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4.
Urol Int ; 2024 Feb 07.
Article in English | MEDLINE | ID: mdl-38325350

ABSTRACT

Purpose To investigate non-adherence rates to adjuvant radiotherapy (aRT) after radical prostatectomy (RP) and to obtain patient reported reasons for rejecting aRT despite recommendation by a multidisciplinary team discussion (MTD). Methods In a retrospective monocentric analysis, we identified 1197 prostate cancer patients who underwent RP between 2014-2022 at our institution, of which 735 received a postoperative MTD recommendation. Patients with a recommendation for aRT underwent a structured phone interview with predefined standardised qualitative and quantitative questions and were stratified into "adherent" (aRT performed) and "non-adherent" groups (aRT not performed). Results Of 55 patients receiving a recommendation for aRT (7.5% of all RP patients), 24 (44%) were non-adherent. Baseline tumour characteristics were comparable among the groups. "Fear of radiation damage" was the most common reason for rejection, followed by "lack of information", "feeling that the treating physician does not support the recommendation" and "the impression that aRT is not associated with improved oncological outcome". Salvage radiotherapy (sRT) was performed in 25% of non-adherent patients. Conclusion High rates of non-adherence to aRT after RP were observed, and reasons for this phenomenon are most likely multifactorial. Multidisciplinary and individualized patient counselling might be a key for increasing adherence rates.

5.
World J Urol ; 42(1): 59, 2024 Jan 27.
Article in English | MEDLINE | ID: mdl-38279975

ABSTRACT

PURPOSE: To access the current scenario of robotic-assisted radical prostatectomy training in multiple centers worldwide. METHODS: We created a multiple-choice questionnaire assessing all details of robotic-assisted radical prostatectomy training with 41 questions divided into three different categories (responder demography, surgical steps, and responder experience). The questionnaire was created and disseminated using the "Google Docs" platform. All responders had an individual invitation by direct message or Email. We selected urologists who had recently finished a postgraduation urologic robotic surgery training (fellowship) in the last five years. We sent 624 invitations to urologists from 138 centers, from January 10th to April 10th, 2022. The answers were reported as percentages and illustrated in pie charts. RESULTS: The response rate was 58% among all centers invited (138/81), 20% among all individual invitations (122/624 answers). Globally, we gathered responses from 23 countries. Most surgeons were older than 34 years, 71% trained in an academic center, and 64% performed less than ten full RARP cases. Transperitoneal is the most common access, and 63% routinely opens the endopelvic fascia. Almost 90% perform the Rocco's stitch, and 94% perform the anastomosis with barbed sutures. Finally, only 31% of surgeons assisted more than 100 cases before moving to the console, and most surgeons (63.9%) performed less than ten full RARP cases during their training. CONCLUSION: By assessing the robotic-assisted radical prostatectomy training status in 23 countries and 81 centers worldwide, we assessed the trainees' demography, step-by-step surgical technique, training perspectives, and impressions of surgeons who trained in the last five years. This data is crucial for a better understanding the trainee's standpoint, addressing potential deficiencies, and implementing improvements needed in the training process. Our study clearly indicates elements of current training modalities that are prone to major improvement.


Subject(s)
Laparoscopy , Robotic Surgical Procedures , Robotics , Male , Humans , Robotic Surgical Procedures/methods , Prostatectomy/methods , Prostate , Laparoscopy/methods
6.
Int. braz. j. urol ; 49(6): 677-687, Nov.-Dec. 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1550288

ABSTRACT

ABSTRACT Purpose: Salvage robotic-assisted radical prostatectomy (S-RARP) has gained prominence in recent years for treating patients with cancer recurrence following non-surgical treatments of Prostate Cancer. We conducted a systematic literature review to evaluate the role and outcomes of S-RARP over the past decade. Materials and Methods: A systematic review was conducted, encompassing articles published between January 1st, 2013, and June 1st, 2023, on S-RARP outcomes. Articles were screened according to PRISMA guidelines, resulting in 33 selected studies. Data were extracted, including patient demographics, operative times, complications, functional outcomes, and oncological outcomes. Results: Among 1,630 patients from 33 studies, radiotherapy was the most common primary treatment (42%). Operative times ranged from 110 to 303 minutes, with estimated blood loss between 50 to 745 mL. Intraoperative complications occurred in 0 to 9% of cases, while postoperative complications ranged from 0 to 90% (Clavien 1-5). Continence rates varied (from 0 to 100%), and potency rates ranged from 0 to 66.7%. Positive surgical margins were reported up to 65.6%, and biochemical recurrence ranged from 0 to 57%. Conclusion: Salvage robotic-assisted radical prostatectomy in patients with cancer recurrence after previous prostate cancer treatment is safe and feasible. The literature is based on retrospective studies with inherent limitations describing low rates of intraoperative complications and small blood loss. However, potency and continence rates are largely reduced compared to the primary RARP series, despite the type of the primary treatment. Better-designed studies to assess the long-term outcomes and individually specify each primary therapy impact on the salvage treatment are still needed. Future articles should be more specific and provide more details regarding the previous therapies and S-RARP surgical techniques.

7.
Int Braz J Urol ; 49(6): 677-687, 2023.
Article in English | MEDLINE | ID: mdl-37903005

ABSTRACT

PURPOSE: Salvage robotic-assisted radical prostatectomy (S-RARP) has gained prominence in recent years for treating patients with cancer recurrence following non-surgical treatments of Prostate Cancer. We conducted a systematic literature review to evaluate the role and outcomes of S-RARP over the past decade. MATERIAL AND METHODS: A systematic review was conducted, encompassing articles published between January 1st, 2013, and June 1st, 2023, on S-RARP outcomes. Articles were screened according to PRISMA guidelines, resulting in 33 selected studies. Data were extracted, including patient demographics, operative times, complications, functional outcomes, and oncological outcomes. RESULTS: Among 1,630 patients from 33 studies, radiotherapy was the most common primary treatment (42%). Operative times ranged from 110 to 303 minutes, with estimated blood loss between 50 to 745 mL. Intraoperative complications occurred in 0 to 9% of cases, while postoperative complications ranged from 0 to 90% (Clavien 1-5). Continence rates varied (from 0 to 100%), and potency rates ranged from 0 to 66.7%. Positive surgical margins were reported up to 65.6%, and biochemical recurrence ranged from 0 to 57%. CONCLUSION: Salvage robotic-assisted radical prostatectomy in patients with cancer recurrence after previous prostate cancer treatment is safe and feasible. The literature is based on retrospective studies with inherent limitations describing low rates of intraoperative complications and small blood loss. However, potency and continence rates are largely reduced compared to the primary RARP series, despite the type of the primary treatment. Better-designed studies to assess the long-term outcomes and individually specify each primary therapy impact on the salvage treatment are still needed. Future articles should be more specific and provide more details regarding the previous therapies and S-RARP surgical techniques.


Subject(s)
Prostatic Neoplasms , Robotic Surgical Procedures , Male , Humans , Robotic Surgical Procedures/methods , Retrospective Studies , Treatment Outcome , Neoplasm Recurrence, Local/surgery , Prostatectomy/methods , Intraoperative Complications/etiology
8.
Urol Int ; 107(10-12): 977-982, 2023.
Article in English | MEDLINE | ID: mdl-37879305

ABSTRACT

INTRODUCTION: Solitary fibrous tumors (SFTs) of the prostate are extremely rare. We report on a 60-year-old man who was diagnosed with prostatic SFT through transurethral resection (TUR) of the prostate, and we provide a narrative literature review to put the case into perspective. We looked into multiple databases for articles published before June 2022. CASE REPORT: A 60-year-old man without comorbidities presented with acute urinary retention and significant macrohematuria. Due to recurrent bladder tamponades and relevant blood loss despite irrigation, an emergency endoscopic transurethral evaluation was initiated. Intraoperatively, diffuse venous hemorrhage from prostatic vessels around the bladder neck was detected, as well as significant hemorrhage from a grossly enlarged and tumor-suspicious prostate middle lobe. Within the framework of extensive bipolar coagulation, parts of the suspicious middle lobe were removed via TUR. The final histopathology report showed incompletely resected SFT of the prostate. Due to the extremely rare SFT diagnosis, the case was discussed in an interdisciplinary tumor board and further diagnostic workup, including thoracoabdominal computed tomography and magnetic resonance imaging of the pelvis, was performed, which revealed no secondary tumors or signs of metastasis. According to the tumor board recommendation, robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing was performed, supported by intraoperative frozen section. The final histopathology confirmed the SFT that had developed from the transition zone. The SFT was resected with negative frozen section result and negative surgical margins (R0). No intra- and perioperative complications occurred, and in the short-term follow-up, the patient presented in excellent general status with full continence. From 1997 to June 2022, we identified a total of 12 publications reporting on treatment for prostatic SFT (11 case reports and 2 patient series), with none performing bilateral nerve sparing, frozen section, or robot-assisted radical prostatectomy. No common survival endpoints were accessible. CONCLUSION: This case demonstrates the exceedingly rare case of SFT of the prostate, which has been described in the literature in only 23 men worldwide. Here, we were the first to demonstrate the feasibility of bilateral nerve-sparing RARP supported by frozen section. A systematic review was not possible due to the lack of common endpoints.


Subject(s)
Prostatic Neoplasms , Robotic Surgical Procedures , Robotics , Solitary Fibrous Tumors , Male , Humans , Middle Aged , Prostate/surgery , Prostate/pathology , Frozen Sections , Prostatectomy/methods , Robotic Surgical Procedures/methods , Prostatic Neoplasms/surgery , Prostatic Neoplasms/pathology , Pelvis/pathology , Hemorrhage/surgery
10.
World J Surg Oncol ; 21(1): 189, 2023 Jun 22.
Article in English | MEDLINE | ID: mdl-37349748

ABSTRACT

BACKGROUND: Partial nephrectomy (PN) is the gold standard surgical treatment for resectable renal cell carcinoma (RCC) tumors. However, the decision whether a robotic (RAPN) or open PN (OPN) approach is chosen is often based on the surgeon's individual experience and preference. To overcome the inherent selection bias when comparing peri- and postoperative outcomes of RAPN vs. OPN, a strict statistical methodology is needed. MATERIALS AND METHODS: We relied on an institutional tertiary-care database to identify RCC patients treated with RAPN and OPN between January 2003 and January 2021. Study endpoints were estimated blood loss (EBL), length of stay (LOS), rate of intraoperative and postoperative complications, and trifecta. In the first step of analyses, descriptive statistics and multivariable regression models (MVA) were applied. In the second step of analyses, to validate initial findings, MVA were applied after 2:1 propensity-score matching (PSM). RESULTS: Of 615 RCC patients, 481 (78%) underwent OPN vs 134 (22%) RAPN. RAPN patients were younger and presented with a smaller tumor diameter and lower RENAL-Score sum, respectively. Median EBL was comparable, whereas LOS was shorter in RAPN vs. OPN. Both intraoperative (27 vs 6%) and Clavien-Dindo > 2 complications (11 vs 3%) were higher in OPN (both < 0.05), whereas achievement of trifecta was higher in RAPN (65 vs 54%; p = 0.028). In MVA, RAPN was a significant predictor for shorter LOS, lower rates of intraoperative and postoperative complications as well as higher trifecta rates. After 2:1 PSM with subsequent MVA, RAPN remained a statistical and clinical predictor for lower rates of intraoperative and postoperative complications and higher rates of trifecta achievement but not LOS. CONCLUSIONS: Differences in baseline and outcome characteristics exist between RAPN vs. OPN, probably due to selection bias. However, after applying two sets of statistical analyses, RAPN seems to be associated with more favorable outcomes regarding complications and trifecta rates.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Robotic Surgical Procedures , Humans , Carcinoma, Renal Cell/surgery , Carcinoma, Renal Cell/pathology , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Kidney Neoplasms/surgery , Kidney Neoplasms/pathology , Nephrectomy/adverse effects , Nephrectomy/methods , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Treatment Outcome , Retrospective Studies
11.
Diagnostics (Basel) ; 13(9)2023 May 03.
Article in English | MEDLINE | ID: mdl-37175005

ABSTRACT

We aimed to externally validate the SEER-based nomogram used to predict downgrading in biopsied high-risk prostate cancer patients treated with radical prostatectomy (RP) in a contemporary European tertiary-care-hospital cohort. We relied on an institutional tertiary-care database to identify biopsied high-risk prostate cancer patients in the National Comprehensive Cancer Network (NCCN) who underwent RP between January 2014 and December 2022. The model's downgrading performance was evaluated using accuracy and calibration. The net benefit of the nomogram was tested with decision-curve analyses. Overall, 241 biopsied high-risk prostate cancer patients were identified. In total, 51% were downgraded at RP. Moreover, of the 99 patients with a biopsy Gleason pattern of 5, 43% were significantly downgraded to RP Gleason pattern ≤ 4 + 4. The nomogram predicted the downgrading with 72% accuracy. A high level of agreement between the predicted and observed downgrading rates was observed. In the prediction of significant downgrading from a biopsy Gleason pattern of 5 to a RP Gleason pattern ≤ 4 + 4, the accuracy was 71%. Deviations from the ideal predictions were noted for predicted probabilities between 30% and 50%, where the nomogram overestimated the observed rate of significant downgrading. This external validation of the SEER-based nomogram confirmed its ability to predict the downgrading of biopsy high-risk prostate cancer patients and its accurate use for patient counseling in high-volume RP centers.

12.
J Urol ; 210(1): 126, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37052481
14.
J Clin Med ; 12(5)2023 Feb 23.
Article in English | MEDLINE | ID: mdl-36902562

ABSTRACT

BACKGROUND: Female sex in patients treated by radical cystectomy (RC) is associated with more advanced stage and worse survival. However, studies supporting these findings mostly or exclusively relied on urothelial carcinoma of the urinary bladder (UCUB) and did not address non-urothelial variant-histology bladder cancer (VH BCa). We hypothesized that female sex is associated with a more advanced stage and worse survival in VH BCa, similarly to that of UCUB. MATERIALS AND METHODS: Within the SEER database (2004-2016), we identified patients aged ≥18 years, with histologically confirmed VH BCa, and treated with comprehensive RC. Logistic regression addressing the non-organ-confined (NOC) stage, as well as cumulative incidence plots and competing risks regression addressing CSM for females vs. males, were fitted. All analyses were repeated in stage-specific and VH-specific subgroups. RESULTS: Overall, 1623 VH BCa patients treated with RC were identified. Of those, 38% were female. Adenocarcinoma (n = 331, 33%), neuroendocrine tumor (n = 304, 18%), and other VH (n = 317, 37%) were less frequent in females but not squamous cell carcinoma (n = 671, 51%). Across all VH subgroups, female patients had higher NOC rates than males did (68 vs. 58%, p < 0.001), and female sex was an independent predictor of NOC VH BCa (OR = 1.55, p = 0.0001). Overall, five-year cancer-specific mortality (CSM) were 43% for females vs. 34% for males (HR = 1.25, p = 0.02). CONCLUSION: In VH BC patients treated with comprehensive RC, female sex is associated with a more advanced stage. Independently of stage, female sex also predisposes to higher CSM.

15.
Urol Int ; 107(1): 15-22, 2023.
Article in English | MEDLINE | ID: mdl-35882213

ABSTRACT

INTRODUCTION: The aim of the study was to examine cancer-specific mortality (CSM) of unconventional urethral cancers. METHODS: Within the SEER (2004-2016) database, we analyzed CSM of 165 patients with unconventional urethral-cancer histology. Kaplan-Meier plots were used to test the effect of unconventional histologies in urethral cancer on CSM. RESULTS: Of 165 eligible patients, the Mullerian type accounted for 55 (33.3%) versus melanocytic (26.7%) versus neuroendocrine 25 (15.2%) versus lymphoma 22 (13.3%) versus mesenchymal/sarcoma 15 (9.1%) versus spindle cell 4 (2.1%) patients. Median age at diagnosis was 81 years in spindle cell, 75 in melanocytic, 74 in neuroendocrine and mesenchymal/sarcoma, 67 in lymphoma, and 62 years Mullerian type (p < 0.001). Of all, 116 (70.3%) were female. The Mullerian type exhibited the highest female ratio (96.4%) versus the lowest female ratio in neuroendocrine (24.0%). The Mullerian type was most frequent in African-American females. In Caucasian females, the melanocytic type was most frequent (49.1%). In African-American (38.9%) and Caucasian males (33.3%), neuroendocrine histology was most frequent. Three-year CSM was, respectively, 27.5%, 23.1% 22.3%, 20.5%, and 16.1% for melanocytic, mesenchymal/sarcoma, Mullerian type, neuroendocrine, and lymphoma histology. Median cancer-specific survival was 106 versus 10 months for combined nonmetastatic versus metastatic nonconventional histologies. CONCLUSION: Important age, sex, racial/ethnic group distribution, and survival differences exist between each unconventional urethral-cancer histological subtypes.


Subject(s)
Sarcoma , Urethral Neoplasms , Male , Humans , Female , SEER Program , Sarcoma/pathology
16.
J Racial Ethn Health Disparities ; 10(2): 708-717, 2023 04.
Article in English | MEDLINE | ID: mdl-35182370

ABSTRACT

PURPOSE: To test the effect of race/ethnicity on Social Security Administration (SSA) life tables' life expectancy (LE) predictions in localized prostate cancer (PCa) patients treated with either radical prostatectomy (RP) or external beam radiotherapy (EBRT). We hypothesized that LE will be affected by race/ethnicity. PATIENTS AND METHODS: We relied on the 2004-2006 Surveillance, Epidemiology, and End Results database to identify D'Amico intermediate- and high-risk PCa patients treated with either RP or EBRT. SSA life tables were used to compute 10-year LE predictions and were compared to OS. Stratification was performed according to treatment type (RP/EBRT) and race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic/Latino, and Asian). RESULTS: Of 55,383 assessable patients, 40,490 were non-Hispanic White (RP 49.3% vs. EBRT 50.7%), 7194 non-Hispanic Black (RP 41.3% vs. EBRT 50.7%), 4716 Hispanic/Latino (RP 51.0% vs. EBRT 49.0%) and 2983 were Asian (RP 41.6% vs. EBRT 58.4%). In both RP and EBRT patients, OS exceeded life tables' LE predictions, except for non-Hispanic Blacks. However, in RP patients, the magnitude of the difference was greater than in EBRT. Moreover, in RP patients, OS of non-Hispanic Blacks virtually perfectly followed predicted LE. Conversely, in EBRT patients, the OS of non-Hispanic Black patients was worse than predicted LE. CONCLUSIONS: When comparing SEER-derived observed OS with SSA life table-derived predicted life expectancy, we recorded a survival disadvantage in non-Hispanic Black RP and EBRT patients, which was not the case in the three other races/ethnicities (non-Hispanic Whites, Hispanic/Latinos, and Asians). This discrepancy should ideally be confirmed within different registries, countries, and tumor entities. Furthermore, the source of these discrepant survival outcomes should be investigated and addressed by health care politics.


Subject(s)
Prostatic Neoplasms , United States Social Security Administration , Male , United States/epidemiology , Humans , Life Tables , Ethnicity , Prostatic Neoplasms/therapy , Prostatic Neoplasms/pathology , Life Expectancy
17.
World J Urol ; 41(4): 921-928, 2023 Apr.
Article in English | MEDLINE | ID: mdl-35226140

ABSTRACT

PURPOSE: Prostate cancer (PCa) screening, which relies on prostate-specific antigen (PSA) testing, is a contentious topic that received negative attention due to the low sensitivity and specificity of PSA to detect clinically significant PCa. In this context, due to the higher sensitivity and specificity of magnetic resonance imaging (MRI), several trials investigate the feasibility of "MRI-only" screening approaches, and question if PSA testing may be replaced within prostate cancer screening programs. METHODS: This narrative review discusses the current literature and the outlook on the potential of MRI-based PCa screening. RESULTS: Several prospective randomized population-based trials are ongoing. Preliminary study results appear to favor the "MRI-only" approach. However, MRI-based PCa screening programs face a variety of obstacles that have yet to be fully addressed. These include the increased cost of MRI, lack of broad availability, differences in MRI acquisition and interpretation protocols, and lack of long-term impact on cancer-specific mortality. Partly, these issues are being addressed by shorter and simpler MRI approaches (5-20 min bi-parametric MRI), novel quality indicators (PI-QUAL) and the implementation of radiomics (deep learning, machine learning). CONCLUSION: Although promising preliminary results were reported, MRI-based PCa screening still lack long-term data on crucial endpoints such as the impact of MRI screening on mortality. Furthermore, the issues of availability, cost-effectiveness, and differences in MRI acquisition and interpretation still need to be addressed.


Subject(s)
Prostatic Neoplasms , Male , Humans , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/pathology , Prostate-Specific Antigen , Early Detection of Cancer/methods , Prospective Studies , Magnetic Resonance Imaging/methods
18.
Front Oncol ; 12: 990851, 2022.
Article in English | MEDLINE | ID: mdl-36561531

ABSTRACT

Background: We tested whether a model identifying prostate cancer (PCa) patients at risk of pT3-4/pN1 can be developed for use during COVID19 pandemic, in order to guarantee appropriate treatment to patients harboring advanced disease patients without compromising sustainability of care delivery. Methods: Within the Surveillance, Epidemiology and End Results database 2010-2016, we identified 27,529 patients with localized PCa and treated with radical prostatectomy. A multivariable logistic regression model predicting presence of pT3-4/pN1 disease was fitted within a development cohort (n=13,977, 50.8%). Subsequently, external validation (n=13,552, 49.2%) and head-to-head comparison with NCCN risk group stratification was performed. Results: In model development, age, PSA, biopsy Gleason Grade Group (GGG) and percentage of positive biopsy cores were independent predictors of pT3-4/pN1 stage. In external validation, prediction of pT3-4/pN1 with novel nomogram was 74% accurate versus 68% for NCCN risk group stratification. Nomogram achieved better calibration and showed net-benefit over NCCN risk group stratification in decision curve analyses. The use of nomogram cut-off of 49% resulted in pT3-4/pN1 rate of 65%, instead of the average 35%. Conclusion: The newly developed, externally validated nomogram predicts presence of pT3-4/pN1 better than NCCN risk group stratification and allows to focus radical prostatectomy treatment on individuals at highest risk of pT3-4/pN1.

19.
Cent European J Urol ; 75(3): 240-247, 2022.
Article in English | MEDLINE | ID: mdl-36381153

ABSTRACT

Introduction: Non-urothelial variant histology (VH), non-muscle invasive bladder cancer (NMIBC) has received little attention in contemporary urologic literature. Specifically, the effect of female sex on stage at presentation, as well as on cancer-specific mortality (CSM) have not been previously examined in VH NMIBC. Our aim was to test the effect of female sex on stage at presentation and CSM in VH NMIBC. Material and methods: Within the Surveillance, Epidemiology, and End Results (SEER) database (2004-2016), we identified patients aged ≥18 years, with histologically confirmed VH NMIBC. Logistic regression models addressed T1 stage at diagnosis after multivariable adjustments for tumor grade, age and race/ethnicity. Before Kaplan-Meier plots and Cox regression analyses, propensity score matched adjusting for histological variants, T-stage, tumor grade, age and race/ethnicity was performed. Results: Overall, 2,205 VH NMIBC patients were identified. Of those, 28% (n = 607) were female. Females were older (77 vs 74 years, p <0.001) and more frequently harbored T1 stage (55 vs 45%, p <0.001). Female sex independently predicted T1 stage (odds ratio [OR] = 1.66, 95% Confidence Interval [CI] = 1.35-2.03, p <0.001). Female sex also exhibited higher CSM, after matching for all assessable variables, including stage (hazard ratio [HR] = 1.91, 95% CI = 1.45-2.54, p <0.001). Conclusions: In VH NMIBC, female sex is an indicator of higher rate of T1 stage and, fully independently of stage, female sex also results in higher CSM.

20.
Front Oncol ; 12: 1019057, 2022.
Article in English | MEDLINE | ID: mdl-36300101

ABSTRACT

Background: Only one previously published study by Nocera et al. addressed the risk of upstaging to ≥pT3 in cT1 clear cell renal cell carcinoma (ccRCC) by using characteristics of the R.E.N.A.L and PADUA score (age, tumor size, rim location, exophytic rate, polar involvement) developing an accurate nomogram. However, this nomogram has never been externally validated yet. Material and methods: The study cohort consisted of 288 patients with cT1a-b ccRCC, diagnosed between 2008-2021 at the University Hospital Frankfurt, Germany. Analyses addressed clinical, tumor and radiographic characteristics. The external validation of the nomogram relied on accuracy calculations derived from the area under the curve of the receiver operator characteristic analysis. Results: Overall, 11.8% (n=34) patients harbored ≥pT3 ccRCC. Median radiographic tumor size (3.6 vs. 5.3cm), R.E.N.A.L. (8 vs. 9 points) and PADUA score (9 vs. 11 points), as well as proportions of renal sinus involvement (82.4% vs. 51.6%), renal hilus involvement (44.1 vs. 13.0%), and medial rim location significantly differed between the pT1-2 and ≥pT3 group (all p ≤ 0.01). In subgroup analyses of small renal mass ccRCC patients (<4cm, cT1a), only 3.8% (n=6) patients had ≥pT3 pathology. Upstaged patients were significantly older and more frequently had endophytic tumor than pT1-2 counterparts (p<0.05). The external validation of the Nocera nomogram showed a good accuracy of 76.6%. Using the suggested cut-off of 21%, 26.5% of patients exhibited ≥pT3 ccRCC. Conversely, within patients below cut-off, 5.9% patients exhibited ≥pT3 ccRCC. Conclusion: We reported the first external validation of the nomogram addressing the risk of ≥pT3 in cT1 ccRCC patients, demonstrating a good accuracy, with a low false-negative rate. Therefore, the nomogram can accurately be used for patients' counselling and treatment decision making.

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