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INTRODUCTION: In an MRI-guided linear accelerator (MR-LINAC) system, the planned doses for organs at risk and for tumours are assessed by MR imaging and re-contouring at every treatment. This allows treatment to be safer and more precise by ensuring that it is suitable for the state of the patient's organs on that day, as well as by allowing images to be acquired during radiation therapy to prevent radiation while organs are in motion.Here, we will conduct a confirmatory study of two-fractionated stereotactic magnetic resonance-guided adaptive radiation therapy for patients with localised prostate cancer. METHODS AND ANALYSIS: This will be a single-arm study to demonstrate the safety and efficacy of ultra-hypofractionated radiation (26 Gy/2 Fr) using an MR-LINAC system in patients with very low-intermediate risk prostate cancer.The primary endpoint will be the incidence of grade ≥2 acute urinary tract adverse events occurring within 90 days of the start of radiation therapy.The sample size has been determined to be 58. ETHICS AND DISSEMINATION: This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects, published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare and the modified act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee of the National Cancer Center on 20 November 2021.The findings of this trial will be submitted to an international peer-reviewed journal and the key findings will be presented at an international scientific conference.Authorship will be ascribed in accordance with the International Committee of Medical Journal Editors guidance. TRIAL REGISTRATION NUMBER: UMIN000049746.

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INTRODUCTION: Benign prostatic hyperplasia (BPH) is a condition commonly seen among men aged over 40, significantly affecting their quality of life and typically accompanied by lower urinary tract symptoms (LUTS). Acupuncture presents a potentially effective treatment option; however, the exact effects remain uncertain. Therefore, we design this multicentre randomised trial to evaluate the efficacy and safety of electroacupuncture (EA) for relieving LUTS in men with BPH. METHODS AND ANALYSIS: A two-arm, sham-controlled, subject-blinded and assessor-blinded trial will be conducted in 11 hospitals in China to compare EA with sham electroacupuncture (SA) in treating moderate to severe LUTS of BPH among men aged 40-80. A total of 306 eligible male patients will be recruited and assigned at a 1:1 ratio to receive either EA or SA for 24 sessions over a succession of 8 weeks, with 24 weeks of follow-up. The primary outcome will be the proportions of participants with at least 30% reduction in the International Prostate Symptom Score total score from baseline at weeks 8 and 20. All statistical analyses will be conducted in accordance with the intention-to-treat principle, and a two-tailed p value less than 0.05 will be considered statistically significant. ETHICS AND DISSEMINATION: The trial has been approved by the institutional review board of Guang'anmen Hospital (2022-203-KY), as well as other recruitment centres. Each participant will receive the detailed information of the trial, and sign the written informed consent. The results of the trial are expected to be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05585450.

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OBJECTIVE: This study aimed to systematically investigate the relationship between immune-inflammatory indexes with lower urinary tract symptoms (LUTSs). DESIGN: Cross-sectional study. SETTING: National Health and Nutrition Examination Survey (NHANES) (2005-2008). PARTICIPANTS: A total of 2709 men with complete information for immune-inflammatory indexes and LUTSs were included from NHANES 2005-2008. OUTCOMES AND ANALYSES: Automated haematology analysing devices are used to measure blood cell counts, and LUTSs were presented by standard questionnaires. Non-linear and logistic regression analyses were used to estimate their association after adjustment for confounders. RESULTS: Multivariate logistic regression showed that pan-immune-inflammation value (OR (95% CI)=1.60 (1.14 to 2.23)), systemic inflammation response index (SIRI) (OR (95% CI)=1.82 (1.21 to 2.73)), neutrophil/lymphocyte ratio (NLR) (OR (95% CI)=1.81 (1.31 to 2.49)), derived NLR (dNLR) (OR (95% CI)=1.91 (1.35 to 2.70)) and C reactive protein (CRP) (OR (95% CI)=1.71 (1.05 to 2.79)) was positively associated with LUTS. Additionally, composite immune-inflammation markers exhibited a stronger association with LUTS than any single index, with the ORs for high SIRI+high CRP, high NLR+high CRP and high dNLR+high CRP being 2.26, 2.44 and 2.16, respectively (all p<0.05). Furthermore, subgroup analyses revealed that age, smoking status and hypertension have different effects on the relationship between immune-inflammatory markers and LUTS. CONCLUSIONS: This study indicated that high levels of immune-inflammatory markers were associated with an increased risk of clinical LUTS. The combination of CRP with SIRI, NLR and dNLR, respectively, showed a stronger positive correlation with clinical LUTS compared with any single index.

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Benign prostatic hyperplasia (BPH) occurs when there is an imbalance between the proliferation and death of prostate cells, which is regulated tightly by estrogen signaling. However, the role of G protein-coupled estrogen receptor (GPER) in prostate cell survival remains ambiguous. In this study, we observed that prostates with epithelial hyperplasia showed increased yes-associated protein 1 (YAP) expression and decreased levels of estrogen and GPER. Blocking YAP through genetic or drug interventions led to reduced proliferation and increased apoptosis in the prostate epithelial cells. Interestingly, GPER agonists produced similar effects. GPER activation enhanced the phosphorylation and degradation of YAP, which was crucial for suppressing cell proliferation and survival. The Gαs/cAMP/PKA/LATS pathway, downstream of GPER, transmitted signals that facilitated YAP inhibition. This study investigated the interaction between GPER and YAP in the prostate epithelial cells and its contribution to BPH development. It lays the groundwork for future research on developing BPH treatments.

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【Objective】 To explore the application value of transrectal contrast-enhanced ultrasound (CEUS) microangiography, elastography and conventional ultrasound-guided prostate cancer puncture biopsy in the diagnosis of prostate diseases, so as to provide reference for the early diagnosis of prostate cancer. 【Methods】 A total of 156 patients suspected of prostate cancer treated in our hospital during Jan.2021 and Dec.2022 were selected.The patients were divided into group A (n=52, conventional ultrasound), group B (n=49, elastography) and group C (n=55, CEUS microangiography) according to the puncture methods.The positive rate of puncture and diagnostic value of the three methods were analyzed. 【Results】 The positive rate of puncture was 24.18% in group B and 25.71% in group C, which was significantly higher than that in group A (13.15%, P<0.05).The diagnostic accuracy of prostate cancer was 93.88% in group B and 94.55% in group C, higher than that in group A (75.00%, P=0.002).In group B, the Emax and Emean of malignant lesions were (65.56±14.43) kPa and (59.59±11.02) kPa, respectively, which were higher than those of benign lesions (P<0.001).The difference in blood flow grade detected by CEUS microangiography was statistically significant between benign and malignant lesions, and grade 3 blood flow accounted for 95.65% of malignant lesions.The area under the receiver operating characteristic (ROC) curve (AUC) of Emean in elastography in the diagnosis of prostate cancer was 0.810 (95%CI: 0.690-0.930, P<0.05).The AUC of CEUS microangiography in the diagnosis of prostate cancer was 0.965 (95%CI: 0.913-1.000, P<0.05). 【Conclusion】 Compared with conventional ultrasound-guided prostate cancer puncture biopsy, CEUS microangiography and elastography guided prostate cancer puncture biopsy have better application value in the diagnosis of prostate diseases, which can provide semi-quantitative/quantitative parameter basis for the diagnosis of prostate diseases.

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Prostate cancer (PC) is one of the principal causes of cancer death worldwide. The mortality rate for PC in the Caribbean is higher than in many developed countries, and there is a difference in the incidence among the various Caribbean nations. Besides surveillance and screening, these factors increase concerns about genetic and other risk factors causing PC incidence. PC research is limited in scope and regularity in the Caribbean, creating a literature gap. This literature review aims to examine the PC situation in the Caribbean to highlight where further studies are needed. This review includes all available studies on PC in the specified Caribbean population from 1958 to 2023 utilising the keywords "Prostate Cancer and Caribbean" on PubMed, Scopus, and ScienceDirect databases. The information is then structured by Caribbean countries and by seven themes. These themes are PC incidence and mortality, demographics, clinicopathology, genetics, non-genetic risks, diagnosis and treatment, and PC control. The findings demonstrated that countries with low resources are burdened by more severe illnesses with worse PC outcomes. Furthermore, territories with national cancer registries seemed to have enhanced methods for PC management. In conclusion, this review is significant because it provides initial support for researchers, administrators, and planners for PC healthcare. Additionally, it gives an opportunity for further epidemiological analyses that can supply more significant insights into the PC situation in the Caribbean. Further research should focus on prevention strategies and the standardisation of treatment procedures to enhance surveillance and improve patient outcomes.

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BACKGROUND: Immunoglobulin G4-related prostate disease (IgG4-RPD) characterized by a high count of IgG4-positive plasma cells has distinctive serological and radiological findings. Here we report a case of a patient who was successfully treated for IgG4-RPD, which manifested as frequent micturition, dysuric, and systemic lymphadenopathy. CASE SUMMARY: The patient was a 33-year-old man who was referred to our hospital because of urinary tract symptoms that had persisted for 4 years. A physical examination revealed systemic lymphadenopathy and blood tests showed hyperglobulinemia with an IgG level of 18.90 g/L and an IgG4 level of 18.40 g/L. Computed tomography (CT) revealed bilateral lacrimal gland, right parotid gland and prostatic enlargement. Based on these findings, IgG4-RD was suspected, and further pathological examination and follow-up results showed expected results. Finally, the patient was diagnosed with IgG4-RPD based on clinical symptoms, pathological examination, therapeutic effects, and follow-up results. He received 50 mg oral prednisolone (the dose was gradually reduced and a low dose was used for long-term maintenance) in combination with cyclophosphamide 1.0 g via an intravenous drip for 6 mo. One year after the treatment was initiated, he was free of urinary or other complaints and his serum IgG4 level normalized. CONCLUSION: In IgG4-RPD with severe urinary tract symptoms, radiological findings should be carefully examined. IgG4-RPD prognosis is good because the disease responds well to glucocorticoids. Furthermore, it is urgent for clinicians and pathologists to improve their understanding of IgG4-RPD.

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OBJECTIVES: We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services. DESIGN/SETTING: We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services. RESULTS: In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p<0.001) and host the regional specialist multidisciplinary team (p=0.002). CONCLUSIONS: There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.

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Introduction: Benign prostate hyperplasia (BPH) and prostate cancer (PCa) are major prostate diseases that potentially share cardiometabolic risk factors and an elevated risk for cardiovascular disease (CVD). However, the prevalence of prostate diseases among patients with established CVD remains unclear. Materials and methods: This nationwide retrospective study assessed the prevalence and temporal trend of prostate diseases (i.e., BPH or PCa) among patients hospitalized for CVDs in Japan. We used a claims database (the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination), which included data on 6,078,487 male patients recorded from 1,058 hospitals between April 2012 and March 2020. We conducted the Cochran-Armitage trend test and calculated the adjusted odds ratio (aOR) with 95% confidence intervals (CIs). Results: The prevalence of prostate diseases over the entire study period was 5.7% (BPH, 4.4%; PCa, 1.6%). When dividing the overall cohort into age categories (<65, 65-74, and ≥75 years old), the prevalence was 1.1%, 4.7%, and 9.9%, respectively (P for trend <0.05). In addition, the annual prevalence showed a modest increasing trend over time. Patients admitted for heart failure (HF) were significantly associated with a higher incidence of coexisting prostate diseases than those admitted for non-HF causes [aOR 1.02 (95% CI, 1.01-1.03)] or acute coronary syndrome [aOR 1.19 (95% CI, 1.17-1.22)]. Conclusions: The nationwide real-world database revealed that the prevalence of prostate diseases is increasing among patients hospitalized for CVD, particularly HF. Attention to detailed causality and continued surveillance are needed to further clarify the clinical characteristics of prostate diseases among patients with CVD.

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OBJECTIVE: To identify key areas for research in prostate cancer (PC) in the Ugandan context by establishing the major health system, socioeconomic and clinical barriers to seeking, reaching and receiving high-quality cancer care. DESIGN: Modified Delphi Technique. SETTING: Government and private-not-for-profit hospitals. METHODS: We applied a two-stage modified Delphi technique to identify the consensus view across cancer experts. In round 1, experts received a questionnaire containing 21 statements drawn from a systematic review identifying the reason for the delay in accessing cancer care. Each statement was scored out of 20. Statements scoring ≥15 from over 70% of participants were prioritised for inclusion while statements for which <30% of participants gave a score of ≥15 were excluded. Sixteen statements were included in round 2 as they did not receive consensus for inclusion or exclusion. RESULTS: We found that the top six research priority areas arise from challenges including: (1) lack of diagnostic services-ultrasound, laboratory tests and biopsy facilities; (2) high costs of services, for example, surgery, radiotherapy, hormone therapy are unaffordable to most patients, (3) lack of essential medicines, (4) limited radiotherapy capacity, (5) lack of awareness of cancer as a disease and low recognition of symptoms, (6) low healthcare literacy. The lack of critical surgical supplies, high diagnostic and treatment costs were ranked highest in order of importance in round 1. Round 2 also revealed lack of diagnostic services, unavailability of critical medicines, lack of radiotherapy options, high costs of treatments and lack of critical surgical supplies as the top priorities. CONCLUSION: These research priority areas ought to be addressed in future research to improve prompt PC diagnosis and care in Uganda. There is need to improve the supply of high-quality affordable anticancer medicines for PC patients so as to improve the survivorship from the cancer.

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INTRODUCTION: The primary objective of the Danish Prostate Cancer Consortium Study 1 (DPCC-1) is to provide validation for a novel urine-based microRNA biomarker, called uCaP, for a diagnosis of prostate cancer. METHODS AND ANALYSIS: Eligible participants are biopsy naïve men aged ≥18 years with prostate-specific antigen (PSA) levels ≥3 ng/mL, who are referred to prostate MRI due to suspicion of PC at one of the following three major urology/uroradiology centers: Aarhus University Hospital, Herlev & Gentofte University Hospital, or Odense University Hospital, where MRI and targeted biopsy are implemented in clinical use. Exclusion criteria include previous diagnosis of urogenital cancer, contraindication to MRI, gender reassignment treatment or PSA level >20 ng/mL. The participants will be asked to donate a urine sample in connection with their MRI. The study is observational, uses a diagnostic accuracy testing setup and will integrate into the current diagnostic pathway.We will measure the levels of the three microRNAs in the uCaP model (miR-222-3 p, miR-24-3 p and miR-30c-5p) in extracellular vesicle-enriched cell-free urine samples, to assess if uCaP can improve specificity and retain sensitivity for International Society of Urological Pathology Grade Group ≥2 PC, when used as a reflex test to PSA ≥3 ng/mL. We hypothesise that uCaP can improve selection for prostate MRI and reduce the number of unnecessary scans and biopsies. ETHICS AND DISSEMINATION: This study is approved by the Central Denmark Region Committee on Health Research Ethics (reference number: 1-10-72-85-22). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented in scientific meetings. TRIAL REGISTRATION NUMBER: NCT05767307 at clinicaltrials.gov.

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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.

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CONTEXT: The T4DM study randomized 1007 men with impaired glucose tolerance or newly diagnosed diabetes to testosterone undecanoate (TU, 1000 mg) or matching placebo (P) injections every 12 weeks for 24 months with a lifestyle program with testosterone (T) treatment reducing diabetes diagnosis by 40%. BACKGROUND: The long-term effects on new diagnosis of diabetes, cardiovascular and prostate disease, sleep apnea, weight maintenance trajectory and androgen dependence were not yet described. METHODS: A follow-up email survey after a median of 5.1 years since last injection obtained 599 (59%) completed surveys (316 T, 283 P), with participants in the follow-up survey compared with nonparticipants in 23 anthropometric and demographic variables. RESULTS: Randomization to was TU associated with stronger belief in study benefits during (64% vs 49%, P < .001) but not after the study (44% vs 40%, P = .07); there is high interest in future studies. At T4DM entry, 25% had sleep apnea with a new diagnosis more frequent on TU (3.0% vs 0.4%, P = .03) during, but not after, the study. Poststudy, resuming prescribed T treatment was more frequent among TU-treated men (6% vs 2.8%, P = .03). Five years after cessation of TU treatment there was no difference in self-reported rates of new diagnosis of diabetes, and prostate or cardiovascular disease, nor change in weight maintenance or weight loss behaviors. CONCLUSION: We conclude that randomized T treatment for 24 months in men with impaired glucose tolerance or new diabetes but without pathological hypogonadism was associated with higher levels of self-reported benefits and diagnosis of sleep apnea during, but not after, the study as well as more frequent prescribed poststudy T treatment consistent with androgen dependence in some men receiving prolonged injectable TU.

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INTRODUCTION: Artificial intelligence (AI) has been on the rise in the field of pathology. Despite promising results in retrospective studies, and several CE-IVD certified algorithms on the market, prospective clinical implementation studies of AI have yet to be performed, to the best of our knowledge. In this trial, we will explore the benefits of an AI-assisted pathology workflow, while maintaining diagnostic safety standards. METHODS AND ANALYSIS: This is a Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence compliant single-centre, controlled clinical trial, in a fully digital academic pathology laboratory. We will prospectively include prostate cancer patients who undergo prostate needle biopsies (CONFIDENT-P) and breast cancer patients who undergo a sentinel node procedure (CONFIDENT-B) in the University Medical Centre Utrecht. For both the CONFIDENT-B and CONFIDENT-P trials, the specific pathology specimens will be pseudo-randomised to be assessed by a pathologist with or without AI assistance in a pragmatic (bi-)weekly sequential design. In the intervention group, pathologists will assess whole slide images (WSI) of the standard hematoxylin and eosin (H&E)-stained sections assisted by the output of the algorithm. In the control group, pathologists will assess H&E WSI according to the current clinical workflow. If no tumour cells are identified or when the pathologist is in doubt, immunohistochemistry (IHC) staining will be performed. At least 80 patients in the CONFIDENT-P and 180 patients in the CONFIDENT-B trial will need to be enrolled to detect superiority, allocated as 1:1. Primary endpoint for both trials is the number of saved resources of IHC staining procedures for detecting tumour cells, since this will clarify tangible cost savings that will support the business case for AI. ETHICS AND DISSEMINATION: The ethics committee (MREC NedMec) waived the need of official ethical approval, since participants are not subjected to procedures nor are they required to follow rules. Results of both trials (CONFIDENT-B and CONFIDENT-P) will be published in scientific peer-reviewed journals.

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Prostatitis is a very common disease, with the growth of age, in addition to wrinkles, weight in the longer, the male prostate may also become longer, so there is prostatic hyperplasia (BPH), when its gradual proliferation compression bladder outlet and urethra, will cause dysuria and other symptoms. Simply put, prostatitis causes hyperplasia of the prostate, and prostatitis increases the risk of prostate cancer (Pca). Prostate disease afflicts many men. Therefore, accurate diagnosis of prostate disease is very important for athletic patients to seek medical treatment in time. Multiparametric magnetic resonance imaging (mp-MRI) is a non-invasive imaging technique with superior diagnostic performance compared to other imaging modalities, such as ultrasound and computed tomography. It is widely used in the diagnosis of prostate disease. Advances in science and technology, high-field magnets and new magnetic coil designs (including intra-rectal coils and multichannel surface coils), as well as more advanced software and computational algorithms, allow more sophisticated functional imaging to be incorporated into clinical imaging. The diagnosis of prostate disease has also become faster and more accurate, bringing good news to athletic patients. (AU)

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INTRODUCTION: Prostate cancer (PCa) is men's second most predominant cancer worldwide. Because the prostate-specific antigen test is used in diagnostics, PCa is more often diagnosed in the early stages, making radical treatment of the disease possible. However, it is estimated that over a million men worldwide suffer from radical treatment-related complications. Thus, focal treatment has been proposed as a solution, which aims to destroy the predominant lesson that determines the progression of the disease. The main objective of our study is to compare the quality of life and efficacy of patients diagnosed with PCa before and after the treatment with focal high-dose-rate brachytherapy and to compare results with focal low-dose-rate brachytherapy and active surveillance. METHODS AND ANALYSIS: 150 patients diagnosed with low-risk or favourable intermediate-risk PCa who meet the inclusion criteria will be enrolled in the study. Patients are going to be randomly assigned to the study groups: focal high-dose-rate brachytherapy (group 1), focal low-dose-rate brachytherapy (group 2) and active surveillance (group 3). The study's primary outcomes are quality of life after the procedure and time without biochemical disease recurrence. The secondary outcomes are early and late genitourinary and gastrointestinal reactions after the focal high-dose and low-dose-rate brachytherapies and evaluation of the importance and significance of in vivo dosimetry used for high-dose-rate brachytherapy. ETHICS AND DISSEMINATION: Bioethics committee approval was obtained before this study. The trial results will be published in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: Vilnius regional bioethics committee; approval ID 2022/6-1438-911.

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INTRODUCTION: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer. METHODS AND ANALYSIS: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer. ETHICS AND DISSEMINATION: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT04815876.

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OBJECTIVE AND SETTING: To study longitudinally cancer-related experiences of spouses of patients with prostate cancer and the predictors of their psychological recovery and quality of life (QOL) by following the participants of our previous survey at primary cancer treatment in a university hospital. DESIGN: A 5-year longitudinal cohort design. PARTICIPANTS AND PROCEDURE: A follow-up questionnaire was mailed to the female spouses/partners who participated in our previous survey (n=104). We quantitatively explored the spouses' prostate cancer-related experiences since the previous survey and measured their current psychological symptom distress and well-being/QOL. Seventy-seven (74%) of the initial participants responded. OUTCOMES: The main outcome measures were the spouses' psychological recovery (psychological symptoms at the initial survey vs currently) and well-being/QOL (depressive symptoms, domains of QOL) at 5 years. We analysed their predictors with regression analyses. RESULTS: The treatment had been prostatectomy in 70% of the patients. Psychological distress had alleviated in 76% of spouses (p<0.001) and emotional changes decreased (p=0.02), but a deteriorating impact on the partnership (from 4% to 16%) and on sex life ('strong impact' from 23% to 37%) had increased. The outcomes were inversely associated with negative depression-related psychological symptoms and emotional changes either initially or at follow-up. However, some early experiences also predicted the outcomes when other factors were controlled for. Prostate cancer-related information received by the spouses from several sources (leaflets/handouts, TV/radio, internet) predicted better recovery and well-being/QOL, whereas the patients' prostate cancer and treatment-related symptoms (pain, irritability/anger, bowel dysfunction) predicted poorer recovery and well-being/QOL in spouses. CONCLUSIONS: A major negative impact of prostate cancer was experienced by the spouses still 5 years after primary treatment. Early prostate cancer-related experiences predicted long-term psychological recovery and QOL. Responding to the early information needs of spouses and effective symptom management for the patients are likely to enhance the spouses' long-term recovery and well-being.

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INTRODUCTION: Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach. METHODS: Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial. TRIAL REGISTRATION NUMBER: NCT04571840.

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Immunoglobulin G4-related disease (IgG4-RD) is a systemic fibroinflammatory disease characterized by raised serum IgG4 levels and tumefactive inflammation affecting multiple organ systems, typically involving the pancreas and biliary tree. Though rare, prostatic involvement has been reported in a few cases and is suspected to be an underreported entity. Our patient is a 63-year-old gentleman who has presented with an incidental "PI-RADS 5" (Prostate Imaging Reporting & Data System) prostate lesion and perivascular soft tissue cuffing of the superior rectal vessels on MRI rectum performed for surveillance of rectal neuroendocrine tumor. He had a history of lacrimal gland IgG4-RD. The lentiform prostate lesion subtly indents the prostate capsule, reminiscent of a periprostatic rather than an intraprostatic lesion. Perivascular cuffing of superior rectal vessels suggest inflammatory vasculitis of IgG4-RD. Differential diagnosis of periprostatic inflammatory IgG4-RD was considered, subsequently proven on MRI-ultrasound fusion targeted biopsy. Reported radiological findings of prostate IgG4-RD typically show diffuse chronic inflammation of the prostate, with a minority of the reports describing focal involvement, often mimicking focal prostate adenocarcinoma. Focal periprostatic involvement of IgG4-RD is an unusual manifestation which should be considered in patients with IgG4-RD who present with a periprostatic pseudotumor. IgG4-RD of the prostate usually responds well to steroid treatment without the need for surgery.