Natural language processing pipeline to extract prostate cancer-related information from clinical notes.

OBJECTIVES: To develop an automated pipeline for extracting prostate cancer-related information from clinical notes. MATERIALS AND METHODS: This retrospective study included 23,225 patients who underwent prostate MRI between 2017 and 2022. Cancer risk factors (family history of cancer and digital rectal exam findings), pre-MRI prostate pathology, and treatment history of prostate cancer were extracted from free-text clinical notes in English as binary or multi-class classification tasks. Any sentence containing pre-defined keywords was extracted from clinical notes within one year before the MRI. After manually creating sentence-level datasets with ground truth, Bidirectional Encoder Representations from Transformers (BERT)-based sentence-level models were fine-tuned using the extracted sentence as input and the category as output. The patient-level output was determined by compilation of multiple sentence-level outputs using tree-based models. Sentence-level classification performance was evaluated using the area under the receiver operating characteristic curve (AUC) on 15% of the sentence-level dataset (sentence-level test set). The patient-level classification performance was evaluated on the patient-level test set created by radiologists by reviewing the clinical notes of 603 patients. Accuracy and sensitivity were compared between the pipeline and radiologists. RESULTS: Sentence-level AUCs were ≥ 0.94. The pipeline showed higher patient-level sensitivity for extracting cancer risk factors (e.g., family history of prostate cancer, 96.5% vs. 77.9%, p < 0.001), but lower accuracy in classifying pre-MRI prostate pathology (92.5% vs. 95.9%, p = 0.002) and treatment history of prostate cancer (95.5% vs. 97.7%, p = 0.03) than radiologists, respectively. CONCLUSION: The proposed pipeline showed promising performance, especially for extracting cancer risk factors from patient's clinical notes. CLINICAL RELEVANCE STATEMENT: The natural language processing pipeline showed a higher sensitivity for extracting prostate cancer risk factors than radiologists and may help efficiently gather relevant text information when interpreting prostate MRI. KEY POINTS: When interpreting prostate MRI, it is necessary to extract prostate cancer-related information from clinical notes. This pipeline extracted the presence of prostate cancer risk factors with higher sensitivity than radiologists. Natural language processing may help radiologists efficiently gather relevant prostate cancer-related text information.

MRI-guided Cryoablation of Prostate Cancer Lymph Node Metastasis.

PURPOSE: To evaluate the safety and effectiveness of MRI-guided cryoablation of prostate cancer metastatic lymph nodes(LN). MATERIALS AND METHODS: Fifty-two patients with prostate cancer who underwent MRI guided lymph node (LN) ablation from September 2013 to June 2022 were retrospectively reviewed. Of these, 6 patients were excluded because adequate ablation margins (3-5mm) could not be achieved secondary to adjacent structures. The remaining 46 patients (mean age, 70±7 years) underwent 55 MRI-guided cryoablation procedures of metastatic LN (25 in pelvic side wall, 20 within pelvic region and 10 in the abdomen) with procedural intent of complete ablation. Locoregional tumor control (i.e. technical success in the target LN) was evaluated on initial follow-up PET scans at mean of 4±2 months. Pre- and post-ablation prostate specific antigen (PSA) levels were recorded. Imaging follow-up continued until a median of 27.5 months (3-108 months). RESULTS: Ninety-five percent (52/55) of treated LN demonstrated no considerable activity on PET scans at initial follow-up at 4±2 months. PSA decreased to undetectable level of <0.1ng/mL after cryoablation in 14/46 patients (30.4%) with corresponding lack of activity in 13/46 (28.2%) patients on continued PET imaging follow-up. Only 6/55 (10.9%) patients had transient adverse events which all resolved with no long term sequalae. CONCLUSIONS: MRI-guided percutaneous cryoablation of metastatic LN is a safe and technically effective technique for treating metastatic prostate cancer in LN.

Decreased prostate MRI cancer detection rate due to moderate to severe susceptibility artifacts from hip prosthesis.

OBJECTIVES: To evaluate the impact of susceptibility artifacts from hip prosthesis on cancer detection rate (CDR) in prostate MRI. MATERIALS AND METHODS: This three-center retrospective study included prostate MRI studies for patients without known prostate cancer between 2017 and 2021. Exams with hip prosthesis were searched on MRI reports. The degree of susceptibility artifact on diffusion-weighted images was retrospectively categorized into mild, moderate, and severe (> 66%, 33-66%, and < 33% of the prostate volume are evaluable) by blind reviewers. CDR was defined as the number of exams with Gleason score ≥7 detected by MRI (PI-RADS ≥3) divided by the total number of exams. For each artifact grade, control exams without hip prosthesis were matched (1:6 match), and CDR was compared. The degree of CDR reduction was evaluated with ratio, and influential factors were evaluated by expanding the equation. RESULTS: Hip arthroplasty was present in 548 (4.8%) of the 11,319 MRI exams. CDR of the cases and matched control exams for each artifact grade were as follows: mild (n = 238), 0.27 vs 0.25, CDR ratio = 1.09 [95% CI: 0.87-1.37]; moderate (n = 143), 0.18 vs 0.27, CDR ratio = 0.67 [95% CI: 0.46-0.96]; severe (n = 167), 0.22 vs 0.28, CDR ratio = 0.80 [95% CI: 0.59-1.08]. When moderate and severe artifact grades were combined, CDR ratio was 0.74 [95% CI: 0.58-0.93]. CDR reduction was mostly attributed to the increased frequency of PI-RADS 1-2. CONCLUSION: With moderate to severe susceptibility artifacts from hip prosthesis, CDR was decreased to 74% compared to the matched control. CLINICAL RELEVANCE STATEMENT: Moderate to severe susceptibility artifacts from hip prosthesis may cause a non-negligible CDR reduction in prostate MRI. Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 was assigned. KEY POINTS: • We proposed cancer detection rate as a diagnostic performance metric in prostate MRI. • With moderate to severe susceptibility artifacts secondary to hip arthroplasty, cancer detection rate decreased to 74% compared to the matched control. • Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 is assigned.

Initial Psychometric Properties of 7 NeuroUX Remote Ecological Momentary Cognitive Tests Among People With Bipolar Disorder: Validation Study.

BACKGROUND: As smartphone technology has become nearly ubiquitous, there is a growing body of literature suggesting that ecological momentary cognitive testing (EMCT) offers advantages over traditional pen-and-paper psychological assessment. We introduce a newly developed platform for the self-administration of cognitive tests in ecologically valid ways. OBJECTIVE: The aim of this study is to develop a Health Insurance Portability and Accountability Act-compliant EMCT smartphone-based platform for the frequent and repeated testing of cognitive abilities in everyday life. This study examines the psychometric properties of 7 mobile cognitive tests covering domains of processing speed, visual working memory, recognition memory, and response inhibition within our platform among persons with and without bipolar disorder (BD). Ultimately, if shown to have adequate psychometric properties, EMCTs may be useful in research on BD and other neurological and psychiatric illnesses. METHODS: A total of 45 persons with BD and 21 demographically comparable healthy volunteer participants (aged 18-65 years) completed smartphone-based EMCTs 3 times daily for 14 days. Each EMCT session lasted approximately 1.5 minutes. Only 2 to 3 tests were administered in any given session, no test was administered more than once per day, and alternate test versions were administered in each session. RESULTS: The mean adherence to the EMCT protocol was 69.7% (SD 20.5%), resulting in 3965 valid and complete tests across the full sample. Participants were significantly more likely to miss tests on later versus earlier study days. Adherence did not differ by diagnostic status, suggesting that BD does not interfere with EMCT participation. In most tests, age and education were related to EMCT performance in expected directions. The average performances on most EMCTs were moderately to strongly correlated with the National Institutes of Health Toolbox Cognition Battery. Practice effects were observed in 5 tests, with significant differences in practice effects by BD status in 3 tests. CONCLUSIONS: Although additional reliability and validity data are needed, this study provides initial psychometric support for EMCTs in the assessment of cognitive performance in real-world contexts in BD.

Salvage ablation for locally recurrent prostate cancer.

PURPOSE OF REVIEW: This review aims to summarize the latest evidence for the use of salvage ablation of localized prostate cancer recurrences after primary therapy radiotherapy or prostatectomy. RECENT FINDINGS: Savage ablation represents a treatment option in select patients with localized recurrences following primary therapy of prostate cancer. Following radiotherapy, salvage cryotherapy and high-intensity focused ultrasound (HIFU) demonstrate encouraging oncologic outcomes. Biochemical recurrence-free survival ranged from 71% at 2 years to 44.2% at 10 years for cryotherapy and from 51% at 5 years to 28.7% at 10 years for HIFU. Rates of adverse effects appear to be more favorable with ablation compared to salvage surgery. Focal salvage ablation may offer a further balance between oncologic control and adverse effects. Following radical prostatectomy, recent data on the use of salvage ablation of local recurrences are less robust with only a few small studies published in the last 2 years. SUMMARY: Salvage ablation is an option for localized disease recurrences following primary treatment. Its role is most established for postradiation recurrence. It can also be utilized in postprostatectomy recurrence, although published data is more limited. Future studies are needed to further explore the role of ablation in both cohorts.

Ectopic Penile Prosthesis Reservoir Placement: An Anatomic Cadaver Model of the High Submuscular Technique.

INTRODUCTION: High submuscular ectopic placement of inflatable penile prosthesis (IPP) reservoirs via the inguinal canal has been popularized as an alternative to the retropubic (orthotopic) location, particularly among men with prior pelvic surgery. Published results suggest minimal complications and high patient satisfaction. However, in our practice, we identified several patients presenting for IPP revision after high submuscular placement who were found to have reservoirs within the peritoneal cavity. AIM: Given the potential for complications, we performed a cadaveric study to define the anatomic location of reservoirs placed using this technique. METHODS: We utilized 10 fresh male cadavers without embalming. Bilateral ectopic reservoir placement (10 AMS Conceal [Boston Scientific, Marlborough, MA] and 10 Coloplast Cloverleaf [Coloplast Corp, Humlebaek, Denmark]) was performed using the high submuscular technique via a penoscrotal incision. Strict adherence to published reports detailing the technique was emphasized to assure reliability of findings. MAIN OUTCOME MEASURES: Anatomic dissection was performed to identify reservoir location within the abdominal wall layers. RESULTS: Twenty IPP reservoirs were placed without difficulty or concern for inadvertent malpositioning. Sixteen reservoirs (80%) were found anterior to the transversalis fascia, including 7 (35%) deep to the rectus muscle and 9 (45%) deep to the external oblique fascia and lateral to the rectus muscle belly. Two reservoirs (10%) were identified in the retroperitoneal space, while 1 (5%) was preperitoneal (deep to transversalis fascia) and 1 (5%) was intraperitoneal. CONCLUSION: Placement of IPP reservoirs using the high submuscular technique results in variable anatomic locations, including within or immediately superficial to the peritoneal cavity. Given the lack of immediate recognition and risk of delayed complications with suboptimal reservoir placement, further studies are mandated to assess the long-term safety of the technique.

Developing the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia program.

INTRODUCTION: With Alzheimer's disease and related dementias (ADRD) representing an enormous public health challenge, there is a need to support individuals in learning about and addressing their modifiable risk factors (e.g., diet, sleep, and physical activity) to prevent or delay dementia onset. However, there is limited availability for evidence-informed tools that deliver both quality education and support for positive behavior change such as by increasing self-efficacy and personalizing goal setting. Tools that address the needs of Latino/a, at higher risk for ADRD, are even more scarce. METHODS: We established a multidisciplinary team to develop the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia (HALT-AD) program, a bilingual online personalized platform to educate and motivate participants to modify their risk factors for dementia. Grounded in social cognitive theory and following a cultural adaptation framework with guidance from a community advisory board, we developed HALT-AD iteratively through several cycles of rapid prototype development, user-centered evaluation through pilot testing and community feedback, and refinement. RESULTS: Using this iterative approach allowed for more than 100 improvements in the content, features, and design of HALT-AD to improve the program's usability and alignment with the interests and educational/behavior change support needs of its target audience. Illustrative examples of how pilot data and community feedback informed improvements are provided. DISCUSSION: Developing HALT-AD iteratively required learning through trial and error and flexibility in workflows, contrary to traditional program development methods that rely on rigid, pre-set requirements. In addition to efficacy trials, studies are needed to identify mechanisms for effective behavior change, which might be culturally specific. Flexible and personalized educational offerings are likely to be important in modifying risk trajectories in ADRD.

Cancer Detection Rate and Abnormal Interpretation Rate of Prostate MRI Performed for Clinical Suspicion of Prostate Cancer.

PURPOSE: To report cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI performed for clinical suspicion of prostate cancer (PCa). MATERIALS AND METHODS: This retrospective single-institution, three-center study included patients who underwent MRI for clinical suspicion of PCa between 2017 and 2021. Patients with known PCa were excluded. Patient-level Prostate Imaging-Reporting and Data System (PI-RADS) score was extracted from the radiology report. AIR was defined as number of abnormal MRI (PI-RADS score 3-5) / total number of MRIs. CDR was defined as number of clinically significant PCa (csPCa: Gleason score ≥7) detected at abnormal MRI / total number of MRI. AIR, CDR, and CDR adjusted for pathology confirmation rate were calculated for each of three centers and pre-MRI biopsy status (biopsy-naive and previous negative biopsy). RESULTS: A total of 9,686 examinations (8,643 unique patients) were included. AIR, CDR, and CDR adjusted for pathology confirmation rate were 45.4%, 23.8%, and 27.6% for center I; 47.2%, 20.0%, and 22.8% for center II; and 42.3%, 27.2%, and 30.1% for center III, respectively. Pathology confirmation rate ranged from 81.6% to 88.0% across three centers. AIR and CDR for biopsy-naive patients were 45.5% to 52.6% and 24.2% to 33.5% across three centers, respectively, and those for previous negative biopsy were 27.2% to 39.8% and 11.7% to 14.2% across three centers, respectively. CONCLUSION: We reported CDR and AIR in prostate MRI for clinical suspicion of PCa. CDR needs to be adjusted for pathology confirmation rate and pre-MRI biopsy status for interfacility comparison.

Cancer Detection Rate and Abnormal Interpretation Rate of Prostate MRI in Patients With Low-Grade Cancer.

PURPOSE: The aim of this study was to evaluate the utility of cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI for patients with low-grade prostate cancer (PCa). METHODS: This three-center retrospective study included patients who underwent prostate MRI from 2017 to 2021 with known low-grade PCa (Gleason score 6) without prior treatment. Patient-level highest Prostate Imaging Reporting & Data System (PI-RADS®) score and pathologic diagnosis within 1 year after MRI were used to evaluate the diagnostic performance of prostate MRI in detecting clinically significant PCa (csPCa; Gleason score ≥ 7). The metrics AIR, CDR, and CDR adjusted for pathologic confirmation rate were calculated. Radiologist-level AIR-CDR plots were shown. Simulation AIR-CDR lines were created to assess the effects of different diagnostic performances of prostate MRI and the prevalence of csPCa. RESULTS: A total of 3,207 examinations were interpreted by 33 radiologists. Overall AIR, CDR, and CDR adjusted for pathologic confirmation rate at PI-RADS 3 to 5 (PI-RADS 4 and 5) were 51.7% (36.5%), 22.1% (18.8%), and 30.7% (24.6%), respectively. Radiologist-level AIR and CDR at PI-RADS 3 to 5 (PI-RADS 4 and 5) were in the 36.8% to 75.6% (21.9%-57.5%) range and the 16.3%-28.7% (10.9%-26.5%) range, respectively. In the simulation, changing parameters of diagnostic performance or csPCa prevalence shifted the AIR-CDR line. CONCLUSIONS: The authors propose CDR and AIR as performance metrics in prostate MRI and report reference performance values in patients with known low-grade PCa. There was variability in radiologist-level AIR and CDR. Combined use of AIR and CDR could provide meaningful feedback for radiologists to improve their performance by showing relative performance to other radiologists.

Automated surgical step recognition in transurethral bladder tumor resection using artificial intelligence: transfer learning across surgical modalities.

Objective: Automated surgical step recognition (SSR) using AI has been a catalyst in the "digitization" of surgery. However, progress has been limited to laparoscopy, with relatively few SSR tools in endoscopic surgery. This study aimed to create a SSR model for transurethral resection of bladder tumors (TURBT), leveraging a novel application of transfer learning to reduce video dataset requirements. Materials and methods: Retrospective surgical videos of TURBT were manually annotated with the following steps of surgery: primary endoscopic evaluation, resection of bladder tumor, and surface coagulation. Manually annotated videos were then utilized to train a novel AI computer vision algorithm to perform automated video annotation of TURBT surgical video, utilizing a transfer-learning technique to pre-train on laparoscopic procedures. Accuracy of AI SSR was determined by comparison to human annotations as the reference standard. Results: A total of 300 full-length TURBT videos (median 23.96 min; IQR 14.13-41.31 min) were manually annotated with sequential steps of surgery. One hundred and seventy-nine videos served as a training dataset for algorithm development, 44 for internal validation, and 77 as a separate test cohort for evaluating algorithm accuracy. Overall accuracy of AI video analysis was 89.6%. Model accuracy was highest for the primary endoscopic evaluation step (98.2%) and lowest for the surface coagulation step (82.7%). Conclusion: We developed a fully automated computer vision algorithm for high-accuracy annotation of TURBT surgical videos. This represents the first application of transfer-learning from laparoscopy-based computer vision models into surgical endoscopy, demonstrating the promise of this approach in adapting to new procedure types.

A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial.

The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Primary Whole-gland Ablation for the Treatment of Clinically Localized Prostate Cancer: A Focal Therapy Society Best Practice Statement.

CONTEXT: Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. OBJECTIVE: To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. EVIDENCE ACQUISITION: We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. EVIDENCE SYNTHESIS: Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. CONCLUSIONS: The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. PATIENT SUMMARY: Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.

A framework for designing AI systems that support community wellbeing.

Introduction: Designing artificial intelligence (AI) to support health and wellbeing is an important and broad challenge for technologists, designers, and policymakers. Drawing upon theories of AI and cybernetics, this article offers a design framework for designing intelligent systems to optimize human wellbeing. We focus on the production of wellbeing information feedback loops in complex community settings, and discuss the case study of My Wellness Check, an intelligent system designed to support the mental health and wellbeing needs of university students and staff during the COVID-19 pandemic. Methods: The basis for our discussion is the community-led design of My Wellness Check, an intelligent system that supported the mental health and wellbeing needs of university students and staff during the COVID-19 pandemic. Our system was designed to create an intelligent feedback loop to assess community wellbeing needs and to inform community action. This article provides an overview of our longitudinal assessment of students and staff wellbeing (n = 20,311) across two years of the COVID-19 pandemic. Results: We further share the results of a controlled experiment (n = 1,719) demonstrating the enhanced sensitivity and user experience of our context-sensitive wellbeing assessment. Discussion: Our approach to designing "AI for community wellbeing," may generalize to the systematic improvement of human wellbeing in other human-computer systems for large-scale governance (e.g., schools, businesses, NGOs, platforms). The two main contributions are: 1) showcasing a simple way to draw from AI theory to produce more intelligent human systems, and 2) introducing a human-centered, community-led approach that may be beneficial to the field of AI.

Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience.

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

Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi Consensus from the Focal Therapy Society.

BACKGROUND: Focal therapy (FT) for prostate cancer (PCa) is promising. However, long-term oncological results are awaited and there is no consensus on follow-up strategies. Molecular biomarkers (MB) may be useful in selecting, treating and following up men undergoing FT, though there is limited evidence in this field to guide practice. We aimed to conduct a consensus meeting, endorsed by the Focal Therapy Society, amongst a large group of experts, to understand the potential utility of MB in FT for localized PCa. METHODS: A 38-item questionnaire was built following a literature search. The authors then performed three rounds of a Delphi Consensus using DelphiManager, using the GRADE grid scoring system, followed by a face-to-face expert meeting. Three areas of interest were identified and covered concerning MB for FT, 1) the current/present role; 2) the potential/future role; 3) the recommended features for future studies. Consensus was defined using a 70% agreement threshold. RESULTS: Of 95 invited experts, 42 (44.2%) completed the three Delphi rounds. Twenty-four items reached a consensus and they were then approved at the meeting involving (N.=15) experts. Fourteen items reached a consensus on uncertainty, or they did not reach a consensus. They were re-discussed, resulting in a consensus (N.=3), a consensus on a partial agreement (N.=1), and a consensus on uncertainty (N.=10). A final list of statements were derived from the approved and discussed items, with the addition of three generated statements, to provide guidance regarding MB in the context of FT for localized PCa. Research efforts in this field should be considered a priority. CONCLUSIONS: The present study detailed an initial consensus on the use of MB in FT for PCa. This is until evidence becomes available on the subject.

ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI.

INTRODUCTION: The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI. METHODS AND ANALYSIS: The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50-75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer. ETHICS AND DISSEMINATION: ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London-Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04063566).

All change in the prostate cancer diagnostic pathway.

Following detection of high levels of serum prostate-specific antigen, many men are advised to have transrectal ultrasound-guided biopsy in an attempt to locate a cancer. This nontargeted approach lacks accuracy and carries a small risk of potentially life-threatening sepsis. Worse still, it can detect clinically insignificant cancer cells, which are unlikely to be the origin of advanced-stage disease. The detection of these indolent cancer cells has led to overdiagnosis, one of the major problems of contemporary medicine, whereby many men with clinically insignificant disease are advised to undergo unnecessary radical surgery or radiotherapy. Advances in imaging and biomarker discovery have led to a revolution in prostate cancer diagnosis, and nontargeted prostate biopsies should become obsolete. In this Perspective article, we describe the current diagnostic pathway for prostate cancer, which relies on nontargeted biopsies, and the problems linked to this pathway. We then discuss the utility of prebiopsy multiparametric MRI and novel tumour markers. Finally, we comment on how the incorporation of these advances into a new diagnostic pathway will affect the current risk-stratification system and explore future challenges.

Rectal wall saline displacement for improved margin during MRI-guided cryoablation of primary and recurrent prostate cancer.

PURPOSE: To describe safety, efficacy, and added oncologic margin of saline displacement of the rectal wall during MRI-guided cryoablation of primary and recurrent prostate cancer. METHODS: A retrospective review was conducted for patients who underwent MRI-guided cryoablation with saline displacement of the rectal wall for treatment of primary and recurrent prostate cancer over a 2-year period. Saline displacement was used when the distance from the edge of the ablation area to the rectal wall was insufficient to provide at least a 5-mm treatment margin. Pre- and post-ablation rectal wall displacement distances as well as ablative zone margins were assessed with MRI. Saline displacement distance was measured from the rectal wall to the edge of the lesion for focal lesion ablation and from the edge of the prostate for hemi-gland ablation. Immediate and intermediate-term complications were assessed. RESULTS: Saline displacement was used in 25 patients undergoing MRI-guided cryoablation. Twenty-one patients underwent salvage cryoablation, while four patients had it as primary treatment for prostate cancer. Median pre- and post- saline displacement rectal wall displacement distances were 6.0 and 11.2 mm, respectively (P < 0.0001). Median-added oncologic margin achieved by saline displacement was 4.6 mm (range 0.6-26.5). Median follow-up was 14 months (range 5-29). There were no intra-procedural complications and 3 patients experienced minor (Clavien-Dindo grade I) complications. One rectal complication occurred in a patient undergoing salvage cryotherapy with a history of extensive pelvic surgery and radiation. CONCLUSIONS: Saline infusion at the time of MRI- guided cryoablation for prostate cancer resulted in increased distances between the target lesion and rectum. This is a useful technique in providing an added oncologic margin when treating lesions close to the rectal wall.

How informed is our consent? Patient awareness of radiation and radical prostatectomy complications.

OBJECTIVE: To evaluate patient's recall of pretreatment counseling for radical prostatectomy and radiation therapy for the treatment of prostate cancer. MATERIAL AND METHODS: A retrospective review of all patients presenting to our reconstructive urology clinic for the management of the complications of prostate cancer treatment was conducted over 24 months. Patients treated with only surgery or radiotherapy were included in the study. Patients were asked a standard series of questions to assess their recall of their pre-prostate cancer treatment counseling. RESULTS: We identified 206 patients that met inclusion criteria. Of those, 153 underwent radical prostatectomy and 53 patients received radiation therapy. Median age at presentation was 72 years in the surgery group and 75 in the radiation therapy group. Mean time since treatment was 8.8 years in those that recalled being counseled and 9.9 years in those who did not (p=0.21). In the surgery group, the adverse effects experienced by 119 (77.8%) patients recalled, and counselled were related to the risk of treatment. In the surgical patients that had records with documentation of pretreatment counseling, 41/48 (85.4%) endorsed recall. In the surgery group, 117 (76.5%) stated that their treating physician was aware of their complication. In the radiation group, 5 patients (9.4%) endorsed recall (p<0.0001). In the subgroup of radiation patients with documentation of pre-treatment counseling, no patients endorsed recall. In the surgery group, 117 (76.5%) patients stated that their treating physicians were aware of their complication, while in the radiation group, only 16 (30.2%) of treating physicians were aware of the complications (p<0.0001). CONCLUSION: Patient recall of potential complications of prostate cancer treatment is poor. It's unclear if this is secondary to poor recall, selective memory loss or inadequate counseling.