Abstract Background Urinary prostate cancer antigen 3 (PCA3) assay in combination with established clinical risk factors improves the identification of men at risk of harboring prostate cancer (PCa) ...at initial biopsy (IBX). Objective To develop and validate internally the first IBX-specific PCA3-based nomogram that allows an individual assessment of a man's risk of harboring any PCa and high-grade PCa (HGPCa). Design, setting, and participants Clinical and biopsy data including urinary PCA3 score of 692 referred IBX men at risk of PCa were collected within two prospective multi-institutional studies. Intervention IBX (≥10 biopsy cores) with standard risk factor assessment including prebiopsy urinary PCA3 measurement. Outcome measurements and statistical analysis PCA3 assay cut-off thresholds were investigated. Regression coefficients of logistic risk factor analyses were used to construct specific sets of PCA3-based nomograms to predict any PCa and HGPCa at IBX. Accuracy estimates for the presence of any PCa and HGPCa were quantified using area under the curve of the receiver operator characteristic analysis and compared with a clinical model. Bootstrap resamples were used for internal validation. Decision curve analyses quantified the clinical net benefit related to the novel PCA3-based IBX nomogram versus the clinical model. Results and limitations Any PCa and HGPCa were diagnosed in 46% ( n = 318) and 20% ( n = 137), respectively. Age, prostate-specific antigen, digital rectal examination, prostate volume, and PCA3 were independent predictors of PCa at IBX (all p < 0.001). The PCA3-based IBX nomograms significantly outperformed the clinical models without PCA3 (all p < 0.001). Accuracy was increased by 4.5–7.1% related to PCA3 inclusion. When applying nomogram-derived PCa probability thresholds ≤30%, only a few patients with HGPCa (≤2%) will be missed while avoiding up to 55% of unnecessary biopsies. External validation of the PCA3-based IBX-specific nomogram is warranted. Conclusions The internally validated PCA3-based IBX-specific nomogram outperforms a clinical prediction model without PCA3 for the prediction of any PCa, leading to the avoidance of unnecessary biopsies while missing only a few cases of HGPCa. Our findings support the concepts of a combination of novel markers with established clinical risk factors and the superiority of decision tools that are specific to a clinical scenario.
Abstract Context Partial nephrectomy (PN) is the current gold standard treatment for small localized renal tumors.; however, the impact of duration and type of intraoperative ischemia on renal ...function (RF) after PN is a subject of significant debate. Objective To review the current evidence on the relationship of intraoperative ischemia and RF after PN. Evidence acquisition A review of English-language publications on renal ischemia and RF after PN was performed from 2005 to 2014 using the Medline, Embase, and Web of Science databases. Ninety-one articles were selected with the consensus of all authors and analyzed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Evidence synthesis The vast majority of reviewed studies were retrospective, nonrandomized observations. Based on the current literature, RF recovery after PN is strongly associated with preoperative RF and the amount of healthy kidney parenchyma preserved. Warm ischemia time (WIT) is modifiable and prolonged warm ischemia is significantly associated with adverse postoperative RF. Available data suggest a benefit of keeping WIT <25 min, although the level of evidence to support this threshold is limited. Cold ischemia safely facilitates longer durations of ischemia. Surgical techniques that minimize or avoid global ischemia may be associated with improved RF outcomes. Conclusions Although RF recovery after PN is strongly associated with quality and quantity of preserved kidney, efforts should be made to limit prolonged WIT. Cold ischemia should be preferred when longer ischemia is expected, especially in presence of imperative indications for PN. Additional research with higher levels of evidence is needed to clarify the optimal use of renal ischemia during PN. Patient summary In this review of the literature, we looked at predictors of renal function after surgical resection of renal tumors. There is a strong association between the quality and quantity of renal tissue that is preserved after surgery and long-term renal function. The time of interruption of renal blood flow during surgery is an important, modifiable predictor of postoperative renal function.
Summary Background The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to ...assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. Methods This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen (PSA) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160 mg/day. The primary outcome was the proportion of patients with an 80% or greater decline in PSA at week 25. All analyses included all patients who had received at least one dose of the study drug. This study is registered with ClinicalTrials.gov , number NCT01302041. Findings 67 men were enrolled into the study. 62 patients (92·5%, 95% CI 86·2–98·8) had a decline in PSA of 80% or greater at week 25. The most commonly reported treatment-emergent adverse events up to week 25 were gynaecomastia (n=24), fatigue (n=23), nipple pain (n=13), and hot flush (n=12), all of which were of mild to moderate severity. Nine patients had a treatment-emergent adverse event of grade 3 or higher, most of which were reported in one patient each, except for pneumonia (grade 3, two patients) and hypertension (grade 3, four patients). Five patients reported serious adverse events, none of which were deemed to be treatment related. Interpretation Our findings suggest that enzalutamide monotherapy in men with hormone-naive prostate cancer of varying severity provides a level of disease suppression, and was generally well tolerated. These findings provide a rationale for further investigation of clinical response and outcomes with enzalutamide in non-castrate men with prostate cancer. Funding Astellas Pharma Inc, Medivation Inc.
Several retrospective and a few prospective studies have shown that metastasis-directed therapy (MDT) could delay clinical progression and postpone the initiation of systemic treatment in ...oligorecurrent prostate cancer (PCa) patients. However, these endpoints are strongly influenced by variables such as concomitant use of androgen deprivation therapy (ADT) and follow-up imaging protocols. The aim of this manuscript was to assess palliative ADT- and metastatic castration-resistant prostate cancer (mCRPC)-free survival as long-term oncological outcomes in oligorecurrent PCa treated by MDT. We retrospectively identified consecutive post-prostatectomy oligorecurrent PCa patients treated by MDT (salvage lymphadenectomy, radiotherapy, or metastasectomy) at our tertiary referral center. Patients were eligible for inclusion if they developed recurrence following radical prostatectomy, had ≤5 metastatic lesions on imaging and had a serum testosterone >50 ng/dL or a testosterone suppression therapy-free interval of >2 years prior to the first MDT as an assumption of recovered serum testosterone (if no testosterone measurement available). Patients with castration-resistant or synchronous oligometastatic PCa at the time of first MDT were excluded. Repeated MDTs were allowed, as well as a period of concomitant ADT. Kaplan-Meier analyses were performed to assess palliative ADT-free and mCRPC-free survival. We identified 191 eligible patients who underwent MDT. Median follow-up from first MDT until last follow-up or death was 45 months (IQR 27-70; mean 51 months). Estimated median palliative-ADT free survival was 66 months (95% CI 58-164) and estimated median mCRPC-free survival was not reached (mean 117 months, 95% CI 103-132). In total, 314 MDTs were performed and 25 patients (13%) received ≥3 MDTs. This study demonstrated that (repeated) MDT is feasible and holds promise in terms of palliative ADT-free and mCRPC-free survival for patients with oligorecurrent PCa. However, these findings should be confirmed in prospective randomized controlled trials.
Telemedicine provides remote clinical support using technological tools. It may facilitate health care delivery while reducing unnecessary visits to the clinic. The coronavirus disease 2019 ...(COVID-19) outbreak has caused an abrupt change in our daily urological practice, converting many of us to be reliant on telehealth.
To provide practical recommendations for effective use of technological tools in telemedicine.
A Medline-based and gray literature search was conducted through April 2020. We selected the most relevant articles related to “telemedicine” and “smart working” that could provide important information.
Telemedicine refers to the use of electronic information and telecommunications tools to provide remote clinical health care support. Smart working is a model of work that uses new or existing technologies to improve performance. Telemedicine is becoming a useful invaluable tool during and even beyond the COVID-19 pandemic. It is time for us to formalize the place of telemedicine in routine urological practice, and it is our responsibility to adapt and learn about all the tools and possible strategies for their optimal implementation during the pandemic to ensure that the quality of care received by patients and the outcomes of patients and their families are of the highest standard.
Telemedicine facilitates specialized urological clinical support at a distance, solves problems of limitations in mobility, reduces unnecessary visits to clinics, and is useful for reducing the risk of viral transmission in the current COVID-19 outbreak. Furthermore, both personal and societal considerations may favor continued use of telemedicine, even beyond the COVID-19 pandemic.
Telemedicine in urology offers specialized remote clinical support to patients, similar to face-to-face visits. It is very useful for reducing unnecessary visits to the clinic, as well as reducing the risk of contagion in the current coronavirus disease 2019 (COVID-19) pandemic.
Telemedicine facilitates specialized urological clinical support at a distance, solves problems of limitations in mobility, reduces unnecessary visits to clinics, and is useful for reducing the risk of viral transmission in the current coronavirus disease 2019 (COVID-19) outbreak.
Abstract Context Despite the wide diffusion of laparoscopic radical prostatectomy (LRP) and robot-assisted laparoscopic radical prostatectomy (RALP), only few studies comparing the results of these ...techniques with the retropubic radical prostatectomy (RRP) are currently available. Objective To evaluate the perioperative, functional, and oncologic results in the comparative studies evaluating RRP, LRP, and RALP. Evidence acquisition A systematic review of the literature was performed in January 2008, searching Medline, Embase, and Web of Science databases. A “free-text” protocol using the term radical prostatectomy was applied. Some 4000 records were retrieved from the Medline database; 2265 records were retrieved from the Embase database;, and 4219 records were retrieved from the Web of Science database. Three of the authors reviewed the records to identify comparative studies. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK). Evidence synthesis Thirty-seven comparative studies were identified in the literature search, including a single, randomised, controlled trial. With regard to the perioperative outcome, LRP and RALP were more time consuming than RRP, especially in the initial steps of the learning curve, but blood loss, transfusion rates, catheterisation time, hospitalisation duration, and complication rates all favoured LRP. With regard to the functional results, LRP and RRP showed similar continence and potency rates. Similarly, no significant differences were identified between LRP and RALP, while a single, nonrandomised, prospective study suggested advantages in terms of both continence and potency recovery after RALP, compared with RRP. With regard to the oncologic outcome, LRP and RALP were associated with positive surgical margin rates similar to those of RRP. Conclusions The quality of the available comparative studies was not excellent. LRP and RALP are followed by significantly lower blood loss and transfusion rates, but the available data were not sufficient to prove the superiority of any surgical approach in terms of functional and oncologic outcomes. Further high-quality, prospective, multicentre, comparative studies are needed.
With the introduction of new anatomical and functional imaging modalities, mainly positron emission tomographycomputed tomography (PET-CT) and multi-parametric magnetic resonance imaging, the ...eventual origin of biochemical recurrence after curative treatment for prostate cancer can be detected at its earliest stage. Targeted treatment strategies to this local or oligometastatic relapse will be successful in postponing the initiation of systemic treatment, thereby delaying the occurrence of the castrate resistant state and, eventually, improve survival.
Objective
To determine the number of cases a urological surgeon must complete to achieve proficiency for various urological procedures.
Patient and Methods
The MEDLINE, EMBASE and PsycINFO databases ...were systematically searched for studies published up to December 2011.
Studies pertaining to learning curves of urological procedures were included.
Two reviewers independently identified potentially relevant articles.
Procedure name, statistical analysis, procedure setting, number of participants, outcomes and learning curves were analysed.
Results
Forty‐four studies described the learning curve for different urological procedures.
The learning curve for open radical prostatectomy ranged from 250 to 1000 cases and for laparoscopic radical prostatectomy from 200 to 750 cases.
The learning curve for robot‐assisted laparoscopic prostatectomy (RALP) has been reported to be 40 procedures as a minimum number.
Robot‐assisted radical cystectomy has a documented learning curve of 16–30 cases, depending on which outcome variable is measured.
Irrespective of previous laparoscopic experience, there is a significant reduction in operating time (P = 0.008), estimated blood loss (P = 0.008) and complication rates (P = 0.042) after 100 RALPs.
Conclusions
The available literature can act as a guide to the learning curves of trainee urologists. Although the learning curve may vary among individual surgeons, a consensus should exist for the minimum number of cases to achieve proficiency.
The complexities associated with defining procedural competence are vast.
The majority of learning curve trials have focused on the latest surgical techniques and there is a paucity of data pertaining to basic urological procedures.
Abstract Context Despite the large diffusion of robot-assisted radical prostatectomy (RARP), literature and data on the oncologic outcome of RARP are limited. Objective Evaluate lymph node yield, ...positive surgical margins (PSMs), use of adjuvant therapy, and biochemical recurrence (BCR)–free survival following RARP and perform a cumulative analysis of all studies comparing the oncologic outcomes of RARP and retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). Evidence acquisition A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK) and Stata 11.0 SE software (StataCorp, College Station, TX, USA). Evidence synthesis We retrieved 79 papers evaluating oncologic outcomes following RARP. The mean PSM rate was 15% in all comers and 9% in pathologically localized cancers, with some tumor characteristics being the most relevant predictors of PSMs. Several surgeon-related characteristics or procedure-related issues may play a major role in PSM rates. With regard to BCR, the very few papers with a follow-up duration >5 yr demonstrated 7-yr BCR-free survival estimates of approximately 80%. Finally, all the cumulative analyses comparing RARP with RRP and comparing RARP with LRP demonstrated similar overall PSM rates (RARP vs RRP: odds ratio OR: 1.21; p = 0.19; RARP vs LRP: OR: 1.12; p = 0.47), pT2 PSM rates (RARP vs RRP: OR: 1.25; p = 0.31; RARP vs LRP: OR: 0.99; p = 0.97), and BCR-free survival estimates (RARP vs RRP: hazard ratio HR: 0.9; p = 0.526; RARP vs LRP: HR: 0.5; p = 0.141), regardless of the surgical approach. Conclusions PSM rates are similar following RARP, RRP, and LRP. The few data available on BCR from high-volume centers are promising, but definitive comparisons with RRP or LRP are not currently possible. Finally, significant data on cancer-specific mortality are not currently available.
Abstract Context Perioperative complications are a major surgical outcome for radical prostatectomy (RP). Objective Evaluate complication rates following robot-assisted RP (RARP), risk factors for ...complications after RARP, and surgical techniques to improve complication rates after RARP. We also performed a cumulative analysis of all studies comparing RARP with retropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications. Evidence acquisition A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK). Evidence synthesis We retrieved 110 papers evaluating oncologic outcomes following RARP. Overall mean operative time is 152 min; mean blood loss is 166 ml; mean transfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stay is 1.9 d. The mean complication rate was 9%, with most of the complications being of low grade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are the most prevalent surgical complications. Blood loss (weighted mean difference: 582.77; p < 0.00001) and transfusion rate (odds ratio OR: 7.55; p < 0.00001) were lower in RARP than in RRP, whereas only transfusion rate (OR: 2.56; p = 0.005) was lower in RARP than in LRP. All the other analyzed parameters were similar, regardless of the surgical approach. Conclusions RARP can be performed routinely with a relatively small risk of complications. Surgical experience, clinical patient characteristics, and cancer characteristics may affect the risk of complications. Cumulative analyses demonstrated that blood loss and transfusion rates were significantly lower with RARP than with RRP, and transfusion rates were lower with RARP than with LRP, although all other features were similar regardless of the surgical approach.
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