.2 mm. Conclusions: The application of a comprehensive, unbiased validation assessment for MR/US guided systems can provide useful information on system performance for quality assurance and system comparison. Furthermore, such an analysis can be helpful in identifying relationships between these errors, providing insight into the technical behavior of these systems. [ABSTRACT FROM AUTHOR]

Objective To develop a core outcome set ( COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio; which is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. Patients, Subjects and Methods A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 patients with prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals ( HCPs; cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients. Results The final COS included 19 outcomes. In all, 12 apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, and sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side-effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. Conclusion We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials. [ABSTRACT FROM AUTHOR]

Objectives To determine whether modified transperineal template prostate-mapping ( TTPM) biopsy protocols, altering the template or the biopsy density, have sensitivity and negative predictive value ( NPV) equal to full 5-mm TTPM. Patients and Methods Retrospective analysis of an institutional registry including treatment-naïve men undergoing 5-mm TTPM biopsy analysed in a 20-zone fashion. The value of three modified strategies was assessed by comparing the information provided by selected zones against full 5-mm TTPM. Strategy 1, did not consider the findings of anterior areas; strategies 2 and 3 simulated a reduced biopsy density by excluding intervening zones. A bootstrapping technique was used to calculate reliable estimates of sensitivity and NPV of these three strategies for the detection of clinically significant disease (maximum cancer core length ≥4 mm and/or Gleason score ≥3 + 4). Results In all, 391 men with a median (interquartile range, IQR) age of 62 (58-67) years were included. The median ( IQR) PSA level and PSA density were 6.9 (4.8-10) ng/mL and 0.17 ( IQR 0.12-0.25) ng/mL/mL, respectively. A median ( IQR) of 6 (2-9) cores out of 48 (33-63) taken per man were positive for prostate cancer. No cancer was detected in 67 men (17%), whilst low-, intermediate- and high-risk disease was identified in 78 (20%), 80 (21%), and 166 (42%), respectively. Strategy 1, 2 and 3 had sensitivities of 78% [95% confidence interval ( CI) 73-84%], 85% (95% CI 80-90%) and 84% (95% CI 79-89%), respectively. The NPVs of the three strategies were 73% (95% CI 67-80%), 80% (95% CI 74-86%) and 79% (95% CI 72-84%), respectively. Conclusion Altering the template or decreasing sampling density has a substantial negative impact on the ability of TTPM biopsy to exclude clinically significant disease. This should be considered when modified TTPM biopsy strategies are used to select men for tissue-preserving approaches, and when modified TTPM are used to validate new diagnostic tests. [ABSTRACT FROM AUTHOR]

The second meeting of the Blue Skies Forum took place in Downing College, Cambridge, in April 2013, with the objective of focusing attention on new initiatives in the diagnosis and treatment of prostate cancer, in particular on areas of research that aim to identify aggressive disease. The meeting was hosted by Prostate Cancer UK and supported by The Howard Foundation. Copyright © 2013 John Wiley & Sons [ABSTRACT FROM AUTHOR]

Objective To evaluate the feasibility of using computer-assisted, deformable image registration software to enable three-dimensional (3 D), multi-parametric (mp) magnetic resonance imaging ( MRI)-derived information on tumour location and extent, to inform the planning and conduct of focal high-intensity focused ultrasound ( HIFU) therapy., Patients and Methods A nested pilot study of 26 consecutive men with a visible discrete focus on mp MRI, correlating with positive histology on transperineal template mapping biopsy, who underwent focal HIFU ( Sonablate 500®) within a prospective, Ethics Committee-approved multicentre trial (' INDEX')., Non-rigid image registration software developed in our institution was used to transfer data on the location and limits of the index lesion as defined by mp MRI., Manual contouring of the prostate capsule and histologically confirmed MR-visible lesion was performed preoperatively by a urologist and uro-radiologist., A deformable patient-specific computer model, which captures the location of the target lesion, was automatically generated for each patient and registered to a 3 D transrectal ultrasonography ( US) volume using a small number (10-20) of manually defined capsule points., During the focal HIFU, the urologist could add additional sonications after image-registration if it was felt that the original treatment plan did not cover the lesion sufficiently with a margin., Results Prostate capsule and lesion contouring was achieved in <5 min preoperatively. The mean (range) time taken to register images was 6 (3-16) min., Additional treatment sonications were added in 13 of 26 cases leading to a mean (range) additional treatment time of 45 (9-90) s., Conclusion Non-rigid MR-US registration is feasible, efficient and can locate lesions on US., The process has potential for improved accuracy of focal treatments, and improved diagnostic sampling strategies for prostate cancer., Further work on whether deformable MR-US registration impacts on efficacy is required. [ABSTRACT FROM AUTHOR]

Multiparametric magnetic resonance imaging (mpMRI) is increasingly being used earlier in the prostate cancer diagnostic pathway in order to detect and localize disease. Its results can be used to help decide on the indication, type, and localization of a prostate biopsy for cancer diagnosis. In addition, mpMRI has the potential to contribute information on the characterization, or aggressiveness, of detected cancers including tumor progression over time. There is considerable variation in the way results of different MRI sequences are reported. We conducted a review of scoring systems that have been used in the detection and characterization of prostate cancer. This revealed that existing scoring and reporting systems differ in purpose, scale, and range. We evaluate these differences in this review. This first step in collating all methods of scoring and reporting mpMRI will ultimately lead to consensus approaches to develop a standardized reporting scheme that can be widely adopted and validated to ensure comparability of research outputs and optimal clinical practice. J. Magn. Reson. Imaging 2013;37:48-58. [ABSTRACT FROM AUTHOR]

Study Type - Diagnostic (validating cohort) Level of Evidence 1b What's known on the subject? and What does the study add? Transrectal ultrasonography (TRUS)-guided biopsies can miss prostate cancer and misclassify risk in a diagnostic setting; the exact extent to which it does so in a repeat biopsy strategy in men with low-intermediate risk prostate cancer is unknown. A simulation study of different biopsy strategies showed that repeat 12-core TRUS biopsy performs poorly. Adding anterior sampling improves on this but the highest accuracy is achieved using transperineal template prostate mapping using a 5 mm sampling frame. OBJECTIVE To determine the effectiveness of two sampling strategies; repeat transrectal ultrasonography (TRUS)-biopsy and transperineal template prostate mapping (TPM) to detect and exclude lesions of ≥0.2 mL or ≥0.5 mL using computer simulation on reconstructed three-dimensional (3-D) computer models of radical whole-mount specimens., PATIENTS AND METHODS Computer simulation on reconstructed 3-D computer models of radical whole-mount specimens was used to evaluate the performance characteristics of repeat TRUS-biopsy and TPM to detect and exclude lesions of ≥0.2 mL or ≥0.5 mL., In all, 107 consecutive cases were analysed (1999-2001) with simulations repeated 500 times for each biopsy strategy., TPM and five different TRUS-biopsy strategies were simulated; the latter involved a standard 12-core sampling and incorporated variable amounts of error, as well as the addition of anterior cores., Sensitivity, specificity, negative and positive predictive values for detection of lesions with a volume of ≥0.2 mL or ≥0.5 mL were calculated., RESULTS The mean ( sd) age and PSA concentration were 61 (6.4) years and 8.5 (5.9) ng/mL, respectively.In all, 53% (57/107) had low-intermediate risk disease., In all, 665 foci were reconstructed; there were 149 foci ≥0.2 mL and 97 ≥ 0.5 mL in the full cohort and 68 ≥ 0.2 mL and 43 ≥ 0.5 mL in the low-intermediate risk group., Overall, TPM accuracy (area under the receiver operating curve, AUC) was ≈0.90 compared with AUC 0.70-0.80 for TRUS-biopsy., In addition, at best, TRUS-biopsy missed 30-40% of lesions of ≥0.2 mL and ≥0.5 mL whilst TPM missed 5% of such lesions., CONCLUSION TPM under simulation conditions appears the most effective re-classification strategy, although augmented TRUS-biopsy techniques are better than standard TRUS-biopsy. [ABSTRACT FROM AUTHOR]

What's known on the subject? and What does the study add? Much of our understanding of the pathological basis of prostate cancer comes from our analysis of radical prostatectomy specimens. Prostate cancer diagnosed by transrectal ultrasonography-guided biopsy is more likely to be posterior and basal in orientation rather than anterior or apical. Quantitative tissue analyses have not been undertaken both with details and in an unselected population, e.g. prostate specimens from autopsy cystoprostatectomy series from bladder cancer. Quantitative tissue analysis of incidentally detected prostate cancer such as largest cancer surface area, volume, site of origin, multifocality and laterality could be of paramount importance when trying to understand the findings of screen-detected programmes and focal therapy. Cancers were found in 30% of prostates. In the 96 prostates, 215 cancer foci were identified (mean 2.24). Prostate cancer was multifocal in 60% and bilateral in 80% of cases. The site of origin was in the peripheral and transition zone (TZ) in 75% and 25%, respectively. Overall, 90% of cancer foci were clinically insignificant with volume of <0.5 mL and no grades 4-5. In all, 75% of the cancer foci were in the peripheral zone, the remainder were within the TZ. One third of cancer foci were anteriorly located beyond the area sampled by posterior biopsies. One fifth of cancer foci were ≤6 mm of the apex. OBJECTIVE To describe multifocality, volume and location of prostate cancers incidentally found in cystoprostatectomy specimens. Quantitative tissue analysis of prostate cancer in a population free of the evaluation bias associated with prostate-specific antigen level and biopsy is important as some men are likely to be offered tissue-preserving therapeutic strategies in the future., PATIENTS AND METHODS Cystoprostatectomy specimens for bladder cancer from 345 consecutive patients without clinically manifest prostate cancer were included., Cancers were found in 104/345 (30%) of prostates. Cases with largest cancer >2 mL (eight patients) were excluded from morphometric study. Quantitative tissue analysis of 3-mm step-sectioned glands included largest cancer surface area, volume, site of origin, multifocality and laterality., RESULTS In the 96 prostates, 215 cancer foci were identified (mean 2.24). Prostate cancer was multifocal in 58% and bilateral in 79% of cases., Of the 215 cancers, 90% were <0.5 mL and 79% <0.2 mL. Overall, 88% of cancer foci were clinically insignificant with a volume of <0.5 mL and no grades 4-5., In all, 75% of the cancer foci were in the peripheral zone, the remainder were within the transition zone., One third of cancer foci were anteriorly located beyond the area sampled by posterior biopsies. One fifth of cancer foci were ≤6 mm of the apex., Limitations include the fact that cystoprostatectomy cancer foci are at an earlier stage than screened-detected cancers., CONCLUSION This detailed morphometric analysis of prostate cancer foci in a population that is free from the selection bias associated with screening can help inform our diagnostic and treatment strategies. [ABSTRACT FROM AUTHOR]

What's known on the subject? and What does the study add? Whole gland brachytherapy has been used to successfully treat prostate cancer but the protocol for focal therapy has not previously been established. The consensus findings provide guidance on patient selection for focal brachytherapy as well as recommendations for conducting therapy and patient follow-up. Low dose rate prostate brachytherapy is an effective treatment for localized prostate cancer. Recently, it has been considered for use in a focused manner whereby treatment is targeted only to areas of prostate cancer. The objective of focal brachytherapy is to provide effective cancer control for low-risk disease but with reduced genitourinary and rectal side-effects in a cost-effective way. We report on the outputs of a consensus meeting of international experts in brachytherapy and focal therapy convened to consider the feasibility and potential development of focal brachytherapy. A number of factors were considered for focal brachytherapy including optimal patient selection, disease characterization and localization, treatment protocols and outcome measures. The consensus meeting also addressed the design of a clinical trial that would assess the oncological outcomes and side-effect profiles resulting from focal brachytherapy. [ABSTRACT FROM AUTHOR]

OBJECTIVE To determine the pathological characteristics of radical prostatectomy specimens with respect to index and secondary lesions. METHODS A total of 100 consecutive radical prostatectomy specimens examined at a single hospital were assessed. Patients undergoing salvage prostatectomy or those who had received neoadjuvant hormonal manipulation were excluded. Preoperative data and the number, volume and Gleason grade of each tumour focus were recorded. Criteria used to define a clinically significant lesion were tumour volume ≥ 0.5 mL and/or Gleason pattern 4 or 5 and/or extra-capsular disease. RESULTS Overall, 374 foci were examined. The median number of tumours per patient was 3.5 (range 1-15). The overall median tumour volume was 1.4 mL (range 0.1-18.2), the median volume of the largest (index) tumour was 0.95 mL (range 0.1-18.2) and the median volume of the largest secondary tumour was 0.2 mL (range 0.05-1.7). There were no patients in whom the index lesion was insignificant and secondary tumours were significant (by grade or extra-capsular disease). Seventy-seven fulfilled the clinical parameters of low-to-intermediate-risk disease. If focal therapy can be delivered with the aim of ablating all clinically significant disease, with untreated areas harbouring no cancer or clinically insignificant disease, between 58.5 and 67.5% might have been suitable for such a strategy. CONCLUSIONS The proportion of men with low-to-intermediate-risk prostate cancer who may potentially be suitable for a focal therapy approach is unknown. The key question is whether the volume of individual lesions points to clinically significant cancer and whether ablation of these lesions alone would lead to cancer control. This research question is currently undergoing evaluation within a prospective clinical trial. [ABSTRACT FROM AUTHOR]

OBJECTIVE To assess the role of multiparametric magnetic resonance imaging (mp-MRI) of the prostate in evaluating local recurrence of prostate cancer, using transperineal template-guided 5 mm-spaced biopsies as a reference standard, in men treated with external beam radiotherapy (EBRT) for prostate cancer. PATIENTS AND METHODS The study included 13 patients with evidence of biochemical recurrence after EBRT who had undergone mp-MRI and prostate mapping. Each MRI scan (consisting of T1/T2 weighting, dynamic contrast enhancement and diffusion weighting) was reported by two expert uro-radiologists. Each prostate was divided into four regions of interest (ROI), generating 52 paired datasets for analysis. RESULTS The mean (range) age of the men was 65.5 (55-70) years, the mean prostate-specific antigen (PSA) level before EBRT was 36.6 (4.5-150) ng/mL, the mean time from EBRT to biochemical recurrence was 5.7 (3-10) years and the mean PSA level at the time of recurrence was 7.1 (0.83-27.9) ng/mL. Eleven men had histological evidence of recurrence, with 23 of 52 ROIs involved with cancer. Overall accuracy, as expressed by the area under a receiver-operator curve, was 0.77 and 0.89 for all cancer, with accuracies of 0.86 and 0.93 for those cancers with ≥3 mm biopsy core length. Inter-observer variability was measured by calculating κ coefficients, which showed fair and moderate agreement between radiologists. CONCLUSIONS Interpretation of mpMRI of the prostate after previous EBRT is challenging. Our results show that the accuracy is good using an accurate reference standard. These results need verification in more patients, but have implications for determining presence or absence of local recurrence and subsequent local salvage therapy. [ABSTRACT FROM AUTHOR]

OBJECTIVES To investigate the use of minimally invasive high-intensity focused ultrasound (HIFU) as a salvage therapy in men with localized prostate cancer recurrence following external beam radiotherapy (EBRT). PATIENTS AND METHODS A review of 31 cases treated using the Sonablate® 500 HIFU device, between 1 February 2005 and 15 May 2007, was carried out. All men had presumed organ-confined, histologically confirmed recurrent prostate adenocarcinoma following EBRT. RESULTS The mean (range) age was 65 (57–80) years with a mean preoperative PSA level of 7.73 (0.20–20) ng/mL. The patients were followed for a mean (range) of 7.4 (3–24) months. Side-effects included stricture or intervention for necrotic tissue in 11 of the 31 patients (36%), urinary tract infection or dysuria syndrome in eight (26%), and urinary incontinence in two (7%). Recto-urethral fistula occurred in two men, although one was due to patient movement due to inadequate anaesthesia, so the ‘true’ rate is 3%. Half of the patients had PSA levels of <0.2 ng/mL at the last follow-up. Three patients had metastatic disease whilst another two had only local, histologically confirmed, failure. A further four patients had evidence of biochemical failure only. Overall, 71% had no evidence of disease following salvage HIFU. CONCLUSIONS Salvage HIFU is a minimally invasive daycase procedure that can achieve low PSA nadirs and good cancer control in the short term, with comparable morbidity to other forms of salvage treatment. The issue of accurate staging at the time of recurrence is still problematic, as a proportion of these men will harbour microscopic metastases undetected by conventional staging investigations. [ABSTRACT FROM AUTHOR]