Challenges and options for management of stones in anomalous kidneys: a review of current literature.

Introduction: Congenital anomalies of the kidney and urinary tract (CAKUT) represent a wide range of disorders that result from developmental abnormalities of the kidneys, urinary collecting tract, and lower urinary tract. There has been extensive development in approaches to the management of stones in normal kidneys with the advent of retrograde intra-renal surgeries (RIRS)/ureteroscopies, extracorporeal shock wave lithotripsy (ESWL) percutaneous nephrolithotomy (PCNL), and minimally invasive surgery (laparoscopy/robotics). However, the management of stones in CAKUT is not straightforward and is often challenging for urologists. There are no clear guidelines available to help navigate stone management in such patients. Materials and methods: The aim of this literature review was to focus on stone management in anomalous kidneys. Most common abnormalities were considered. The studies were very heterogeneous with different approaches. The methodology involved evaluating studies looking into individual surgical approaches to the management of stones in these anomalous kidneys as well as looking at different approaches to stone management, in particular renal abnormality. Results: We found RIRS is a feasible approach in most stones with sizes <20 mm and PCNL holds the upper hand in stones more than 20 mm. However, ESWL, laparoscopy, and robotics have their places in managing some of these cases. Conclusion: We concluded that stones in anomalous kidneys can be challenging but can be managed safely. There is no straightforward answer to the right technique but rather the right planning based on the anatomy of the kidney in terms of vascularity and drainage, stone size and density, and expertise available.

The implications when offering percutaneous nephrostomy for the management of malignant obstructive uropathy secondary to urological malignancy: can we be more selective?

Background & Objectives: Percutaneous nephrostomy (PN) for malignant ureteric obstruction (MUO) is increasingly accessible with high success rates. However, it is not without associated risks and morbidity, impacting quality of life, while not improving overall survival. In two UK hospitals, we investigated the outcomes of undergoing PN for MUO, to inform future patient counselling and selection for this intervention. Methods: A retrospective audit of electronic records identified patients that received PN for bladder, and prostate cancer (PCa) between January 2015 and December 2018. Hospital 1 had a 24-h nephrostomy service, while Hospital 2 had a limited service; Group A: recurrent or treatment-resistant PCa, Group B: primary PCa, Group C: Bladder cancer. Results: A total of 261 patients (Hospital 1 = 186, Hospital 2 = 75), had PN insertion. Seventy-eight had prostate or bladder cancer. Group A n = 30, Group B n = 12, Group C n = 36. Median age = 79 [interquartile range (IQR) = 72-86]. Following PN insertion, 12-month mortality was significantly greater in Hospital 1 at 82%, versus 52% in Hospital 2 (p = 0.015). Median survival: Group A: 177 days (IQR = 80-266), Group B: 209 days (IQR = 77-352), Group C: 145 days (IQR = 97-362). There was no significant difference in same-admission mortality, although group A had the greatest same-admission mortality at 17%. A total of 69% of all patients received bilateral nephrostomies. Patients with bilateral versus unilateral PN had no difference in mortality or nadir creatinine. Conclusion: Most patients with malignant obstruction secondary to prostate or bladder cancer lived less than 12 months after PN insertion. When offering PN, careful consideration of disease prognosis should be made, and frank discussion of the implications of a life-long nephrostomy with patients and relatives.

Transperineal laser ablation as a new minimally invasive surgical therapy for benign prostatic hyperplasia: a systematic review of existing literature.

Introduction: Transperineal laser ablation (TPLA) of the prostate is a new, minimally invasive technique for benign prostatic hyperplasia (BPH) with promising effectiveness and safety outcomes. This systematic review aims to provide an update of existing literature. Methods: A literature review was performed in Pubmed/MEDLINE, Embase, Cochrane Library, and clinicaltrials.gov from January 2000 up to April 2023. Data extraction and risk of bias were performed independently by three authors. Results: A total of 11 studies were included, among which 9 were observational, 1 randomized controlled trial, 1 animal study, while 2 of them were comparative (1 with prostatic artery embolization and 1 with transurethral resection of the prostate). Functional outcomes were improved in the majority of studies both for objective (maximum flow rate and post-void residual) and subjective outcomes (improvement of International Prostate Symptom Score and quality of life). Complication rates ranged between 1.9% and 2.3% for hematuria, 3.7% and 36.3% for dysuria, 1.9% and 19% for acute urinary retention, 0.6% and 9.1% for orchitis/urinary tract infections, and 0.6% and 4.8% for prostatic abscess formation. Regarding sexual function, >95% of patients retained their ejaculation while erectile function was maintained or improved. Conclusion: TPLA of the prostate is an innovative, minimally invasive technique for managing patients with BPH. Existing studies indicate an effective technique in reducing International Prostate Symptom Score and quality of life scores, post-void residual reduction, and increase in Qmax, albeit the measured improvements in terms of Qmax are not equal to transurethral resection of the prostate. Although sexual function is maintained, the mean catheterization time is 7 days, and no long-term data are available for most patients.

Venous Thromboembolism (VTE) in Post-Prostatectomy Patients: Systematic Review and Meta-Analysis.

Radical prostatectomy (RP) is one of the recommended treatments to achieve oncological outcomes in localized prostate cancer. However, a radical prostatectomy is a major abdominopelvic surgery. Venous thromboembolism (VTE) is a well-known complication associated with surgical procedures, including RP. There is a lack of consensus regarding VTE prophylaxis in urological procedures. The aim of this systematic review and meta-analysis was to investigate different aspects of VTE in post-radical prostatectomy patients. A comprehensive literature search was performed, and relevant data were extracted. The primary aim was to perform a systematic review and meta-analysis (wherever possible) of VTE occurrence in post-RP patients in relation to surgical approach, pelvic lymph node dissection, and type of prophylaxis (mechanical or combined prophylaxis). The secondary aim was to investigate the incidence and other risk factors of VTE in post-RP patients. A total of 16 studies were included for quantitative analysis. Statistical methods for analysis included the DerSimonian-Laird random effects. We were able to conclude that the overall incidence of VTE in post-radical prostatectomy is 1% (95% CI) and minimally invasive procedures (MIS), including laparoscopic, as well as robotic procedures for radical prostatectomy and RP without pelvic lymph node dissection (PLND), are associated with less risk of developing VTE. Additional pharmacological prophylaxis to mechanical methods may not be necessary in all cases and should be considered in high-risk patients only.

Comparison of Outcomes of Active Surveillance in Intermediate-Risk Versus Low-Risk Localised Prostate Cancer Patients: A Systematic Review and Meta-Analysis.

Currently, there is no clear consensus regarding the role of active surveillance (AS) in the management of intermediate-risk prostate cancer (IRPC) patients. We aim to analyse data from the available literature on the outcomes of AS in the management of IRPC patients and compare them with low-risk prostate cancer (LRPC) patients. A comprehensive literature search was performed, and relevant data were extracted. Our primary outcome was treatment-free survival, and secondary outcomes were metastasis-free survival, cancer-specific survival, and overall survival. The DerSimonian-Laird random-effects method was used for the meta-analysis. Out of 712 studies identified following an initial search, 25 studies were included in the systematic review. We found that both IRPC and LRPC patients had nearly similar 5, 10, and 15 year treatment-free survival rate, 5 and 10 year metastasis-free survival rate, and 5 year overall survival rate. However, cancer-specific survival rates at 5, 10, and 15 years were significantly lower in IRPC compared to LRPC group. Furthermore, IRPC patients had significantly inferior long-term overall survival rate (10 and 15 year) and metastasis-free survival rate (15 year) compared to LRPC patients. Both the clinicians and the patients can consider this information during the informed decision-making process before choosing AS.

Collision metastasis from prostate adenocarcinoma and pancreatic ductal adenocarcinoma to a lung nodule.

Introduction: Prostate cancer and pancreatic cancer are often complex pathologies that affect millions of patients worldwide. However, the incidence of a distant collision metastasis of both malignancies remains a rare and often poorly documented incidence. Case presentation: A 75-year-old male patient with past history of prostate cancer on maximal androgen blockade was recently diagnosed with pancreatic cancer for which he underwent radical surgical resection of pancreas with curative intent. A metastatic lung nodule was noted on surveillance CT imaging and, subsequently, biopsied. A diagnosis of collision metastasis from two distinct primary malignancies was histopathologically confirmed following immunohistochemical evaluation. Conclusion: We report the first case of collision metastasis of prostate and pancreatic adenocarcinomata to a lung nodule to the best of our knowledge.

The Availability, Cost, Limitations, Learning Curve and Future of Robotic Systems in Urology and Prostate Cancer Surgery.

Robot-assisted surgical systems (RASS) have revolutionised the management of many urological conditions over the last two decades with robot-assisted radical prostatectomy (RARP) now being considered by many to be the preferred surgical approach. Intuitive Surgical has dominated the market during this time period with successive iterations of the da Vinci model. The expiration of patents has opened the RASS market and several new contenders have become available or are currently in development. This comprehensive narrative review aims to explore the merits of each robotic system as well as the evidence and barriers to their use. The newly developed RASS have increased the versality of robotic surgical systems to a wider range of settings through advancement in technology. The increased competition may result in an overall reduction in cost, broadening the accessibility of RASS. Learning curves and training remain a barrier to their use, but the situation appears to be improving through dedicated training programmes. Outcomes for RARP have been well investigated and tend to support improved early functional outcomes. Overall, the rapid developments in the field of robot-assisted surgery indicate the beginning of a promising new era to further enhance urological surgery.

What Is New in the Management of High-Risk Localized Prostate Cancer?

The current Special Issue, in the Journal of Clinical Medicine, is dedicated to collecting high-quality research that mainly focuses on "Clinical advances in Prostate Cancer Treatments" [...].

Feasibility of aspirin and/or vitamin D3 for men with prostate cancer on active surveillance with Prolaris® testing.

Objectives: To test the feasibility of a randomised controlled trial (RCT) of aspirin and/or vitamin D3 in active surveillance (AS) low/favourable intermediate risk prostate cancer (PCa) patients with Prolaris® testing. Patients and Methods: Newly-diagnosed low/favourable intermediate risk PCa patients (PSA ≤ 15 ng/ml, International Society of Urological Pathology (ISUP) Grade Group ≤2, maximum biopsy core length <10 mm, clinical stage ≤cT2c) were recruited into a multi-centre randomised, double-blind, placebo-controlled study (ISRCTN91422391, NCT03103152). Participants were randomised to oral low dose (100 mg), standard dose (300 mg) aspirin or placebo and/or vitamin D3 (4000 IU) versus placebo in a 3 × 2 factorial RCT design with biopsy tissue Prolaris® testing. The primary endpoint was trial acceptance/entry rates. Secondary endpoints included feasibility of Prolaris® testing, 12-month disease re-assessment (imaging/biochemical/histological), and 12-month treatment adherence/safety. Disease progression was defined as any of the following (i) 50% increase in baseline PSA, (ii) new Prostate Imaging-Reporting and Data System (PI-RADS) 4/5 lesion(s) on multi-parametric MRI where no previous lesion, (iii) 33% volume increase in lesion size, or radiological upstaging to ≥T3, (iv) ISUP Grade Group upgrade or (v) 50% increase in maximum cancer core length. Results: Of 130 eligible patients, 104 (80%) accepted recruitment from seven sites over 12 months, of which 94 patients represented the per protocol population receiving treatment. Prolaris® testing was performed on 76/94 (81%) diagnostic biopsies. Twelve-month disease progression rate was 43.3%. Assessable 12-month treatment adherence in non-progressing patients to aspirin and vitamin D across all treatment arms was 91%. Two drug-attributable serious adverse events in 1 patient allocated to aspirin were identified. The study was not designed to determine differences between treatment arms. Conclusion: Recruitment of AS PCa patients into a multi-centre multi-arm placebo-controlled RCT of minimally-toxic adjunctive oral drug treatments with molecular biomarker profiling is acceptable and safe. A larger phase III study is needed to determine optimal agents, intervention efficacy, and outcome-associated biomarkers.

Urological Implications Associated with the Use of Recreational Drugs: A Narrative Review.

About 275 million people worldwide aged between 15 and 64 years used drugs at least once since 2016. Initial estimations suggest that 13.8 million young people between 15 and 16 years used cannabis every year. Recreational drug use contributes significantly to mortality as well as physical and mental health problems. A number of urological complications can arise from the use of common and emerging recreational drugs which can present as wide spectrum affecting lower and upper urinary tracts, kidneys, sexual organs as well as sexual dysfunction. In order to effectively manage these issues, urologists need to be cognizant of these complications in their patients, particularly among youths. This review attempted to consolidate available data and provide insight into this issue; however, further population-based epidemiological studies are needed to provide necessary guidelines.

The safety and feasibility of simultaneous robotic repair of an inguinal hernia during robotic-assisted laparoscopic prostatectomy: a systematic review and meta-analysis.

PURPOSE: This study intended to assess the safety and feasibility of performing concurrent robotic-assisted laparoscopic prostatectomy (RALP) and robotic inguinal hernia repair (RIHR). METHOD: We systematically searched the PubMed, Embase and Cochrane Library database up to the year 2020 to identify studies that assessed patients who underwent RALP and RIHR in the same settings. RESULTS: Thirteen studies were considered suitable for a systematic review and seven for Meta-analysis. RALP and RIHR were associated with significantly longer operative time. RIHR added on average 26 min to the operation time (8, 45 95% CI, p = 0.005, I2 97%). Concurrent RALP and RIHR was not associated with a higher incidence of blood loss (-13, 6 95% CI, p = 0.43, I2 18%), length of stay (-0.08, 0.06 95% CI, p = 0.73, I2 0%) or early postoperative complications. CONCLUSION: Concurrent robotic repair of an inguinal hernia during RALP appears feasible and safe. Urologists should be encouraged to repair hernias encountered during RALP keeping in mind possible complications including wound infection, mesh infection, chronic inguinal pain and recurrence of hernia.

Factors Causing Variation in World Health Organization Surgical Safety Checklist Effectiveness-A Rapid Scoping Review.

INTRODUCTION: This review was conducted to determine what factors might be responsible for prejudicing the outcomes after the implementation of a World Health Organization Surgical Safety Checklist (WHO SSC), grouping them appropriately and proposing strategies that enable the SSC a more helpful and productive tool in the operating room. METHODS: It was a rapid scoping review conducted as per Preferred Reporting Items for Systematic Review and Meta-analyses extension guidelines for scoping reviews (PRISMA-Scr). Comprehensive search on MEDLINE and Embase was carried out, to include all relevant studies published during last 5 years. Twenty-seven studies were included in analysis. The barriers to SSC implementation were classified into 5 main groups, with further subdivisions in each. RESULTS: The results of review revealed that there are 5 major barriers to SSC at the following levels: organizational, checklist, individual, technical, and implementation. Each of these major barriers, on further evaluation, was found to have more than one contributing factors. All these factors were analyzed individually. CONCLUSIONS: This rapid scoping review has consolidated data, which may pave the way for experts to further examine steps that might be taken locally or globally in order that the WHO SSC to successfully achieve all its desired goals.

Is there a role for stem cell therapy in erectile dysfunction secondary to cavernous nerve injury? Network meta-analysis from animal studies and human trials.

Introduction: We carried out systematic review and network meta-analysis to investigate the role of stem cell therapy (SCT) in the management of erectile dysfunction (ED) secondary to cavernous nerve injury in rats and post-radical prostatectomy (RP) in humans. Patients and Methods: The protocol was registered with PROSPERO database. We searched studies analyzing the efficacy of SCT for ED due to bilateral cavernous nerve injury (BCNI) in rats using Healthcare Databases Advanced Search (HDAS) Export software (MEDLINE, EMBASE, Scopus) from inception to September 2020. The outcome measurements, for 29 animal studies, were intracavernosal pressure (ICP), ICP/MAP (mean arterial pressure) ratio, and histological/molecular changes. All three available human trials evaluating SCT in post-RP ED were assessed for International Index for Erectile Function (IIEF) Score and Erection Hardness Score (EHS). Results: For ICP measurement, animal studies were divided into adipose-derived stem cells (ADSCs) subgroup and bone marrow-derived stem cells (BMSCs) subgroup. Pooled analysis of these studies showed a beneficial effect of SCT in improving erectile function in rats with BCNI using network meta-analysis (95% confidence interval, CI; p < 0.001). There was an increase in ICP/MAP ratio in stem cell groups (including co-intervention) compared with control BCNI group. Histological and molecular evaluation of penile tissue revealed an increase in neuronal nitric oxide synthase (nNOS), smooth muscle content, and anti-apoptotic activity. Human trials revealed improved IIEF (70-150% from baseline at 6 months) and EHS (80-200% from baseline). Conclusion: Our results confirm that SCT does improve the erectile function in rats having cavernous nerve injury. Similarly, early human results have shown promising results. PROSPERO registration ID: CRD42020201343.

Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study.

BACKGROUND: Multiparametric MRI of the prostate followed by targeted biopsy is recommended for patients at risk of prostate cancer. However, multiparametric ultrasound is more readily available than multiparametric MRI. Data from paired-cohort validation studies and randomised, controlled trials support the use of multiparametric MRI, whereas the evidence for individual ultrasound methods and multiparametric ultrasound is only derived from case series. We aimed to establish the overall agreement between multiparametric ultrasound and multiparametric MRI to diagnose clinically significant prostate cancer. METHODS: We conducted a prospective, multicentre, paired-cohort, confirmatory study in seven hospitals in the UK. Patients at risk of prostate cancer, aged 18 years or older, with an elevated prostate-specific antigen concentration or abnormal findings on digital rectal examination underwent both multiparametric ultrasound and multiparametric MRI. Multiparametric ultrasound consisted of B-mode, colour Doppler, real-time elastography, and contrast-enhanced ultrasound. Multiparametric MRI included high-resolution T2-weighted images, diffusion-weighted imaging (dedicated high B 1400 s/mm2 or 2000 s/mm2 and apparent diffusion coefficient map), and dynamic contrast-enhanced axial T1-weighted images. Patients with positive findings on multiparametric ultrasound or multiparametric MRI underwent targeted biopsies but were masked to their test results. If both tests yielded positive findings, the order of targeting at biopsy was randomly assigned (1:1) using stratified (according to centre only) block randomisation with randomly varying block sizes. The co-primary endpoints were the proportion of positive lesions on, and agreement between, multiparametric MRI and multiparametric ultrasound in identifying suspicious lesions (Likert score of ≥3), and detection of clinically significant cancer (defined as a Gleason score of ≥4 + 3 in any area or a maximum cancer core length of ≥6 mm of any grade [PROMIS definition 1]) in those patients who underwent a biopsy. Adverse events were defined according to Good Clinical Practice and trial regulatory guidelines. The trial is registered on ISRCTN, 38541912, and ClinicalTrials.gov, NCT02712684, with recruitment and follow-up completed. FINDINGS: Between March 15, 2016, and Nov 7, 2019, 370 eligible patients were enrolled; 306 patients completed both multiparametric ultrasound and multiparametric MRI and 257 underwent a prostate biopsy. Multiparametric ultrasound was positive in 272 (89% [95% CI 85-92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73-82]; difference 11·1% [95% CI 5·1-17·1]). Positive test agreement was 73·2% (95% CI 67·9-78·1; κ=0·06 [95% CI -0·56 to 0·17]). Any cancer was detected in 133 (52% [95% CI 45·5-58]) of 257 patients, with 83 (32% [26-38]) of 257 being clinically significant by PROMIS definition 1. Each test alone would result in multiparametric ultrasound detecting PROMIS definition 1 cancer in 66 (26% [95% CI 21-32]) of 257 patients who had biopsies and multiparametric MRI detecting it in 77 (30% [24-36]; difference -4·3% [95% CI -8·3% to -0·3]). Combining both tests detected 83 (32% [95% CI 27-38]) of 257 clinically significant cancers as per PROMIS definition 1; of these 83 cancers, six (7% [95% CI 3-15]) were detected exclusively with multiparametric ultrasound, and 17 (20% [12-31]) were exclusively detected by multiparametric MRI (agreement 91·1% [95% CI 86·9-94·2]; κ=0·78 [95% CI 0·69-0·86]). No serious adverse events were related to trial activity. INTERPRETATION: Multiparametric ultrasound detected 4·3% fewer clinically significant prostate cancers than multiparametric MRI, but it would lead to 11·1% more patients being referred for a biopsy. Multiparametric ultrasound could be an alternative to multiparametric MRI as a first test for patients at risk of prostate cancer, particularly if multiparametric MRI cannot be carried out. Both imaging tests missed clinically significant cancers detected by the other, so the use of both would increase the detection of clinically significant prostate cancers compared with using each test alone. FUNDING: The Jon Moulton Charity Trust, Prostate Cancer UK, and UCLH Charity and Barts Charity.

Complications After Radical Nephrectomy According to Age: Analysis from the British Association of Urological Surgeons Nephrectomy Audit.

Introduction: To compare complication rates in radical nephrectomy (RN) for renal cell carcinoma (RCC) across different age groups. Methods: Retrospective analysis of the British Association of Urological Surgeons Nephrectomy audit database between January 1, 2012, and December 31, 2017, was performed. Comparisons were made between different age groups (<60, 60-79, and ≥80) in patients undergoing RN for RCC. Results: Eighteen thousand four hundred thirty-eight patients with RCC underwent RN: 6128 (33.2%) <60 years of age, 10,785 (58.5%) 60-79 years of age, and 1525 (8.3%) ≥80 years of age. There was a significantly lower preoperative hemoglobin and estimated glomerular filtration rate with advancing age (p < 0.001). Patients ≥80 had a higher Charlson comorbidity index and World Health Organization (WHO) performance status (p < 0.001). There was also significant variability in the approach to RN (p < 0.001): laparoscopy was most commonly performed (68.8% vs 69.3% vs 75.0%). Patients ≥80 years of age were found to have the shortest operating time (p < 0.001). There were significant differences in T stage between groups with patients ≥80 years of age having a higher T stage (p < 0.001). The incidence of intraoperative complications did not significantly differ between age groups (p = 0.18). The incidence of postoperative complications was 15.7%, 18.2%, and 20.5% and major postoperative complications was 1.4%, 2.1%, and 2.8% in patients <60, 60-79, and ≥80 years of age, respectively (p < 0.001). The most common complication in all age groups was blood transfusion (7.6% <60, 8.6% 60-79, and 9.1% ≥ 80 years of age). Stepwise logistic regression analysis adjusting for additional variables found the odds of a postoperative complication increased with age with an odds ratio of 1.25 in patients ≥80 years of age and an odds ratio of 1.09 in patients 60-70 years of age compared with <60 years of age. Conclusion: Overall complications in all age groups are low, but advancing age should be considered an independent risk factor for postoperative complications after RN and should be appropriately considered when counseling elderly patients before treatment.

Clinical Impact of the Predict Prostate Risk Communication Tool in Men Newly Diagnosed with Nonmetastatic Prostate Cancer: A Multicentre Randomised Controlled Trial.

BACKGROUND: Predict Prostate is a freely available online personalised risk communication tool for men with nonmetastatic prostate cancer. Its accuracy has been assessed in multiple validation studies, but its clinical impact among patients has not hitherto been assessed. OBJECTIVE: To assess the impact of the tool on patient decision-making and disease perception. DESIGN, SETTING, AND PARTICIPANTS: A multicentre randomised controlled trial was performed across eight UK centres among newly diagnosed men considering either active surveillance or radical treatment. A total of 145 patients were included between 2018 and 2020, with median age 67 yr (interquartile range [IQR] 61-72) and prostate-specific antigen 6.8 ng/ml (IQR 5.1-8.8). INTERVENTION: Participants were randomised to either standard of care (SOC) information or SOC and a structured presentation of the Predict Prostate tool. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Validated questionnaires were completed by assessing the impact of the tool on decisional conflict, uncertainty, anxiety, and perception of survival. RESULTS AND LIMITATIONS: Mean Decisional Conflict Scale scores were 26% lower in the Predict Prostate group (mean = 16.1) than in the SOC group (mean = 21.7; p = 0.027). Scores on the "support", "uncertainty", and "value clarity" subscales all favoured Predict Prostate (all p < 0.05). There was no significant difference in anxiety scores or final treatment selection between the two groups. Patient perception of 15-yr prostate cancer-specific mortality (PCSM) and overall survival benefit from radical treatment were considerably lower and more accurate among men in the Predict Prostate group (p < 0.001). In total, 57% of men reported that the Predict Prostate estimates for PCSM were lower than expected, and 36% reported being less likely to select radical treatment. Over 90% of patients in the intervention group found it useful and 94% would recommend it to others. CONCLUSIONS: Predict Prostate reduces decisional conflict and uncertainty, and shifts patient perception around prognosis to be more realistic. This randomised trial demonstrates that Predict Prostate can directly inform the complex decision-making process in prostate cancer and is felt to be useful by patients. Future larger trials are warranted to test its impact upon final treatment decisions. PATIENT SUMMARY: In this national study, we assessed the impact of an individualised risk communication tool, called Predict Prostate, on patient decision-making after a diagnosis of localised prostate cancer. Men were randomly assigned to two groups, which received either standard counselling and information, or this in addition to a structured presentation of the Predict Prostate tool. Men who saw the tool were less conflicted and uncertain in their decision-making, and recommended the tool highly. Those who saw the tool had more realistic perception about their long-term survival and the potential impact of treatment upon this. TAKE HOME MESSAGE: The use of an individualised risk communication tool, such as Predict Prostate, reduces patient decisional conflict and uncertainty when deciding about treatment for nonmetastatic prostate cancer. The tool leads to more realistic perceptions about survival outcomes and prognosis.

Active Surveillance-Is It Feasible for Intermediate-risk Localised Prostate Cancer?

BACKGROUND: Although active surveillance (AS) is a well-recognised treatment option for localised low-risk prostate cancer (LRPC), its role in the management of localised intermediate-risk prostate cancer (IRPC) is not clear yet and the available literature is slightly contradictory. OBJECTIVE: To compare the outcome of AS between LRPC and IRPC patients. DESIGN SETTING AND PARTICIPANTS: Between November 2002 and August 2019, 372 men with localised prostate cancer (PC) underwent AS in our hospital based on local departmental protocol. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome measures were overall survival, disease progression-free survival, treatment-free survival, and biochemical recurrence-free survival. Survival times in the low- and intermediate-risk groups were compared using Cox regression analysis. RESULTS AND LIMITATIONS: Out of 372 localised PC patients, 276 (74%) had LRPC and 96 (26%) IRPC. Overall, 86 (31.2%) low-risk and 25 (26%) intermediate-risk patients developed disease progression, and 86 (31.2%) low-risk and 22 (23%) intermediate-risk patients underwent active treatment. Among the treated patients, eight (2.9%) LRPC patients and one (1%) IRPC patient developed biochemical recurrence. In total, only one patient (from the low-risk group) had metastasis and 25 patients passed away (18 from the low-risk and seven from the intermediate-risk group). No death was recorded due to PC in the cohort. There was no difference in any of the survival outcomes between LRPC and IRPC patients in unadjusted analysis as well as when analysis was performed after adjusting the potentially confounding factors. Limitations include relatively short median follow-up time and failure to objectively define the criteria for the selection of IRPC patients suitable for AS. CONCLUSIONS: The option of AS could be considered for carefully selected and well-informed patients with IRPC provided close structured monitoring is maintained. PATIENT SUMMARY: In this report, we looked at various survival outcomes of active surveillance between low- and intermediate-risk prostate cancer patients in a large British population. There was no difference in any of the survival outcomes between the two groups. We concluded that carefully selected intermediate-risk prostate cancer patients could be offed the option of active surveillance.

Mistaken administration of a repeat loading dose of Degarelix leading to acute psychosis.

Advanced and metastatic prostate cancer is often managed with hormonal blockage. Luteinising hormone-releasing hormone antagonists achieve rapid testosterone suppression and are used for the treatment of advanced or metastatic prostate cancer. Degarelix is a luteinising hormone-releasing hormone antagonist and is given as a loading dose, followed by a monthly maintenance dose. We report a case where a patient was inadvertently given a second loading dose of Degarelix that resulted in acute psychosis in the form of panic attacks, delusions, suicidal thoughts, insomnia and some visual hallucinations, which are not reported as side-effects of Degarelix.

Transdermal oestradiol for androgen suppression in prostate cancer: long-term cardiovascular outcomes from the randomised Prostate Adenocarcinoma Transcutaneous Hormone (PATCH) trial programme.

BACKGROUND: Androgen suppression is a central component of prostate cancer management but causes substantial long-term toxicity. Transdermal administration of oestradiol (tE2) circumvents first-pass hepatic metabolism and, therefore, should avoid the cardiovascular toxicity seen with oral oestrogen and the oestrogen-depletion effects seen with luteinising hormone releasing hormone agonists (LHRHa). We present long-term cardiovascular follow-up data from the Prostate Adenocarcinoma Transcutaneous Hormone (PATCH) trial programme. METHODS: PATCH is a seamless phase 2/3, randomised, multicentre trial programme at 52 study sites in the UK. Men with locally advanced or metastatic prostate cancer were randomly allocated (1:2 from August, 2007 then 1:1 from February, 2011) to either LHRHa according to local practice or tE2 patches (four 100 µg patches per 24 h, changed twice weekly, reducing to three patches twice weekly if castrate at 4 weeks [defined as testosterone ≤1·7 nmol/L]). Randomisation was done using a computer-based minimisation algorithm and was stratified by several factors, including disease stage, age, smoking status, and family history of cardiac disease. The primary outcome of this analysis was cardiovascular morbidity and mortality. Cardiovascular events, including heart failure, acute coronary syndrome, thromboembolic stroke, and other thromboembolic events, were confirmed using predefined criteria and source data. Sudden or unexpected deaths were attributed to a cardiovascular category if a confirmatory post-mortem report was available and as other relevant events if no post-mortem report was available. PATCH is registered with the ISRCTN registry, ISRCTN70406718; the study is ongoing and adaptive. FINDINGS: Between Aug 14, 2007, and July 30, 2019, 1694 men were randomly allocated either LHRHa (n=790) or tE2 patches (n=904). Overall, median follow-up was 3·9 (IQR 2·4-7·0) years. Respective castration rates at 1 month and 3 months were 65% and 93% among patients assigned LHRHa and 83% and 93% among those allocated tE2. 157 events from 145 men met predefined cardiovascular criteria, with a further ten sudden deaths with no post-mortem report (total 167 events in 153 men). 26 (2%) of 1694 patients had fatal cardiovascular events, 15 (2%) of 790 assigned LHRHa and 11 (1%) of 904 allocated tE2. The time to first cardiovascular event did not differ between treatments (hazard ratio 1·11, 95% CI 0·80-1·53; p=0·54 [including sudden deaths without post-mortem report]; 1·20, 0·86-1·68; p=0·29 [confirmed group only]). 30 (34%) of 89 cardiovascular events in patients assigned tE2 occurred more than 3 months after tE2 was stopped or changed to LHRHa. The most frequent adverse events were gynaecomastia (all grades), with 279 (38%) events in 730 patients who received LHRHa versus 690 (86%) in 807 patients who received tE2 (p<0·0001) and hot flushes (all grades) in 628 (86%) of those who received LHRHa versus 280 (35%) who received tE2 (p<0·0001). INTERPRETATION: Long-term data comparing tE2 patches with LHRHa show no evidence of a difference between treatments in cardiovascular mortality or morbidity. Oestrogens administered transdermally should be reconsidered for androgen suppression in the management of prostate cancer. FUNDING: Cancer Research UK, and Medical Research Council Clinical Trials Unit at University College London.