COmparing Urolift and Standard Transurethral resection of prostate Ahead of Radiotherapy in men with urinary symptoms secondary to prostate enlargement in Southwest London and North Cumbria (CO-STAR): a study protocol for a randomised feasibility study.

INTRODUCTION: Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the prostate (TURP) is the mainstay surgical intervention for men with urinary symptoms due to an enlarged prostate prior to radiotherapy. UroLift (NeoTract, Pleasanton, CA, USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer. METHODS AND ANALYSIS: A multicentre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and coexisting urinary symptoms due to prostate enlargement to TURP or UroLift ahead of radiotherapy. 45 patients will be enrolled and randomised (1:1) using a computer-generated programme to TURP or UroLift. Recruitment and retention will be assessed over a 12 month period. Information on clinical outcomes, adverse events and costs will be collected. Clinical outcomes and patient reported outcome measures will be measured at baseline, 6 weeks postintervention and 3 months following radiotherapy. A further 12 in-depth interviews will be conducted with a subset of patients to assess acceptability using the Theoretical Framework of Acceptability. Descriptive analysis on all outcomes will be performed using Stata (StataCorp V.2021). ETHICS AND DISSEMINATION: The trial has been approved by the Research Ethics Committee (REC) NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW). The results will be published in peer-reviewed journals, presented at national meetings and disseminated to patients via social media, charity and hospital websites. TRIAL REGISTRATION NUMBER: NCT05840549.

Mobile Health Solutions for Prostate Cancer Diagnostics-A Systematic Review.

Prostate cancer, the most common cause of cancer in men in the UK and one of the most common around the world to date, has no consensus on screening. Multiple large-scale trials from around the world have produced conflicting outcomes in cancer-specific and overall mortality. A main part of the issue is the PSA test, which has a high degree of variability, making it challenging to set PSA thresholds, as well as limited specificity. Prostate cancer has a predisposition in men from black backgrounds, and outcomes are worse in men of lower socioeconomic groups. Mobile targeted case finding, focusing on high-risk groups, may be a solution to help those that most need it. The aim of this systematic review was to review the evidence for mobile testing for prostate cancer. A review of all mobile screening studies for prostate cancer was performed in accordance with the Cochrane guidelines and the PRISMA statement. Of the 629 unique studies screened, 6 were found to be eligible for the review. The studies dated from 1973 to 2017 and came from four different continents, with around 30,275 men being screened for prostate cancer. Detection rates varied from 0.6% in the earliest study to 8.2% in the latest study. The challenge of early diagnosis of potentially lethal prostate cancer remains an issue for developed and low- and middle-income countries alike. Although further studies are needed, mobile screening of a targeted population with streamlined investigation and referral pathways combined with raising awareness in those communities may help make the case for screening for prostate cancer.

Best Current Practice and Research Priorities in Active Surveillance for Prostate Cancer-A Report of a Movember International Consensus Meeting.

BACKGROUND: Active surveillance (AS) is recommended for low-risk and some intermediate-risk prostate cancer. Uptake and practice of AS vary significantly across different settings, as does the experience of surveillance-from which tests are offered, and to the levels of psychological support. OBJECTIVE: To explore the current best practice and determine the most important research priorities in AS for prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: A formal consensus process was followed, with an international expert panel of purposively sampled participants across a range of health care professionals and researchers, and those with lived experience of prostate cancer. Statements regarding the practice of AS and potential research priorities spanning the patient journey from surveillance to initiating treatment were developed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Panel members scored each statement on a Likert scale. The group median score and measure of consensus were presented to participants prior to discussion and rescoring at panel meetings. Current best practice and future research priorities were identified, agreed upon, and finally ranked by panel members. RESULTS AND LIMITATIONS: There was consensus agreement that best practice includes the use of high-quality magnetic resonance imaging (MRI), which allows digital rectal examination (DRE) to be omitted, that repeat standard biopsy can be omitted when MRI and prostate-specific antigen (PSA) kinetics are stable, and that changes in PSA or DRE should prompt MRI ± biopsy rather than immediate active treatment. The highest ranked research priority was a dynamic, risk-adjusted AS approach, reducing testing for those at the least risk of progression. Improving the tests used in surveillance, ensuring equity of access and experience across different patients and settings, and improving information and communication between and within clinicians and patients were also high priorities. Limitations include the use of a limited number of panel members for practical reasons. CONCLUSIONS: The current best practice in AS includes the use of high-quality MRI to avoid DRE and as the first assessment for changes in PSA, with omission of repeat standard biopsy when PSA and MRI are stable. Development of a robust, dynamic, risk-adapted approach to surveillance is the highest research priority in AS for prostate cancer. PATIENT SUMMARY: A diverse group of experts in active surveillance, including a broad range of health care professionals and researchers and those with lived experience of prostate cancer, agreed that best practice includes the use of high-quality magnetic resonance imaging, which can allow digital rectal examination and some biopsies to be omitted. The highest research priority in active surveillance research was identified as the development of a dynamic, risk-adjusted approach.

Developing a consensus statement for psychosocial support in active surveillance for prostate cancer.

Purpose: Our objective was to prioritise the psychosocial support needs of men on active surveillance for prostate cancer and to develop a consensus statement to provide guidance on best practice psychosocial support for men choosing active surveillance and their families. Subjects and methods: We undertook a patient and public involvement Delphi process over two rounds, informed by qualitative data and a comprehensive literature review, to prioritise the information and support needs of men on active surveillance for prostate cancer. Two panels were surveyed, a patient/carer panel (n = 55) and a health care provider panel (n = 114). Based on the findings of the Delphi surveys, an expert active surveillance discussion group developed a consensus statement to guide best practice. Results: Patients and health care professionals differed slightly in their ideas concerning priorities for active surveillance psychosocial support. Broadly, agreed priority areas included -patients being involved in decision-making, continuity of care, more streamlined access to health care teams, improved understanding of the risk of prostate cancer progression and information and support provided through both health care professionals and peers. Based on the identified priorities, the expert discussion group agreed on 22 consensus statements for best practice in psychosocial care for active surveillance in respect of (1) principles of an active surveillance programme; (2) structure of consultations; (3) content of information and support; and (4) delivery of information. Conclusion: This consensus statement provides a framework for patient-focused psychosocial support, which, if adopted, should increase uptake and adherence to active surveillance among men with prostate cancer.

A Systematic Review of Heterogeneity in Outcome Definition and Reporting in Localised Renal Cancer.

Context: Outcomes in renal cell carcinoma (RCC) are reported inconsistently, with variability in definitions and measurement. Hence, it is difficult to compare intervention effectiveness and synthesise outcomes for systematic reviews and to create clinical practice guidelines. This uncertainty in the evidence makes it difficult to guide patient-clinician decision-making. One solution is a core outcome set (COS): an agreed minimum set of outcomes. Objective: To describe outcome reporting, definitions, and measurement heterogeneity as the first stage in co-creating a COS for localised renal cancer. Evidence acquisition: We systematically reviewed outcome reporting heterogeneity in effectiveness trials and observational studies in localised RCC. In total, 2822 studies (randomised controlled trials, cohort studies, case-control studies, systematic reviews) up to June 2020 meeting our inclusion criteria were identified. Abstracts and full texts were screened independently by two reviewers; in cases of disagreement, a third reviewer arbitrated. Data extractions were double-checked. Evidence synthesis: We included 149 studies and found that there was inconsistency in which outcomes were reported across studies and variability in the definitions used for outcomes that were conceptually the same. We structured our analysis using the outcome classification taxonomy proposed by Dodd et al. Outcomes linked to adverse events (eg, bleeding, outcomes linked to surgery) and renal injury outcomes (reduced renal function) were reported most commonly. Outcomes related to deaths from any cause and from cancer were reported in 44% and 25% of studies, respectively, although the time point for measurement and the analysis methods were inconsistent. Outcomes linked to life impact (eg, global quality of life) were reported least often. Clinician-reported outcomes are more frequently reported than patient-reported outcomes in the renal cancer literature. Conclusions: This systematic review underscores the heterogeneity of outcome reporting, definitions, and measurement in research on localised renal cancer. It catalogues the variety of outcomes and serves as a first step towards the development of a COS for localised renal cancer. Patient summary: We reviewed studies on localised kidney cancer and found that multiple terms and definitions have been used to describe outcomes. These are not defined consistently, and often not defined at all. Our review is the first phase in developing a core outcome set to allow better comparisons of studies to improve medical care.

Understanding reasons for non-adherence to active surveillance for low-intermediate risk prostate cancer.

BACKGROUND: Active surveillance (AS) is recommended by most national medical organizations as the preferred treatment option for men with low-risk prostate cancer (PCa). However, studies report that up to one third of men on AS dropout within 5 years, without evidence of disease progression. Despite high dropout rates, few studies have purposively explored the opinions and experiences of men who discontinued AS. The aim of this study was to gain insight into the reasons why some men on AS for PCa discontinue active treatment without evidence of disease progression. METHODS: Semi-structured interviews were undertaken with 14 men from diverse socio-cultural backgrounds who had been on AS for PCa but dropped out of surveillance to undergo active treatment without signs of disease progression. Purposive sampling to reach data saturation was used to select participants based on their experience of AS and willingness to share their experiences. Interviews were transcribed and analysis undertaken in an inductive thematic manner. RESULTS: The following themes arose from interviews as factors that potentially influence adherence to AS: men's experience at diagnosis and follow-up consultations, involvement in shared decision-making, the extent of supportive care and information, administrative procedures and support from partner and peers. A poor experience during diagnosis could adversely influence long-term adherence to AS, given the same diagnostic tests are frequently repeated. The provision of consistent information and support while on AS, similar to that offered to men undergoing radical treatment, was also highlighted as being important to increase confidence in the process. CONCLUSIONS: Effective communications skills among health professionals, aimed at building trust in patient-clinician relationships, providing opportunities for shared decision-making and developing self-efficacy, along with structured information and support, are key to enhancing long-term adherence to AS.

The Current Evidence for Factors that Influence Treatment Decision Making in Localized Kidney Cancer: A Mixed Methods Systematic Review.

PURPOSE: With a growing number of treatment options for localized kidney cancer, patients and health care professionals have both the opportunity and the burden of selecting the most suitable management option. This mixed method systematic review aims to understand the barriers and facilitators of the treatment decision making process in localized kidney cancer. MATERIALS AND METHODS: We searched PubMed®, Embase® and Cochrane Central databases between January 1, 2004 and April 23, 2020 using the Joanna Briggs Manual for Evidence Synthesis and the Preferred Reporting Items for Systematic Review and Meta-analysis statement. We identified 553 unique citations; of these, 511 were excluded resulting in 42 articles included for synthesis. The Purpose, Respondents, Explanation, Findings and Significance and the Strengthening the Reporting of Observational Studies in Epidemiology checklist was applied. RESULTS: The key themes describing barriers and facilitators to treatment decision making were identified and categorized into 3 domains: 1) kidney cancer specific characteristics, 2) decision maker related criteria and 3) contextual factors. The main facilitators identified within these domains were size at diagnosis, age, comorbidities, body mass index, gender, nephrometry scoring systems, biopsy, socioeconomic status, family history of cancer, year of diagnosis, geographic region and practice pattern. The key barriers were race, gender, patient anxiety, low confidence in diagnostic and treatment options, cost of procedure, and practice patterns. CONCLUSIONS: Future interventions designed to improve the decision making process for localized kidney cancer should consider these barriers and facilitators to ensure a better patient experience.

Association Between Preoperative Magnetic Resonance Imaging-based Urethral Parameters and Continence Recovery Following Robot-assisted Radical Prostatectomy.

BACKGROUND: Studies demonstrated the significance of membranous urethral length (MUL) as a predictor of continence following robot-assisted radical prostatectomy (RARP). There are other magnetic resonance imaging (MRI) parameters that might be linked to continence outcome. OBJECTIVE: To evaluate the association between preoperative urethral parameters on MRI and continence outcome, to estimate the risk of incontinence using different cut-off values, and to assess interobserver variability in measuring urethral parameters. DESIGN, SETTING, AND PARTICIPANTS: Patients with localised prostate cancer who underwent RARP were retrospectively reviewed. Baseline patient characteristics, perioperative, and pathological outcomes were assessed. Continence was defined as no pad or a safety pad with <2g/24h pad weight. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Several MRI variables were measured by a uroradiologist, a uro-oncology fellow, and a urologist. Binary logistic regression analyses were performed to identify predictors of incontinence. Interclass correlation was used to evaluate interobserver variability. RESULTS AND LIMITATIONS: A total of 190 patients met the study inclusion criteria. The mean MUL was 14.6mm. Age and MUL were significantly associated with incontinence outcome. The area under the receiver operating characteristic curve for continence based on MUL was 0.78 at 12 mo. The risk of incontinence in patients with MUL of <10mm was 27.8% (13.8% and 39.1% for patients aged <65 and >65 yr respectively). Conversely, the risk of incontinence with MUL >15mm was 2.7% (1.5% and 4.5% for patients aged <65 and >65 yr, respectively). The concordance rate between different observers was 89% for coronal MUL, but 77%, 74%, and 62% for sagittal MUL, membranous urethral thickness, and intraprostatic urethral length, respectively. CONCLUSIONS: This study confirmed the significance of MUL for the continence outcome following RARP. There was also excellent consistency in measuring MUL values between different observers. PATIENT SUMMARY: Although further studies would be required to verify our findings, we support the significance of membranous urethral length in predicting the risk of incontinence and the need to incorporate it as part of preoperative assessment and counselling. This can reliably be measured by urologists and can further facilitate a patient-tailored approach to radical treatment of prostate cancer.

Is there any association between prostate-specific antigen screening frequency and uptake of active surveillance in men with low or very low risk prostate cancer?

BACKGROUND: Patient-related factors such as concern about cancer are believed to influence both men's decisions to undergo prostate specific antigen (PSA) testing and to have definitive treatment if diagnosed with low risk prostate cancer (PCa). The potential link between screening frequency and choice of active surveillance (AS) for low risk disease has not been studied previously. Our aim was to investigate whether there is any association between PCa screening frequency or previous negative prostate biopsy and uptake of AS among men with low risk PCa. METHODS: This register-based study included all men ≤75 years from Stockholm who were diagnosed with low risk PCa from 2008 to 2014 (n = 4336). Pre-diagnostic PSA testing and biopsy histories were obtained from the Stockholm PSA and Biopsy Register, a population-based register for the Stockholm country. The association between previous screening/biopsy history and AS uptake (based on primary treatment recorded in the National Prostate Cancer Register) was examined using multivariable logistic regression. RESULTS: Forty seven percent of men with low risk PCa underwent AS. Uptake was associated with older age, very low risk disease, more recent diagnosis and absence of family history. None of the screening/biopsy measures (testing frequency, mean interval, PSA velocity, highest pre-diagnostic PSA or prior negative biopsy) were associated with uptake of AS among men with low risk PCa. Generalisability to settings with different policies and practices may be limited. CONCLUSION: We found no evidence that screening frequency and negative biopsy influence uptake of AS among Swedish men with low risk PCa. Further research is required to determine factors that still present barriers for men taking up AS.

A Single Educational Seminar Increases Confidence and Decreases Dropout from Active Surveillance by 5 Years After Diagnosis of Prostate Cancer.

BACKGROUND: Researchers remain divided on the major causes of dropout from active surveillance (AS), with rates of up to 38% among men with no evidence of prostate cancer (PC) progression. OBJECTIVE: To develop and evaluate an educational intervention in terms of adherence to AS among men with low- to intermediate-risk PC. DESIGN, SETTING, AND PARTICIPANTS: We first carried out focus group discussions with men who had remained on and dropped out of AS to inform an intervention to increase adherence to AS. A total of 255 consecutive men who had selected AS were then recruited to either standard care (written information and access to a nurse specialist) or standard care and the intervention. INTERVENTION: An educational seminar was designed by patients and clinicians including information on imaging, biopsy techniques, understanding pathology, large AS cohorts - mortality and morbidity risk and diet and lifestyle advice. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The proportion of men dropping out of AS for reasons other than disease progression was assessed at 1 and 5yr after AS selection using multivariate logistic regression. RESULTS AND LIMITATIONS: Common themes influencing decision-making by men on AS were identified: (1) clinical consistency; (2) information; and (3) lifestyle advice. Addition of an educational seminar led to significantly fewer men dropping out of AS: at 1 and 5yr the dropout rate was 25% and 42%, respectively, in the standard care group, compared to 11% and 22% (p=0.001) in the intervention group. In the intervention group, 18 men failed to attend the seminar. CONCLUSIONS: The AS dropout rate was halved following a single educational seminar delivered to groups of men with intermediate- or low-risk PC, even at 5yr. PATIENT SUMMARY: Men on active surveillance (AS) for prostate cancer feel more supported when provided with an educational seminar within 3 mo of their treatment choice. The seminar halved the number of men dropping-out of AS, even at 5yr.

Active surveillance for prostate cancer: a systematic review of contemporary worldwide practices.

In the last decade, active surveillance (AS) has emerged as an acceptable choice for low-risk prostate cancer (PC), however there is discordance amongst large AS cohort studies with respect to entry and monitoring protocols. We systematically reviewed worldwide AS practices in studies reporting ≥5 years follow-up. We searched PubMed and Medline 2000-now and identified 13 AS cohorts. Three key areas were identified: (I) patient selection; (II) monitoring protocols; (III) triggers for intervention-(I) all studies defined clinically localised PC diagnosis as T2b disease or less and most agreed on prostate-specific antigen (PSA) threshold (<10 µg/L) and Gleason score threshold (3+3). Inconsistency was most notable regarding pathologic factors (e.g., number of positive cores); (II) all agreed on PSA surveillance as crucial for monitoring, and most agreed that confirmatory biopsy was required within 12 months of initiation. No consensus was reached on optimal timing of digital rectal examination (DRE), general health assessment or re-biopsy strategies thereafter; (III) there was no universal agreement for intervention triggers, although Gleason score, number or percentage of positive cancer cores, maximum cancer length (MCL) and PSA doubling time were used by several studies. Some also used imaging or re-biopsy. Despite consistent high progression-free/cancer-free survival and conversion-to-treatment rates, heterogeneity exists amongst these large AS cohorts. Combining existing evidence and gathering more long-term evidence [e.g., the Movember's Global AS database or additional information on use of magnetic resonance imaging (MRI)] is needed to derive a broadly supported guideline to reduce variation in clinical practice.

Factors Influencing Men's Choice of and Adherence to Active Surveillance for Low-risk Prostate Cancer: A Mixed-method Systematic Review.

CONTEXT: Despite support for active surveillance (AS) as a first treatment choice for men with low-risk prostate cancer (PC), this strategy is largely underutilised. OBJECTIVE: To systematically review barriers and facilitators to selecting and adhering to AS for low-risk PC. EVIDENCE ACQUISITION: We searched PsychINFO, PubMed, Medline 2000-now, Embase, CINAHL, and Cochrane Central databases between 2002 and 2017 using the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The Purpose, Respondents, Explanation, Findings and Significance (PREFS) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) quality criteria were applied. Forty-seven studies were identified. EVIDENCE SYNTHESIS: Key themes emerged as factors influencing both choice and adherence to AS: (1) patient and tumour factors (age, comorbidities, knowledge, education, socioeconomic status, family history, grade, tumour volume, and fear of progression/side effects); (2) family and social support; (3) provider (speciality, communication, and attitudes); (4) healthcare organisation (geography and type of practice); and (5) health policy (guidelines, year, and awareness). CONCLUSIONS: Many factors influence men's choice and adherence to AS on multiple levels. It is important to learn from the experience of other chronic health conditions as well as from institutions/countries that are making significant headway in appropriately recruiting men to AS protocols, through standardised patient information, clinician education, and nationally agreed guidelines, to ultimately decrease heterogeneity in AS practice. PATIENT SUMMARY: We reviewed the scientific literature for factors affecting men's choice and adherence to active surveillance (AS) for low-risk prostate cancer. Our findings suggest that the use of AS could be increased by addressing a variety of factors such as information, psychosocial support, clinician education, and standardised guidelines.