Mobile cancer-testing services can widen access by taking testing to community or workplace sites. But the test is only one part of the pathway: eligibility explanation, informed choice, privacy, documentation, result communication, referral, and follow-up move outside clinics. Unless specified before rollout, these tasks can make a service easier to attend but harder to govern. In diagnostic-test development, a Target Product Profile is an advance brief defining a test’s intended users, use setting, and minimum and preferred features. To create an equivalent brief for outreach services, we adapted that approach into an implementation-aware Target Product Profile (iTPP). The iTPP turns evidence on delivery and handover into a requirement register, separating what must be in place, what would improve quality, what depends on local set-up, and what needs further evidence. We conducted a qualitative method-development study using the Man Van mobile prostate-specific antigen (PSA) testing pathway as an exemplar, not an effectiveness evaluation. We interviewed attenders (n = 23), planning and delivery stakeholders (n = 13), and prospective stakeholders (n = 11). Using the Framework Method and abductive analysis, we charted interview evidence, converted delivery and handover issues into requirement statements, judged consequences of absence, and placed unresolved quantitative or operational questions in an Evidence and Decision Agenda. The method produced a Man Van-derived register with 42 attributes across six clusters: outreach legitimacy; privacy and dignity; deliverability; test acceptability and performance uncertainty; counselling and next steps; and data integration with primary care. Handover requirements centred on result ownership, record integration, safety-netting, and loop closure: documented responsibility acceptance by a named receiving service when action was required. Diagnostic thresholds, referral ratios, staffing ratios, outreach pacing, unit costs, and equity effects were treated as questions for further evidence, not universal requirements. The iTPP is a pre-rollout method for specifying mobile outreach cancer-testing pathways before local adaptation, implementation, or evaluation. It identifies what should be preserved, what can vary by context, and what should remain open until stronger evidence is available. This PSA exemplar demonstrates the method; it does not establish service effectiveness, validate iTPP as an independent instrument, or recommend population screening.
The Man Van project is designed to address health inequalities and barriers to accessing healthcare related to the early diagnosis of prostate cancer with novel community-based targeting of high-risk groups using a mobile clinical unit. These inequalities are particularly relevant for men from ethnic minorities and lower socio-economic groups. We used a cost analysis with a micro-costing study to examine the costs of using the Man Van model for community-based prostate-specific antigen (PSA) testing compared with primary care-based PSA testing over the course of a 2-year period. The Man Van service has a nurse-led model with initial counselling carried out by band 8 (pilot) or 7 (phase 2) nurses assisted by a Band 4 care support worker. The Man Van operated in North and South-West London between 2021 and 2024. PSA counselling and blood testing were performed within the same appointment. PSA testing in primary care is performed by general practitioners with counselling followed by a phlebotomy appointment. In both primary care and the Man Van service, normal results are usually texted to patients with telephone calls for abnormal results. A micro-costing study and cost analysis was undertaken to compare costs of the primary care and Man Van models of PSA testing from the perspective of the National Health Service. Baseline staffing costs were approximated from data obtained from the Personal Social Services Research Unit based in the UK and include direct and indirect overheads. A micro-costing analysis showed costs per participant seen of £81.11 in the pilot phase of the Man Van, reducing by 33
Background and objective The surgical plan in robotic-assisted radical prostatectomy (RARP) aims to achieve optimal perioperative, oncological, and functional outcomes by recommending the extent of resection and use of function sparing techniques. However, there is a lack in high-level evidence on the optimal process to define the plan preoperatively. We therefore undertook a consensus exercise to develop the best practice statement to supplement evidence-based guidelines. Methods A consensus exercise was undertaken using a modified RAND/University of California Los Angeles approach. Consensus was a priori defined as ≥75% agreement/disagreement. A total of 101 statements were developed by the steering group based on a previously published systematic review and were reviewed in three rounds by 14 panellists. Key findings and limitations Overall, 73 statements reached consensus and 34 reached consensus across six domains. The process concluded that a preoperative surgical plan is essential prior to undertaking any RARP and will facilitate the optimal execution of surgery, as it provides the best available information to the surgeon to refine the technique and potentially improve oncological, functional, and perioperative outcomes. Conclusions and clinical implications The consensus statements draw out the best practices in the surgical planning process and can assist surgeons in standardising their approach. Gaps (areas of nonconsensus) have also been identified that can direct future work.
BackgroundPoint of care (POC) tests may improve accessibility and reduce costs of blood tests including in prostate cancer. The Man Van project was a pilot designed to address health inequalities that affect prostate cancer with novel community-based targeting of high-risk groups on a mobile clinical unit.MethodsThe i-CHROMA-II™ POC machine is a quantitative assay for the measurement of total prostate specific antigen (PSA) from capillary blood using fluorescence immunoassay technology. Laboratory based Serum PSA testing was compared with capillary blood POC testing using the i-CHROMA-II™ to determine its accuracy and impact on clinical decision making on the Man Van.Results28 men participated. The median age was 53 years (range 45-74). One POC test result was invalid. Nine POCT samples gave a result of <0.5 μg/L and were not included in the analysis. Of the remaining results (N = 18) the median PSA was 1.97 μg/L (range 0.54-31.22 μg/L). Using Lin's Concordance Correlation Coefficient of Absolute Agreement gave a value of 0.392 (N = 17). A Bland-Altman plot showed a mean difference of 0.377 μg/L.ConclusionsWe report the first testing of PSA using the i-Chroma-II™ machine, and the first real-world mobile testing using any POC PSA test. Our study did not show correlation between the laboratory and i-Chroma-II™, although it did replicate the positive bias seen in previous studies. Further testing and refinement of POC tests may help to achieve the goal to developing reliable POC PSA tests.
BACKGROUND:The incidence of prostate cancer is increasing. Screening with an assay of prostate-specific antigen (PSA) has a high rate for false positive results. Genomewide association studies have identified common germline variants in persons with prostate cancer, which can be used to calculate a polygenic risk score associated with risk of prostate cancer. METHODS:We recruited persons 55 to 69 years of age from primary care centers in the United Kingdom. Using germline DNA extracted from saliva, we derived polygenic risk scores from 130 variants known to be associated with an increased risk of prostate cancer. Participants with a polygenic risk score in the 90th percentile or higher were invited to undergo prostate cancer screening with multiparametric magnetic resonance imaging (MRI) and transperineal biopsy, irrespective of PSA level. RESULTS:Among 40,292 persons invited to participate, 8953 (22.2%) expressed interest in participating and 6393 had their polygenic risk score calculated; 745 (11.7%) had a polygenic risk score in the 90th percentile or higher and were invited to undergo screening. Of these 745 participants, 468 (62.8%) underwent MRI and prostate biopsy; prostate cancer was detected in 187 participants (40.0%). The median age at diagnosis was 64 years (range, 57 to 73). Of the 187 participants with cancer, 103 (55.1%) had prostate cancer classified as intermediate or higher risk according to the 2024 National Comprehensive Cancer Network (NCCN) criteria, so treatment was indicated; cancer would not have been detected in 74 (71.8%) of these participants according to the prostate cancer diagnostic pathway currently used in the United Kingdom (high PSA level and positive MRI results). In addition, 40 of the participants with cancer (21.4%) had disease classified as unfavorable intermediate risk or as high or very high risk according to NCCN criteria. CONCLUSIONS:In a prostate cancer screening program involving participants in the top decile of risk as determined by a polygenic risk score, the percentage found to have clinically significant disease was higher than the percentage that would have been identified with the use of PSA or MRI. (Funded by the European Research Council Seventh Framework Program and others; BARCODE1 ClinicalTrials.gov number, NCT03857477.).
317 Background: Early intervention is potentially lifesaving in prostate cancer and is a major limitation of cancer outcomes with ethnicity and deprivation being determinants of inequalities that impact outcomes. The Man Van is designed to address health inequalities and barriers to accessing healthcare that affect prostate cancer with novel community-based targeting of high-risk groups using a mobile clinical unit. These inequalities are particularly relevant for men from ethnic minorities and lower socio-economic groups. Methods: A bespoke nurse-led mobile clinical unit was moved to community-based locations in areas of high deprivation indices in London (UK) with targeted invitations to high-risk men. Men were offered prostate-specific antigen (PSA) tests and a general health check including: blood pressure, body mass index and an HbA1c test for diabetes. Results: Between January 2023 and January 2024, 3379 men attended a Man Van clinic (non-attendance rate 15.1%). The median age of attendees was 59 years (range 39-97). 36.4% of attendees were non-White including 16.7% of men who were Black. The median IMD rank was within the 6 th lowest decile. 310 men were referred for prostate cancer investigations, 262 had prostate MRI scans. 139 (53.1%) of MRIs were PIRADS 1/2, 35 (13.4%) PIRADS 3, 85 (32.4%) were PIRADS 4/5. 3 (1.1%) scans could not be scored. 127 patients underwent a prostate biopsy (48.5% of men having an MRI scan), with 94 prostate cancers diagnosed (74.0% of biopsies). 81 (86.2%) of these were cancers with clinically significant disease, being grade group 2 (i.e. Gleason 7) or higher (all with >5% pattern 4 Gleason scores). The overall diagnostic rate of clinically significant disease was 2.8%. No prostate cancers were metastatic at presentation, with only one being T4. Of the men diagnosed with prostate cancer (N=94), 25 (26.6%) were managed with active surveillance, 2 (2.1%) were managed with cryotherapy, 2 (2.1%) were managed with low dose-rate brachytherapy, 39 (41.5%) underwent robotic prostatectomy and 26 (27.7%) underwent radiotherapy. 59 patients were referred on two week wait pathways for haematuria (visible or persistent non-visible). One bladder cancer (TCC) was diagnosed (G3pT1bN0M1). 43 patients (2%) were diagnosed with diabetes, 207 patients (11%) with pre-diabetes. Conclusions: The Man Van initiative is a novel method of linking primary and secondary care for a range of health checks, including PSA. With a streamlined and more efficient service we have maintained high uptakes for health checks a willingness to engage with health improvement measures from deprived and ethnic minority groups. As well as comparatively high levels of prostate cancers diagnosed at early stages, high levels of other health conditions were found; improving the economic value of the service. Clinical trial information: NCT06357416 .
BACKGROUND:Prostate specific antigen density (PSAd) is one of the strongest predictors of clinically-significant prostate cancer (csPCa) in risk calculators. There is little evidence on the effect of prostate volume on the diagnostic performance of PSAd. Our aim was to define the diagnostic accuracy of PSAd for predicting csPCa across prostate volumes. METHODS:548 patients who underwent magnetic resonance imaging (MRI) and biopsy were included in this retrospective study. Patients were grouped by prostate volume; small (≤ 30 mL), medium (> 30 to < 50 mL), large (≥ 50 mL). Sensitivity and specificity of PSAd were assessed at thresholds of ≥ 0.10, ≥ 0.15, and ≥ 0.20 ng/mL/mL for two definitions of csPCa. RESULTS:At all PSAd thresholds and for both definitions of csPCa, there was a statistically significant and clinically-relevant difference in diagnostic performance across prostate volume groups. Sensitivity was highest in small glands, lowest in large glands; the opposite being true for specificity. Using a PSAd threshold of ≥ 0.15 ng/mL/mL, sensitivity for ISUP grade ≥ 2 PCa was 83.1%, 63.6%, and 33.3% for small, medium and large prostates (p ≤ 0.001) with specificities of 48.5%, 67.5% and 79.3%, respectively (p = 0.005). CONCLUSIONS:Diagnostic performance of PSAd varied significantly by prostate volume, and by applying a single PSAd threshold across all prostate volumes risks missing csPCa in men with larger glands, whilst performing unnecessary biopsies in those with smaller glands. Defining PSAd thresholds according to prostate volume categories can therefore improve its use as a risk predictor for csPCa.
INTRODUCTION:Prostate cancer, the most common male cancer in the United Kingdom, disproportionately affects Black men and deprived communities, where early diagnosis is critical to reducing mortality. The Man Van, a mobile outreach service, targets these high-risk groups to improve access to prostate cancer testing. The Man Van was developed to address health inequalities and other barriers to healthcare that affect prostate cancer and men's health more generally. As a novel clinical model, measuring the patients' perspectives of its quality and acceptability is relevant when evaluating its effectiveness. METHODS:To facilitate evaluation of the effectiveness of the Man Van project, a novel patient questionnaire was developed using a three-stage approach: (1) identification of domains and evaluation of existing evidence, (2) discussion groups followed by a modified virtual Delphi approach to refine themes and develop questions and (3) a real-world evaluation to finalise the questionnaire. Virtual discussions and asynchronous feedback facilitated stakeholder input. RESULTS:Two broad areas of acceptability and quality were identified, which were synthesised into 9 domains, linked to 15 themes to measure patients' perspectives on the Man Van. The final 17-item questionnaire follows the patient journey from service awareness to discharge, with socio-demographic data sourced from the Man Van database. CONCLUSIONS:This study produced the first evidence-based questionnaire for evaluating a mobile prostate cancer outreach service, highlighting that a well-defined service with good communication is key to establishing and maintaining quality and acceptability with patients. The tool offers a framework for evaluating and scaling similar interventions, which can be used by policymakers as a foundation for scaling up similar services.
e13511 Background: Expanding prescriber bases is essential for more equitable and holistic healthcare, particularly amid the global healthcare workforce crisis. In oncology, healthcare professionals are experiencing increasing workloads due to therapeutic advances and improved patient survival requiring multiple lines of therapy. This scoping review aims to identify benefits and challenges associated with expanding prescriber bases, particularly for oncology and prostate cancer. Methods: A targeted literature review was performed on PubMed to identify relevant articles published between 2019–2024, with additional information sourced from grey literature. Articles were screened against predefined research questions, with data extracted on the benefits, barriers, challenges, and unmet educational needs when expanding a prescriber base. Results: Overall, 51 studies were included. Benefits of expanding prescriber bases included increased professional autonomy, widening skillsets, enhanced job satisfaction, and improved resource allocation. However, a lack of education/training was identified, particularly around guideline adherence, foundational understanding of concepts (e.g., mechanisms of action), and interpretation of efficacy/safety data. Online resources could help reduce reliance on mentors/supervisors and facilitate ongoingeducation and training. In prostate cancer, the growing availability of systemic anticancer therapies (SACT) allows more patients to receive treatment and offers more treatment options for individual patients. Expanding the prescriber base for SACT is required to meet this demand. Several SACT training options were identified including subspecialty accreditation, university accredited courses and online learning modules. Conclusions: Better training programs are critical to ensure healthcare professionals can safely and effectively prescribe treatments, giving patients fair access to the care they need.
Summary Incontinence and Erectile-Dysfunction (ED) is a reality for many men post-Radical Prostatectomy. Urologists undertaking this procedure should prioritize minimizing postoperative incontinence and sexual dysfunctions. One major obstacle in the rehabilitation process is the lack of a standardized, objective, universal definition to accurately define post-operative incontinence and ED. This makes it challenging to tailor treatment, manage expectations, and also monitor progress in patients who suffer from post-RP incontinence and ED. Nevertheless, treatment always remains undoubtedly superior to leaving the issues without intervention. This chapter describes in details about the complete rehabilitation process to be followed in each and every patient undergoing Radical Prostatectomy.
Purpose: To assess concordance of radiological and pathological staging in patients undergoing radical robot-assisted laparoscopic prostatectomy (RALP) [1].
AbstractObjectivesTo understand whether bladder outflow obstruction influences the association between traditional clinical predictive factors, particularly prostate‐specific antigen (PSA) density and clinically significant prostate cancer (csPCa). This will help facilitate effective and evidence‐based triaging of patients in rapid‐access clinics.Materials and MethodsWe retrospectively analysed prospectively collected data from 307 suspected prostate cancer patients who underwent diagnostic biopsy from 2019 to 2023 at a single, high‐volume, specialist cancer centre. Uroflowmetry testing generated two cohorts: patients with bladder outflow obstruction and non‐obstructed patients. The cohort characteristics between the groups were compared and logistic regression analyses were performed to assess associations between clinical predictive factors (age, PSA density, ethnicity, family history, digital rectal examination, urinary symptom severity and magnetic resonance imaging using the PI‐RADS scoring system) and clinically significant prostate cancer (csPCa) on biopsy (defined as International Society of Urological Pathology grade of greater than or equal to two).ResultsThe obstructed group (n = 80) had significantly larger prostates and worse symptom severity (p < 0.05). There was no significant difference between the other predictive factors or csPCa compared to the non‐obstructed (n = 227) cohort. Multivariable logistic regression analysis showed age, PSA density, an abnormal digital rectal examination and scoring PI‐RADS 4–5 on magnetic resonance imaging were all significantly associated with csPCa in the non‐obstructed cohort (p < 0.05). Contrastingly, only symptom severity and scoring PI‐RADS 5 were significantly associated with csPCa for the obstructed patients (p < 0.05).ConclusionIn the presence of bladder outflow obstruction, traditional predictive variables such as age, PSA density, digital rectal examination and scoring PI‐RADS 4 are not associated with csPCa. This study suggests that using these predictive variables to triage patients in rapid‐access clinics with a patient who has bladder outflow obstruction could lead to the overuse of invasive biopsy.
10500 Background: Incidence of prostate cancer (PCa) is increasing, but there is no internationally agreed population screening program. Studies using an age-based PSA approach show a high rate of false-positive results as well as over-diagnosis of indolent PCa. Genome wide association studies identify common germline variants to calculate a polygenic risk score (PRS) associated with PCa risk. The BARCODE1 study used PRS to target PCa screening to those at higher risk based on genotype. Methods: European men aged 55-69yrs were recruited via Primary Care in the UK. PRS was constructed by summing weighted risk alleles for 130 PCa risk variants using germline DNA from saliva samples via mailed kits. Men with a PRS > 90th centile were invited for PCa screening using MRI and 12-core transperineal biopsy (including MRI fusion to target additional lesions where identified) irrespective of PSA result. Results: Invitation letters were sent to 40,292 men. 8,953 (22%) expressed an interest; 8,014 were eligible and sent a saliva kit. 6,644 consented; 6,393 were genotyped; 251 failed QC. A total of 6,142 participants had PRS calculated: 745 (12.1%) had a PRS > 90th centile and were invited to screening. 558/745 participants attended screening (121 declined, 66 excluded on health grounds). 551 underwent MRI and 468 had prostate biopsy resulting in 187 (40.0%) diagnoses of PCa, overall PCa detection rate 2.8%. Mean age at diagnosis 64.1yrs (range 57-73; median 64). Using NCCN criteria (2023) 103/187 (55.1%) of cancers were Intermediate or High Risk; 40/187 (21.4%) were Intermediate Unfavourable/High/Very High Risk. 119/187 (63.6%) men had a PSA <3.0ug/L; PPV of biopsy for PSA > 3.0ug/L was 49.6%. PPV of MRI (presence of PI-RADS 3-5 lesion) 60.4%. PPV of PRS alone 40%. 103/187 (55.1%) had Gleason >7; compared with 360/1014 (35.5%) p < 0.001 in the PSA directed ERSPC study. Conclusions: A population PCa screening program using PRS risk-stratification enriches for clinically significant PCa requiring treatment. It detects a high proportion of clinically significant disease compared with PSA or MRI based screening programs and MRI missed a significant proportion (17-67%) of cancers found on biopsy. This is the first study to assess if this approach will be useful in population screening programs. Clinical trial information: NCT03857477 . [Table: see text]
You have accessJournal of UrologyHealth Services Research: Quality Improvement & Patient Safety III (PD62)1 May 2024PD62-08 THE MAN VAN PROJECT: SECOND PHASE INTERIM RESULTS Masood Moghul, Fionnuala Croft, Fiona Mutch, Elisabeth Westaway, Netty Kinsella, Declan Cahill, and Nicholas D. James Masood MoghulMasood Moghul , Fionnuala CroftFionnuala Croft , Fiona MutchFiona Mutch , Elisabeth WestawayElisabeth Westaway , Netty KinsellaNetty Kinsella , Declan CahillDeclan Cahill , and Nicholas D. JamesNicholas D. James View All Author Informationhttps://doi.org/10.1097/01.JU.0001008656.89655.67.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Early intervention is potentially lifesaving in prostate cancer. The Man Van project ran a successful pilot designed to address health inequalities that affect prostate cancer with a highly novel community-based targeting of high-risk groups on a mobile unit. Following the pilot the project was redesigned to increase efficiency and throughput of patients and relaunched as a nurse-led service. METHODS: A bespoke mobile clinical unit was moved to community-based locations in areas of high deprivation indices in London, UK, with targeted invitations to high-risk men via primary care. Men were offered prostate-specific antigen test counselling and a general health check including: blood pressure, body mass index and an HbA1c test for diabetes. Patient throughput was increased by reducing appointment times from 30 to 15 minutes, with capacity for over 100 patients per week. Efficiency was increased by developing an online registration system with pre-attendance questionnaires. Multiple text message reminders were utilised to reduce non-attendance rates. RESULTS: Between January 2023 and June 2023, 1431 men booked to be seen at Man Van clinics. 1234 men attended with a 10% non-attendance rate (previously 24%). The median age of attendees was 59 years, range 39-97. 64% of attendees were white and 11% had Black ethnicity. 108 referrals for elevated PSA were made on cancer pathways. The median PSA was 5.95g/L, (range 2.61-167g/L). 91 patients had MRI scans of the prostate of which 58% scored PIRADS 1 or 2, 12% were PIRADS 3 and 30% were either PIRADS 4 or 5. 45 patients underwent prostate biopsies with 34 prostate cancers diagnosed (76% of biopsies) yielding an overall diagnostic rate of 2.8%. 31 of these cancers (91%) were clinically significant (Gleason 3+4 >5% or higher grade). No prostate cancers were metastatic at presentation, with only one being T4. The overall diagnostic rate of clinically significant disease was 2.5%. Thus far 12 patients (35%) have been managed on active surveillance, 12 patients with radical robotic prostatectomy and 10 patients with radiotherapy. 37 patients were referred for haematuria investigations with 2 bladder cancers diagnosed. Both of these were high-grade and one was metastatic at presentation. CONCLUSIONS: The Man Van project has evolved into a more efficient service utilising online registration systems and developing into a nurse-led service. By combining patient targeting through primary care with awareness raising through local community groups we have maintained participation rates of ethnic minorities. Multiple text message reminders have reduced our non-attendance rates. Of relevance is our diagnostic rate, with the overwhelming majority of cancers found to be Gleason 3+4 (>5%) or a higher grade. The difference between this rate and similar large scale screening studies suggests that our strategy of targeting high-risk men does skew the case mix towards higher-risk disease. Source of Funding: NHS England © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1288 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Masood Moghul More articles by this author Fionnuala Croft More articles by this author Fiona Mutch More articles by this author Elisabeth Westaway More articles by this author Netty Kinsella More articles by this author Declan Cahill More articles by this author Nicholas D. James More articles by this author Expand All Advertisement PDF downloadLoading ...