Prognostic factors in post-prostatectomy salvage radiotherapy setting with and without hormonotherapy: An individual patient data analysis of randomized trials from ICECaP database.

BACKGROUND: Early salvage radiotherapy (SRT) is the standard of care for biochemical recurrence post-prostatectomy but outcomes are heterogeneous. OBJECTIVE: To develop a risk scoring system based on relevant standard-of-care clinico-pathological prognostic factors for patients treated with SRT with and without hormonal therapy (HT). DESIGN, SETTING, AND PARTICIPANTS: The Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) database included three randomized trials (Individual patients' data from 1647 subjects) assessing SRT (GETUG-AFU-16; NRG/RTOG-9601, and a subset of EORTC-22911). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Outcomes were clinical progression (CP). metastasis free-survival (MFS) and overall survival (OS). Clinico-pathological factors, including pathological Gleason Score (GS), PSA at SRT start, margin status, persistent PSA post-RP and time from RP to SRT were evaluated by multivariable models stratified by type of treatment. RESULTS AND LIMITATIONS: On multivariable analysis PSA ≥ 0.5 ng/mL at SRT start, GS ≥ 8 and negative margin status were the three strongest prognostic factors. Three prognostic groups defined by number of these risk features (high risk: 2 or 3; intermediate risk: 1 and low risk: 0) were strongly associated with OS, MFS and CP outcomes with SRT alone or with HT. This prognostic group definition was also relevant for patients with persistent PSA post RP and for patients treated < 1 year from RP to SRT and with and without HT. CONCLUSION: A risk score for patients receiving SRT with or without HT, using three standard-of-care clinico-pathological risk factors provides refined prognostic information for individual patient counselling. PATIENT SUMMARY: By using a composite score of pathology grading (Gleason Score), PSA at start of salvage radiation and margin status data, physicians can provide patients with more refined information on the risk of a second relapse after receiving radiation to the prostate bed after a prostatectomy for a rising or persistent PSA, both with and without hormonal therapy.

Effect of Radical Prostatectomy on Survival for Men with High-risk Nonmetastatic Prostate Cancer Features Selected According to STAMPEDE Criteria: An EMPaCT Study.

BACKGROUND AND OBJECTIVE: A meta-analysis of two randomized STAMPEDE platform trials revealed that 3 yr of abiraterone acetate in addition to androgen deprivation therapy and radiation therapy significantly improved metastasis-free and overall survival (OS) in high-risk nonmetastatic prostate cancer (PCa) and should be considered a new standard of care. The aim of our study was to assess long-term cancer-specific survival (CSS) and OS for surgically treated patients with newly diagnosed nonmetastatic node-negative PCa meeting the STAMPEDE criteria for high risk. METHODS: This was a retrospective, multicenter cohort study of patients with European Association of Urology (EAU) high-risk PCa who underwent radical prostatectomy and extended pelvic lymph node dissection. CSS was assessed using cumulative incidence curves and the Kaplan-Meier method was used to evaluate OS. We used a Fine and Gray model to evaluate the prognostic value of STAMPEDE high-risk factors (SHRFs) for CSS, and a Cox proportional-hazards model to assess the association of SHRFs with OS. KEY FINDINGS AND LIMITATIONS: A total of 2994 patients with EAU high-risk PCa were divided into groups with 0, 1, 2, or 3 SHRFs. The 10-yr survival estimates for patients with 0-1 versus 2-3 SHRFs were 95% versus 82% for CSS and 81% versus 64% for OS (both p < 0.0001). In comparison to patients with 0 SHRFs, hazard ratios were 1.2 (p = 0.5), 3.9 (p < 0.0001), and 5.5 (p < 0.0001) for CSS, and 1.1 (p = 0.4), 2.2 (p < 0.0001), and 2.5 (p = 0.0004) for OS for patients with 1, 2, and 3 SHRFs, respectively. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our results confirm that the STAMPEDE high-risk criteria identify a subgroup of patients with highly aggressive PCa features and adverse long-term oncological outcomes. This population is likely to benefit most from aggressive multimodal treatment. Nevertheless, we have shown for the first time that surgery remains a viable treatment option for patients with STAMPEDE high-risk PCa. PATIENT SUMMARY: Prostate cancer that meets the high-risk definitions from the STAMPEDE trial is an aggressive type of cancer. Our results for long-term cancer control outcomes indicate that surgery is a viable option for the subgroup of patients with this type of prostate cancer.

Risk of Cancer-related Death for Men with Biopsy Grade Group 1 Prostate Cancer and High-risk Features: A European Multi-institutional Study.

International Society of Urological Pathology grade group 1 (GG 1) prostate cancer (PCa) is generally considered insignificant, with recent suggestions that it should even be considered as "noncancerous". We evaluated outcomes for patients with GG 1 PCa on biopsy (bGG 1) and high-risk features (prostate-specific antigen [PSA] >20 ng/ml and/or cT3-4 stage) to challenge the hypothesis that every case of bGG 1 PCa has a benign disease course. We used the multi-institutional EMPaCT database, which includes data for 9508 patients with high-risk PCa undergoing surgery. We included patients with bGG 1 PCa (n = 848) in our analysis and divided them into three groups according to PSA >20 ng/ml, cT3-4 stage, or both. The estimated 10-yr cancer-specific survival (CSS) rate was 96% in the overall population, 88% in the group with both PSA >20 ng/ml and cT3-4 stage, 97% in the group with PSA >20 ng/ml alone, and 98% in the group with cT3-4 stage alone. Similar CSS outcomes were found in subgroups with GG 1 PCa on pathology (n = 502) and with GG 1 on biopsy diagnosed after 2005 (n = 253). Study limitations include the lack of magnetic resonance imaging (MRI) staging and MRI-targeted biopsies. In conclusion, patients with GG 1 and either PSA >20 ng/ml or cT3-4 stage have a low risk of dying from their cancer after surgery. However, patients with GG 1 PCa and both PSA >20 ng/ml and cT3-4 stage are at higher risk of cancer-specific mortality and active treatment should be discussed for this subgroup. Patient summary: We assessed outcomes for patients diagnosed with low-grade prostate cancer on biopsy who also had one or two factors associated with high risk disease. Men with both of those risk factors had a higher risk of dying from their prostate cancer. Active treatment should be discussed for this subgroup of patients.

Understanding the Barriers to Prostate Cancer Population-Based Early Detection Programs: The PRAISE-U BEST Survey.

In 2022, the European Commission updated its recommendation on cancer screening, inviting the Member States (MSs) to explore the feasibility of stepwise implementation of population-based screening for prostate cancer (PCa). In line with this recommendation, the PRAISE-U (Prostate Cancer Awareness and Initiative for Screening in the European Union (EU)) project was initiated. As part of the PRAISE-U, we aim to understand the current practice towards early detection in the EU MSs, the barriers to implementing or planning population-based screening programmes, and potential solutions to overcome these barriers. METHODS: We adapted the Barriers to Effective Screening Tool (BEST) survey to the PCa context. However, it has not been validated in this context. We translated it into all spoken languages in the EU27 and disseminated it to different stakeholders across the EU using a snowballing approach. RESULTS: We received 410 responses from 55 countries, of which 301 (73%) were from the 27 EU MSs. The most represented stakeholder group was urologists (218 (54%)), followed by general practitioners (GPs) (83 (21%)), patient representatives (35 (9%)), policy stakeholders (27 (7%)), researchers (23 (6%)), oncologists, pathologists, radiologists, nurses, and others (16 (4%)) and one industry representative. Among all respondents, 286 (69%) reported the absence of a population-based screening programme, mainly attributed to resource limitations and a lack of political and medical society support. Out of these 286 respondents, 196 (69%) indicated that opportunistic screening is being applied in their country, and 199 (70%) expressed their support for population-based screening programmes (which was highest amongst patient representatives and urologists and lowest amongst GPs and policy stakeholders). The highest scored barriers were lack of political support, insufficient operational resources, and inadequate participation. Suggested solutions to overcome these included awareness campaigns, consensus meetings, political lobbying and European guidelines (to overcome political support barriers), compatible IT systems (to overcome operational barriers), and easy access (to overcome participation barriers). CONCLUSIONS: Participants have noted the presence of opportunistic screening, and particularly urologists and patient representatives expressed their support for the establishment of a population-based PCa screening programme. Nevertheless, successful implementation of population-based screening programmes is complex; it requires political and medical society support, operational resources and capacity, awareness campaigns, as well as the development of protocols, guidelines, and legal frameworks.

Health Policy for Prostate Cancer Early Detection in the European Union and the Impact of Opportunistic Screening: PRAISE-U Consortium.

With the new policy recommendation in 2022 to explore the possibilities of screening for prostate cancer by the European Commission, the landscape for prostate cancer early detection is evolving. In line with this recommendation, the PRAISE-U project aims to evaluate the early detection and diagnosis of prostate cancer through customised and risk-based screening programmes, with the goal to align protocols across European Union member states. This systematic review is part of the PRAISE-U project, with the goal to review the policy, medical guideline recommendations, and the current level of opportunistic screening presented in the scientific literature on prostate cancer early detection from 2016 to 2023 in European Union member states. An extensive literature search was performed on 1 June 2023 in a large number of databases, including Embase.com, Medline (Ovid), Web of Science Core Collection, Google Scholar, and Policy Commons. We identified 318 articles (qualitative, quantitative, and reviews), of which 41 were included in the full-text screening. Seventeen articles were ultimately identified as eligible for inclusion. The included articles revealed significant variations towards PSA-based early detection policies for prostate cancer in nine European countries. Despite official recommendations, opportunistic screening was prevalent across all nine countries regardless of recommendations for or against PSA-based early detection. This systematic review suggests that the current early detection policies are not fit for purpose. High levels of opportunistic screening and overdiagnosis persist, prompting policy recommendations for standardised guidelines, informed decision making, and increased awareness to improve efficiency and effectiveness in early detection.

Impact of the Standardization of Penile Cancer Care on the Quality of Care, Outcomes, and Academic-driven Centralization in a Single eUROGEN Referral Center.

BACKGROUND: Penile cancer (PeCa) represents a diagnostic and therapeutic challenge given the low patient volume, which may result in inadequate physician expertise and poor guideline adherence. Since 2015, we have developed a specific care pathway for PeCa in our tertiary referral center. OBJECTIVE: To evaluate the impact of a dedicated PeCa care pathway on patient management, the adequacy of pathological reporting, and oncological outcomes. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively queried our institutional registry (S-66482) to identify patients who were surgically treated for PeCa between January 1989 and April 2022. The patient numbers were evaluated within a broader national context. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We compared patient, surgery, tumor, and pathological data before and after 2015. Kaplan-Meier analysis was used to compare local and regional recurrence rates and cancer-specific survival (CSS). RESULTS AND LIMITATIONS: Overall, 313 patients were included, of whom 204 (65.1%) were surgically treated after 2015. The median number of patients treated yearly was significantly higher after 2015 (26 vs 5; p < 0.01). Patients treated after 2015 more frequently had no palpable lymph nodes at diagnosis, despite similar primary tumor stage. After adoption of the PeCa care pathway, organ-sparing surgery (OSS) was more commonly performed (79.9% vs 57.8%; p < 0.01) despite local staging being similar and without observing a significant increase in positive margins. Surgical staging in patients with European Association of Urology intermediate- or high-risk tumors was conducted more frequently after 2015 (90% vs 41%; p < 0.01). Pathology reporting was standardized, and there was more frequent reporting of p16 staining status (81.4% vs 8.3%; p < 0.01), lymphovascular invasion (93.8% vs 44.3%; p < 0.01), and perineural invasion (92.4% vs 44.3%; p < 0.01) following implementation. CONCLUSIONS: Implementation of a standardized care pathway for PeCa resulted in higher rates of OSS and pathological nodal staging and more complete pathology reports. Considering that these changes were associated with an increase in the number of patients treated, academic-driven centralization may play a role in optimizing the management of these patients. PATIENT SUMMARY: We evaluated the impact of a care pathway for patients with penile cancer on patient management, the completeness of pathology reporting, and cancer control. We found that implementation of this pathway was associated with an increase in the number of patients treated, higher rates of organ-sparing surgery and lymph node staging, and more complete pathology reports. Centralization of care may play a role in optimizing the management of penile cancer.

Early Detection of Prostate Cancer in the European Union: Combining Forces with PRAISE-U.

The European Association of Urology, together with consortium partners, has launched PRAISE-U (Prostate Cancer Awareness and Initiative for Screening in the European Union), a project involving 25 institutions across 12 countries that is funded under the EU4Health program. The aim is to reduce the morbidity and mortality of prostate cancer in EU member states via customized and risk-based screening programs.

Diabetes, Obesity, and Pathological Upstaging in Renal Cell Carcinoma: Results From a Large Multi-institutional Consortium.

PURPOSE: We sought to determine whether clinical risk factors and morphometric features on preoperative imaging can be utilized to identify those patients with cT1 tumors who are at higher risk of upstaging (pT3a). MATERIALS AND METHODS: We performed a retrospective international case-control study of consecutive patients treated surgically with radical or partial nephrectomy for nonmetastatic renal cell carcinoma (cT1 N0) conducted between January 2010 and December 2018. Multivariable logistic regression models were used to study associations of preoperative risk factors on pT3a pathological upstaging among all patients, as well as subsets with those with preoperative tumors ≤4 cm, renal nephrometry scores, tumors ≤4 cm with nephrometry scores, and clear cell histology. We also examined association with pT3a subsets (renal vein, sinus fat, perinephric fat). RESULTS: Among the 4,092 partial nephrectomy and 2,056 radical nephrectomy patients, pathological upstaging occurred in 4.9% and 23.3%, respectively. Among each group independent factors associated with pT3a upstaging were increasing preoperative tumor size, increasing age, and the presence of diabetes. Specifically, among partial nephrectomy subjects diabetes (OR=1.65; 95% CI 1.17, 2.29), male sex (OR=1.62; 95% CI 1.14, 2.33), and increasing BMI (OR=1.03; 95% CI 1.00, 1.05 per 1 unit BMI) were statistically associated with upstaging. Subset analyses identified hilar tumors as more likely to be upstaged (partial nephrectomy OR=1.91; 95% CI 1.12, 3.16; radical nephrectomy OR=2.16; 95% CI 1.44, 3.25). CONCLUSIONS: Diabetes and higher BMI were associated with pathological upstaging, as were preoperative tumor size, increased age, and male sex. Similarly, hilar tumors were frequently upstaged.

Morbidity of elective surgery for localized renal masses among elderly patients: A contemporary multicenter study.

BACKGROUND: The aging population and the incidence of renal cell carcinoma (RCC) are increasing worldwide. Over 25% of newly diagnosed LRM (localized renal masses) occur in patients over the eighth decade of life. The decision-making and treatment approach to LRM in this population represents a clinical dilemma due to inherited decreased functional reserve and competing mortality risks. Current literature reports conflicting evidence regarding age as a risk factor for worst surgical outcomes. As such, we aimed to evaluate the contemporary morbidity of elective surgery for LRM among elderly patients, focusing on intraoperative and postoperative complications. METHODS: After Ethical Committee approval, we queried our prospectively maintained databases to identify patients with preoperative eGFR ≥60 ml/min/1.73 m [(David and Bloom, 2022) 22 and a normal contralateral kidney who underwent partial or radical nephrectomy (PN or RN) for a single cT1-T2N0M0 LRM between 1/2015-12/2021 at four high-volume European Academic Institutions. Patients were categorized by age groups: <50 yrs (young) vs. 50-75 (middle-aged) yrs vs.> 75 yrs (elderly). Postoperative complications were recorded according to Clavien-Dindo (CD) classification. The primary objectives were the proportion of patients experiencing intraoperative (IOC), any grade (AGC), and high-grade postoperative complications (HGC), defined as CD grade 3-5. RESULTS: Overall, 2469/3076 (80.2%) patients met the inclusion criteria. Of these, 363 (14.7%) were young, 1682 (68.1%) were middle-aged, and 424 (17.2%) were elderly. Compared to middle-aged and young patients, elderly patients had a higher median Charlson Comorbidity Index (6 vs. 4 vs. 0, p < 0.01) and a higher proportion of cT1 renal mass (87.6% vs. 93.0% vs. 93.6%, p < 0.01). No differences among the study groups were found regarding surgical approach (open vs. minimally-invasive) and type of surgery (PN vs. RN). We found that older patients experienced similar IOC (4.5% vs. 4.2% vs. 3.3%, p = 0.7) and AGC (23.1% vs. 20.0% vs. 21.5%, p = 0.4) compared to middle-aged and young patients, respectively. Similarly, there were no significant differences in HGC between the study cohorts (0.7% vs. 1.4% vs. 1.7%, p = 0.8). At multivariable analysis, open approach and PN significantly predicted the occurrence of AGCs, while only the open surgical approach was associated with the occurrence of HGCs. CONCLUSION: In kidney cancer tertiary referral centers, the risk of IOC and postoperative HGC after PN or RN for localized renal masses (LRM) is low, despite a non-negligible risk of AGC, especially in elderly patients. Further efforts should focus on identifying multidisciplinary strategies to select patients most likely to benefit from surgery among elderly candidates with LRMs and decrease the morbidity of surgery in this specific setting.

How to follow the new EU Council recommendation and improve prostate cancer early detection: the Prostaforum 2022 declaration.

An updated Council of the EU recommendation on cancer screening was adopted in December 2022 during the Czech EU presidency. The recommendation included prostate cancer as a suitable target disease for organised screening, and invited countries to proceed with piloting and further research. To support further discussions and actions to promote early detection of prostate cancer, an international conference in November 2022 (Prostaforum 2022) resulted in a joint declaration. Here we describe the EU policy background, summarise the preparation of the declaration and the key underlying evidence and expert recommendations, and report the text of the declaration. The declaration summarises the striking inequalities in prostate cancer burden in Europe and calls on all stakeholders to consider and support concrete steps for advancement of organised early detection of prostate cancer. Our aim is to request endorsement of the text and potential initiation of practical actions by all stakeholders to support the aims of the declaration. Patient summary: Prostate cancer is among the most frequent cancers and is one of the most common causes of cancer death among men. The European Union has recommended new pilot programmes for prostate cancer screening. The Prostaforum 2022 declaration invites all stakeholders to support this new recommendation with specific steps.

New-onset Chronic Kidney Disease After Surgery for Localised Renal Masses in Patients with Two Kidneys and Preserved Renal Function: A Contemporary Multicentre Study.

Background: There is a lack of evidence on acute kidney injury (AKI) and new-onset chronic kidney disease (CKD) after surgery for localised renal masses (LRMs) in patients with two kidneys and preserved baseline renal function. Objective: To evaluate the prevalence and risk of AKI and new-onset clinically significant CKD (csCKD) in patients with a single renal mass and preserved renal function after being treated with partial (PN) or radical (RN) nephrectomy. Design setting and participants: We queried our prospectively maintained databases to identify patients with a preoperative estimated glomerular filtration rate (eGFR) of ≥60 ml/min/1.73 m2 and a normal contralateral kidney who underwent PN or RN for a single LRM (cT1-T2N0M0) between January 2015 and December 2021 at four high-volume academic institutions. Intervention: PN or RN. Outcome measurements and statistical analysis: The outcomes of this study were AKI at hospital discharge and the risk of new-onset csCKD, defined as eGFR <45 ml/min/1.73 m2, during the follow-up. Kaplan-Meier curves were used to examine csCKD-free survival according to tumour complexity. A Multivariable logistic regression analysis assessed the predictors of AKI, while a multivariable Cox regression analysis assessed the predictors of csCKD. Sensitivity analyses were performed in patients who underwent PN. Results and limitations: Overall, 2469/3076 (80%) patients met the inclusion criteria. At hospital discharge, 371/2469 (15%) developed AKI (8.7% vs 14% vs 31% in patients with low- vs intermediate- vs high-complexity tumours, p < 0.001). At the multivariable analysis, body mass index, history of hypertension, tumour complexity, and RN significantly predicted the occurrence of AKI. Among 1389 (56%) patients with complete follow-up data, 80 events of csCKD were recorded. The estimated csCKD-free survival rates were 97%, 93% and 86% at 12, 36, and 60 mo, respectively, with significant differences between patients with high- versus low-complexity and high- versus intermediate-complexity tumours (p = 0.014 and p = 0.038, respectively). At the Cox regression analysis, age-adjusted Charlson Comorbidity Index, preoperative eGFR, tumour complexity, and RN significantly predicted the risk of csCKD during the follow-up. The results were similar in the PN cohort. The main limitation of the study was the lack of data on eGFR trajectories within the 1st year after surgery and on long-term functional outcomes. Conclusions: The risk of AKI and de novo csCKD in elective patients with an LRM and preserved baseline renal function is not clinically negligible, especially in those with higher-complexity tumours. While baseline nonmodifiable patient/tumour-related characteristics modulate this risk, PN should be prioritised over RN to maximise nephron preservation if oncological outcomes are not jeopardised. Patient summary: In this study, we evaluated how many patients with a localised renal mass and two functioning kidneys, who were candidates for surgery at four referral European centres, experienced acute kidney injury at hospital discharge and significant renal functional impairment during the follow-up. We found that the risk of acute kidney injury and clinically significant chronic kidney disease in this patient population is not negligible, and was associated with specific baseline patient comorbidities, preoperative renal function, tumour anatomical complexity, and surgery-related factors, in particular the performance of radical nephrectomy.

Radioligand therapies in cancer: mapping the educational landscape in Europe.

AIM: We performed a systematic survey to assess the existing gaps in Europe in multidisciplinary education for integration of radioligand therapy (RLT) into cancer care and to obtain detailed information on the current limitations and key contents relevant. METHODS: A high-quality questionnaire, with emphasis on survey scales, formulation, and validity of the different items, was designed. An expert validation process was undertaken. The survey was circulated among medical specialties involved in cancer treatment, universities, and nursing organizations. Questionnaires (156) were distributed, and 95 responses received. RESULTS: Sevety-eight percent of medical societies indicated that training in RLT was very important and 12% important. Eighty-eight percent indicated that their specialty training program included RLT. Twenty-six percent were satisfied with the existing structure of training in RLTs. Ninety-four percent indicated that the existing training is based on theory and hands-on experience. Main identified limitations were lack of centers ready to train and of personnel available for teaching. Sixty-five percent indicated that national programs could be expanded. Fifty percent of consulted universities indicated partial or scarce presence of RLT contents in their teaching programs. In 26% of the cases, the students do not have the chance to visit a RLT facility. A large majority of the universities are interested in further expansion of RLT contents in their curriculums. Nursing organizations almost never (44.4%) or occasionally (33.3%) include RLT contents in the education of nurses and technologists. Hands-on experience is almost never (38%) and sometimes (38%) offered. However, 67% of centers indicated high interest in expanding RLT contents. CONCLUSION: Centers involved recognize the importance of the training and indicate a need for inclusion of additional clinical content, imaging analysis, and interpretation as well as extended hands-on training. A concerted effort to adapt current programs and a shift towards multidisciplinary training programs is necessary for proper education in RLT in Europe.

Estimating Postoperative Renal Function After Surgery for Nonmetastatic Renal Masses: A Systematic Review of Available Prediction Models.

CONTEXT: A variety of models predicting postoperative renal function following surgery for nonmetastatic renal tumors have been reported, but their validity and clinical usefulness have not been formally assessed. OBJECTIVE: To summarize prediction models available for estimation of mid- to long-term (>3 mo) postoperative renal function after partial nephrectomy (PN) or radical nephrectomy (RN) for nonmetastatic renal masses that include only preoperative or modifiable intraoperative variables. EVIDENCE ACQUISITION: A systematic review of the English-language literature was conducted using the MEDLINE, Embase, and Web of Science databases from January 2000 to March 2022 according to the PRISMA guidelines (PROSPERO ID: CRD42022303492). Risk of bias was assessed according to the Prediction Model Study Risk of Bias Assessment Tool. EVIDENCE SYNTHESIS: Overall, 21 prediction models from 18 studies were included (nine for PN only; eight for RN only; four for PN or RN). Most studies relied on retrospective patient cohorts and had a high risk of bias and high concern regarding the overall applicability of the proposed model. Patient-, kidney-, surgery-, tumor-, and provider-related factors were included among the predictors in 95%, 86%, 100%, 61%, and 0% of the models, respectively. All but one model included both patient age and preoperative renal function, while only a few took into account patient gender, race, comorbidities, tumor size/complexity, and surgical approach. There was significant heterogeneity in both the model building strategy and the performance metrics reported. Five studies reported external validation of six models, while three assessed their clinical usefulness using decision curve analysis. CONCLUSIONS: Several models are available for predicting postoperative renal function after kidney cancer surgery. Most of these are not ready for routine clinical practice, while a few have been externally validated and might be of value for patients and clinicians. PATIENT SUMMARY: We reviewed the tools available for predicting kidney function after partial or total surgical removal of a kidney for nonmetastatic cancer. Most of the models include patient and kidney characteristics such as age, comorbidities, and preoperative kidney function, and a few also include tumor characteristics and intraoperative variables. Some models have been validated by additional research groups and appear promising for improving counseling for patients with nonmetastatic cancer who are candidates for surgery.

The Future of Medical Devices in Europe Is at Stake: Concerns over the Implementation of the Medical Devices Regulation 2017/745.

In May 2024, all medical devices in Europe will require to comply with the new Medical Device Regulation 2017/745, including those we have been using for years. Currently, there are major delays and problems associated with this new certification. As clinicians, we express our serious concerns regarding whether the system will be ready on time to ensure that all the medical devices that we use will be available for patient care.

Combining PSA and PET features to select candidates for salvage lymph node dissection in recurrent prostate cancer.

Objective: To evaluate the relationship between pre-operative PSA value, 68Ga-prostate-specific-membrane-antigen (PSMA) PET performance and oncologic outcomes after salvage lymph node dissection (sLND) for biochemical recurrent prostate cancer (PCa). Patients and methods: The study included 164 patients diagnosed with ≤2 pelvic lymph-node recurrence(s) of PCa documented on 68Ga-PSMA PET scan and treated with pelvic ± retroperitoneal sLND at 11 high-volume centres between 2012 and 2019. Pathologic findings were correlated to PSA values at time of sLND, categorized in early (<0.5 ng/ml), low (0.5-0.99 ng/ml), moderate (1-1.5 ng/ml) and high (>1.5 ng/ml). Clinical recurrence (CR)-free survival after sLND was calculated using multivariable analyses and plotted over pre-operative PSA value. Results: Median [interquartile range (IQR)] PSA at sLND was 1.1 (0.6, 2.0) ng/ml, and 131 (80%) patients had one positive spot at PET scan. All patients received pelvic sLND, whereas 91 (55%) men received also retroperitoneal dissection. Median (IQR) number of node removed was 15 (6, 28). The rate of positive pathology increased as a function of pre-operative PSA value, with highest rates for patients with pre-operative PSA > 1.5 ng/ml (pelvic-only sLNDs: 84%; pelvic + retroperitoneal sLNDs: 90%). After sLND, PSA ≤ 0.3 ng/ml was detected in 67 (41%) men. On multivariable analyses, pre-operative PSA was associated with PSA response (p < 0.0001). There were 51 CRs after sLND. After adjusting for confounders, we found a significant, non-linear relationship between PSA level at sLND and the 12-month CR-free survival (p < 0.0001), with the highest probability of freedom from CR for patients who received sLND at PSA level ≥1 ng/ml. Conclusions: In case of PET-detected nodal recurrences amenable to sLND, salvage surgery was associated with the highest short-term oncologic outcomes when performed in men with PSA ≥ 1 ng/ml. Awaiting confirmatory data from prospective trials, these findings may help physicians to optimize the timing for 68Ga-PSMA PET in biochemical recurrent PCa.

Cancer literacy - Informing patients and implementing shared decision making.

In order to tailor treatment to their needs, cancer patients are encouraged to be more active and engaged in their care decisions and to be autonomous yet collaborative with their healthcare professionals when it comes to aspects of their treatment in order to get better results. However, this can only happen after providing them with accurate information about cancer and the different treatment alternatives and their potential side effects. However, sharing robust data-based information is often hindered by exposure to misleading information through different media and online platform, where patients might come across unscientifically founded health practices. Increasing health literacy and cancer-specific literacy is essential to fight this negative trend. The idea is that more knowledgeable patients will be able to debunk more easily misinformation they encounter. This is also related to inequalities among cancer patients. Not only levels of cancer literacy within Europe are uneven across and within countries, but there are social groups that, due to specific social determinants, are systematically less informed and skilled regarding cancer care. In this paper an overview of gaps in addressing literacy issues, and the importance of health literacy to empower patients in their journey through treatment is delineated, concluding with some recommendations to improve cancer literacy in Europe.

Predicting short- and long-term renal function following partial and radical nephrectomy.

OBJECTIVES: To externally validate the previously published Mayo clinic model for the prediction of early (<30 days) postoperative renal failure, which relies solely on preoperative estimated glomerular filtration rate (eGFR) and develop a novel model for the prediction of long-term (>30 days) renal function after partial nephrectomy (PN) and radical nephrectomy (RN), including patient factors and nephrometry scores. PATIENTS AND METHODS: Retrospective, single-center cohort study on patients who underwent PN or RN for a unilateral renal tumor between 2003 and 2019 with a preoperative eGFR of at least 15 ml/min/1.73m2. Early postoperative renal failure was defined as eGFR <15 ml/min/1.73 m2 or receipt of dialysis within 30 days. We determined the area under the receiver operating characteristics curve (AUC) to assess the Mayo clinic model's discriminative power. We used hierarchical linear mixed models with backward selection of candidate variables to develop a prediction model for long-term eGFR following PN and RN, separately. Their predictive ability was quantified using the marginal and conditional R2GLMM and an internal validation. RESULTS: We included 421 patients (7,548 eGFR observations) who underwent PN and 271 patients (6,530 eGFR observations) who underwent RN. The Mayo clinic model for prediction of early postoperative renal failure following PN and RN showed an AUC of 0.816 (95% CI 0.718-0.920) and 0.825 (95% CI 0.688-0.962), respectively. In multivariable models, long-term eGFR following PN was associated with age, diabetes, the presence of a solitary kidney, tumor diameter and preoperative eGFR, while long-term eGFR following RN was associated with age, body mass index, RENAL nephrometry score and preoperative eGFR. Marginal and conditional R2GLMM were 0.591 and 0.855 for the PN model, and 0.363 and 0.849 for the RN model, respectively. CONCLUSIONS: The Mayo clinic model for short-term renal failure prediction showed good accuracy on external validation. Our long-term eGFR prediction models depend mostly on host factors as opposed to tumor complexity and can aid in decision-making when considering PN vs. RN.