Background and objective: Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is increasingly used for primary staging in prostate cancer. Owing to accurate detection of small metastases on PSMA-PET/CT, patient selection for robot-assisted radical prostatectomy (RARP) has likely changed. This study analyzes oncological outcomes in patients undergoing RARP and extended pelvic lymph node dissection (ePLND) after PSMA-PET/CT staging, compared with those without PSMA-PET/CT. Methods: Patients who underwent staging with PSMA-PET/CT before RARP and ePLND ("PSMA cohort"; 2016-2021) were compared with patients staged without PSMA-PET/ CT ("historical cohort"; 2013-2016). Propensity score matching using preoperative variables was performed to limit confounding. As primary outcome measure of biochemical recurrence (BCR)-free survival (BFS) was analyzed, with BCR defined as a prostate specific antigen value of >= 0.2 ng/ml or start of additional therapy after surgery. Key findings and limitations: After matching, 880 patients were included (440 in each cohort). The median follow-up was 35 mo (interquartile range 21-60) for the entire cohort. In the PSMA cohort, 126/440 patients (29%) experienced BCR versus 205/440 (47%) in the historical cohort (log-rank test p = 0.032). A multivariable Cox regression analysis showed an independent effect of preoperative PSMA-PET/CT staging on BFS (hazard ratio 0.70, 95% confidence interval 0.55-0.89, p = 0.0030). Conclusions and clinical implications: Patients who underwent staging with PSMA-PET/ CT had longer biochemical progression-free survival after RARP and ePLND than those without PSMA-PET/CT. This suggests that PSMA-PET/CT staging alters patient selection for RARP and ePLND, and is associated with improved early oncological outcomes for patients who still undergo surgery. Patient summary: Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) at the diagnosis of prostate cancer leads to better visualization of metastases and therefore better selection of prostate cancer patients for surgery. Patients who underwent a PSMA-PET/CT scan at the time of diagnosis showed improved oncological outcomes, including longer progression-free survival and less prostate-specific antigen persistence after surgery. (c) 2024 Published by Elsevier B.V. on behalf of European Association of Urology.

Background/Objectives: In men with biochemical recurrence (BCR) after a radical prostatectomy (RP), salvage radiotherapy (SRT) is commonly recommended when imaging shows no metastases. The optimal management for patients with negative prostate-specific membrane antigen (PSMA) PET/CT findings at BCR remains uncertain. This study evaluated outcomes of patients with BCR and negative PSMA PET/CT to identify who may be safely observed and who may benefit from early SRT. Methods: This retrospective multicentre cohort study included 89 patients with BCR and negative PSMA PET/CT findings after a RP (2015–2022) who were managed with observation. The exclusion criteria were PSA levels ≥ 0.8 ng/mL at baseline, prior SRT, or prior or ongoing hormonal therapy. Minimum follow-up was 3 years. Biochemical progression (PSA rise > 0.2 ng/mL above baseline or initiation of additional treatment) and radiological progression (local or metastatic disease on follow-up PSMA PET/CT) were assessed. Patients were stratified by EAU BCR-risk classification. Multivariable Cox regression included age, biochemical persistence (BCP) after a RP, pathological tumour stage (pT), pathological ISUP grade group (pISUP), node status (pN), margin status (R), and PSA doubling time (PSAdt). Results: The median age was 66 years (IQR 60–69) and the median PSA measurement at BCR was 0.2 ng/mL (IQR 0.2–0.3). A total of 27/89 (30%) patients were EAU BCR low-risk and 62/89 (70%) were high-risk. At three years, biochemical progression occurred in 14/27 (52%) low-risk vs. 51/62 (83%) high-risk patients, with time to progression being 21 vs. 12 months (p = 0.01). A pISUP grade group ≥ 4 (HR 2.04 [95%-CI 1.11–3.74]; p = 0.022) and a PSAdt < 20 months (HR 5.72 [95%-CI 2.41–13,56]; p < 0.01) independently predicted biochemical progression. Radiological progression occurred in 43/68 (66%) rescanned patients, with 32/43 (74%) showing disease outside the prostatic fossa. Conclusions: Nearly half of patients with BCR and negative PSMA PET/CT findings who were classified as EAU BCR low-risk remained progression-free at three years. These results support a risk-adapted approach, indicating that SRT may be deferred in selected low-risk patients.

Verschillende risicoclassificatiesystemen (RCS) worden wereldwijd gebruikt om patiënten met nieuw gediagnosticeerde prostaatkanker in prognostische groepen in te delen. Deze studie onderzocht de voorspellende waarde van risicogroepen (laag, intermediair en hoog risico) binnen vier RCS (EAU, NCCN, CPG en CAPRA) voor het detecteren van metastasen op PSMA-PET/CT. Metastasen werden gevonden bij 35

BackgroundVarious risk classification systems (RCSs) are used globally to stratify newly diagnosed patients with prostate cancer (PCa) into prognostic groups.ObjectiveTo compare the predictive value of different prognostic subgroups (low-, intermediate-, and high-risk disease) within the RCSs for detecting metastatic disease on prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) for primary staging, and to assess whether further subdivision of subgroups would be beneficial.Design, setting, and participantsPatients with newly diagnosed PCa, in whom PSMA-PET/CT was performed between 2017 and 2022, were studied retrospectively. Patients were stratified into risk groups based on four RCSs: European Association of Urology, National Comprehensive Cancer Network (NCCN), Cambridge Prognostic Group (CPG), and Cancer of the Prostate Risk Assessment.Outcome measurements and statistical analysisThe prevalence of metastatic disease on PSMA-PET/CT was compared among the subgroups within the four RCSs.Results and limitationsIn total, 2630 men with newly diagnosed PCa were studied. Any metastatic disease was observed in 35% (931/2630) of patients. Among patients classified as having intermediate- and high-risk disease, the prevalence of metastases ranged from approximately 12% to 46%. Two RCSs further subdivided these groups. According to the NCCN, metastatic disease was observed in 5.8%, 13%, 22%, and 62% for favorable intermediate-, unfavorable intermediate-, high-, and very-high-risk PCa, respectively. Regarding the CPG, these values were 6.9%, 13%, 21%, and 60% for the corresponding risk groups.ConclusionsThis study underlines the importance of nuanced risk stratification, recommending the further subdivision of intermediate- and high-risk disease given the notable variation in the prevalence of metastatic disease. PSMA-PET/CT for primary staging should be reserved for patients with unfavorable intermediate- or higher-risk disease.Patient summaryThe use of various risk classification systems in patients with prostate cancer helps identify those at a higher risk of having metastatic disease on prostate-specific membrane antigen positron emission tomography/computed tomography for primary staging.

In Chapter 2 we investigated the role of PSMA-PET detecting pelvic lymph node metastatic disease, and assessed whether we could select patients who may be candidates to withhold an extended pelvic lymph node dissection (ePLND). We found patients with intermediate risk PCa and a radiological T-stage <rT3 on mpMRI are potential candidates to withhold ePLND in the presence of a “negative for lymph node metastases” PSMA-PET scan. In Chapter 3, we aimed to identify predictors of early oncological outcomes in patients undergoing RARP and ePLND for localized prostate cancer. We observed that higher initial PSA values, biopsy Grade Group ≥4, ≥rT3 disease on MRI and lymph node metastases on PSMA-PET (molecular imaging (mi)N1) were significant predictors of early biochemical progression after RARP. In Chapter 4, we found that, in patients with pN1-disease, those with miN1 disease on staging PSMA-PET have an impaired prognosis compared to patients with a negative for metastases staging PSMA-PET. Apparently, miN1-disease is a significant predictor for biochemical progression after surgery, independent of surgical pathology results. Besides, the majority of patients with pN1-disease had biochemical progression within 2 years after surgery. In Chapter 5, we concluded that the addition of PSMA-PET to the previously developed nomograms for predicting pN1-disease showed substantially improved predictive performance, which suggests that PSMA-PET is likely a future candidate for a modern predictive nomogram. Consequently, in Chapter 6, the Amsterdam-Brisbane-Sydney nomogram was developed and validated in an external international validation cohort. We found that the validated Amsterdam-Brisbane-Sydney-nomogram performs superior to the Briganti-2017 and MSKCC-nomogram, and similar to the Briganti-2019 nomogram. Furthermore, it is applicable in all patients with newly diagnosed unfavorable intermediate and high risk PCa. In Chapter 7, we investigated the role of PSMA-PET in patients with biochemical persistence (i.e., persistently measurable PSA) after RARP. In our study, which included a total of 150 patients, we found that a high proportion of patients (59%) had metastatic lesions on PSMA-PET outside the prostatic fossa (i.e., metastatic disease). In Chapter 8, we assessed the role of 18F-DCFPyL PET/CT, a PSMA-tracer, on management decisions in patients with BCR after definitive treatment. We concluded that 18F-DCFPyL PET/CT had a significant impact on the intended management of patients with biochemically recurrent hormone-sensitive prostate cancer. In 40.7% of cases, a preferred treatment change based on the PSMA-PET findings was reported. Chapter 9 focused on the role of PSMA-PET in the evaluation of response of patients who underwent SRT to the prostatic fossa for BCR prostate cancer after RARP. On multivariable analysis, evidence of local recurrent disease on PSMA-PET was significantly associated with developing a treatment response, compared to patients with a negative PSMA-PET. In Chapter 10, we directly compared the oncological outcome following SRT of a patient cohort that underwent PSMA-PET imaging prior to SRT with that of a patient cohort that did not have PSMA-PET imaging before SRT. To compare both cohorts, case-control matching was performed. After case-control matching, 216 patients were matched in both cohorts (108 patients per cohort). In the patient cohort without PSMA-PET/CT prior to SRT, 23 of 108 patients (21%) had biochemical progression of disease at 1 year after SRT, compared with nine (8%) who underwent restaging PSMA-PET/CT prior to SRT (p = 0.007). In Chapter 11 we aimed to develop a novel nomogram predicting the early oncological outcomes of patients undergoing SRT, who were priorly restaged with PSMA-PET imaging. The final nomogram consisted of PSA-value at initiation of SRT, pathological Grade Group, surgical margin status, PSA doubling time, PSMA-PET findings and the presence of BCP after RARP, showing good performance (AUC 0.72 95%CI 0.64-0.79).

Background and objective: Owing to the greater use of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in patients with biochemical recurrence (BCR) of prostate cancer (PCa) after robot-assisted radical prostatectomy (RARP), patient selection for local salvage radiation therapy (sRT) has changed. Our objective was to determine the short-term efficacy of sRT in patients with BCR after RARP, and to develop a novel nomogram predicting BCR-free survival after sRT in a nationwide contemporary cohort of patients who underwent PSMA PET/CT before sRT for BCR of PCa, without evidence of metastatic disease. Methods: All 302 eligible patients undergoing PCa sRT in four reference centers between September 2015 and August 2020 were included. We conducted multivariable logistic regression analysis using a backward elimination procedure to develop a nomogram for predicting biochemical progression of PCa, defined as prostate-specific antigen (PSA) >= 0.2 ng/ml above the post-sRT nadir within 1 yr after sRT. Key findings and limitations: Biochemical progression of disease within 1 yr after sRT was observed for 56/302 (19%) of the study patients. The final predictive model included PSA at sRT initiation, pathological grade group, surgical margin status, PSA doubling time, presence of local recurrence on PSMA PET/CT, and the presence of biochemical persistence (first PSA result >= 0.1 ng/ml) after RARP. The area under the receiver operating characteristic curve for this model was 0.72 (95% confidence interval 0.64-0.79). Using our nomogram, patients with a predicted risk of >20% had a 30.8% chance of developing biochemical progression within 1 yr after sRT. Conclusions: Our novel nomogram may facilitate better patient counseling regarding early oncological outcome after sRT. Patients with high risk of biochemical progression may be candidates for more extensive treatment. Patient summary: We developed a new tool for predicting cancer control outcomes of radiotherapy for patients with recurrence of prostate cancer after surgical removal of their prostate. This tool may help in better counseling of these patients with recurrent cancer regarding their early expected outcome after radiotherapy. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Background: Preoperative assessment of the probability of pelvic lymph-node meta-static disease (pN1) is required to identify patients with prostate cancer (PCa) who are candidates for extended pelvic lymph-node dissection (ePLND).Objective: To develop a novel intuitive prognostic nomogram for predicting pathological lymph-node (pN) status in contemporary patients with primary diagnosed localized PCa, using preoperative clinical and histopathological parameters, magnetic resonance imaging (MRI), and prostate-specific membrane antigen (PSMA) positron emission tomography (PET).Design, setting, and participants: In total, 700 eligible patients who underwent robot -assisted radical prostatectomy and ePLND were included in the model-building cohort. The external validation cohort consisted of 305 surgically treated patients. Logistic regression with backward elimination was used to select variables for the Amsterdam-Brisbane-Sydney nomogram.Outcome measurements and statistical analysis: Performance of the final model was evaluated using the area under the receiver operating characteristic curve (AUC), calibration plots, and decision-curve analyses. Models were subsequently validated in an external population.Results and limitations: The Amsterdam-Brisbane-Sydney nomogram included initial prostate-specific antigen value, MRI T stage, highest biopsy grade group (GG), biopsy technique, percentage of systematic cores with clinically significant PCa (GG >= 2), and lymph-node status on PSMA-PET. The AUC for predicting pN status was 0.81 (95% confidence interval [CI] 0.78-0.85) for the final model. On external validation, the Amsterdam-Brisbane-Sydney nomogram showed superior discriminative ability to the Briganti-2017 and Memorial Sloan Kettering Cancer Center (MSKCC) nomograms (AUC 0.75 [95% CI 0.69-0.81] vs 0.67 [95% CI 0.61-0.74] and 0.65 [95% CI 0.58-0.72], respectively; p < 0.05), and similar discriminative ability to the Briganti-2019 nomogram (AUC 0.78 [95% CI 0.71-0.86] vs 0.80 [95% CI 0.73-0.86]; p = 0.76). The Amsterdam-Brisbane -Sydney nomogram showed excellent calibration on external validation, with an increased net benefit at a threshold probability of >= 4%.Conclusions: The validated Amsterdam-Brisbane-Sydney nomogram performs superior to the Briganti-2017 and MSKCC nomograms, and similar to the Briganti-2019 nomogram. Furthermore, it is applicable in all patients with newly diagnosed unfavorable intermediate-and high-risk PCa.Patient summary: We developed and validated the Amsterdam-Brisbane-Sydney nomogram for the prediction of prostate cancer spread to lymph nodes before surgery. This nomogram performs similar or superior to all presently available nomograms.(c) 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.

Prostate-specific membrane antigen (PSMA) positron emission tomography/ computed tomography (PET/CT) is recognized as the most accurate imaging modality for detection of metastatic high-risk prostate cancer (PCa). Its role in the local staging of disease is yet unclear. We assessed the intra- and interobserver variability, as well as the diagnostic accuracy of the PSMA PET/CT based molecular imaging local tumour stage (miT-stage) for the local tumour stage assessment in a large, multicentre cohort of patients with intermediate and high-risk primary PCa, with the radical prostatectomy specimen (pT-stage) serving as the reference standard. A total of 600 patients who underwent staging PSMA PET/CT before robot-assisted radical prostatectomy was studied. In 579 PSMA positive primary prostate tumours a comparison was made between miT-stage as assessed by four nuclear physicians and the pT-stage according to ISUP protocol. Sensitivity, specificity and diagnostic accuracy were determined. In a representative subset of 100 patients, the intra-and interobserver variability were assessed using Kappa-estimates. The sensitivity and specificity of the PSMA PET/CT based miT-stage were 58

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy IV (PD61)1 May 2024PD61-03 EXTERNAL VALIDATION OF THE AVAILABLE NOMOGRAMS FOR THE IDENTIFICATION OF CANDIDATES FOR a STAGING EXTENDED PELVIC LYMPH NODE DISSECTION AT THE TIME OF RADICAL PROSTATECTOMY IN PROSTATE CANCER PATIENTS PREOPERATIVELY STAGED WITH PSMA PET Francesco Barletta, Simone Scuderi, Lorenzo Bianchi, Daniele Robesti, Pawel Rajwa, Timo F. W. Soeterik, Dennie Meijer, Christopher Darr, Hongqian Guo, Fabio Zattoni, Wolfgang Fendler, Giancarlo Marra, Steven Joniau, Riccardo Schiavina, Agostino Mattei, Cristian Fiori, Francesco Porpiglia, Maria Picchio, Roderick van den Bergh, Shahrok Shariat, Arturo Chiti, Francesco Montorsi, Alberto Briganti, and Giorgio Gandaglia Francesco BarlettaFrancesco Barletta , Simone ScuderiSimone Scuderi , Lorenzo BianchiLorenzo Bianchi , Daniele RobestiDaniele Robesti , Pawel RajwaPawel Rajwa , Timo F. W. SoeterikTimo F. W. Soeterik , Dennie MeijerDennie Meijer , Christopher DarrChristopher Darr , Hongqian GuoHongqian Guo , Fabio ZattoniFabio Zattoni , Wolfgang FendlerWolfgang Fendler , Giancarlo MarraGiancarlo Marra , Steven JoniauSteven Joniau , Riccardo SchiavinaRiccardo Schiavina , Agostino MatteiAgostino Mattei , Cristian FioriCristian Fiori , Francesco PorpigliaFrancesco Porpiglia , Maria PicchioMaria Picchio , Roderick van den BerghRoderick van den Bergh , Shahrok ShariatShahrok Shariat , Arturo ChitiArturo Chiti , Francesco MontorsiFrancesco Montorsi , Alberto BrigantiAlberto Briganti , and Giorgio GandagliaGiorgio Gandaglia View All Author Informationhttps://doi.org/10.1097/01.JU.0001009352.31737.3d.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Available guidelines recommend performing extended pelvic lymph node dissection (ePLND) in radical prostatectomy (RP) prostate cancer (PCa) patients at higher risk of lymph node invasion (LNI) for staging purposes. Novel risk tools aimed at predicting LNI in men staged with PSMA-PET have been developed but not yet included in the guidelines. Here, we aim to externally validate available tools to predict LNI in men with a negative preoperative PSMA-PET (miN0). METHODS: A total of 267 miN0 PCa patients treated with RP and extended pelvic lymph node dissection (ePLND) at 9 referral centres between 2016-2023 were identified. Individual LNI risk was calculated relying on the coefficients of the MSKCC, Amsterdam-Brisbane-Sydney, Briganti 2012-2017-2019 and 2023 nomograms. The extent of over- or underestimation associated with their use was depicted using calibration plots. The discrimination of these models was quantified using the C-index. The net benefit was assessed using decision-curve analysis (DCA). We then assessed the number of LNI missed and the number of ePLND procedures avoided using a 5% threshold for each available tool. RESULTS: A total of 28 (10%) patients harbored LNI at final pathology. Overall, ISUP grade group distribution and MRI stage were as follows: 49 (18%) vs 48 (18%) vs 115 (43%) vs 55 (21%) for 1-2 vs 3 vs 4 vs 5; and 203 (76%) vs 47 (18%) vs 17 (6.4%) for organ-confined vs extracapsular- vs seminal vesicles-extension. The C-index for the MSKCC, Amsterdam-Brisbane-Sydney, Briganti 2012-2017-2019 and 2023 nomograms were 65, 67, 69, 64, 74 and 79%. While the MSKCC, Amsterdam-Brisbane-Sydney, Briganti 2012-2017-2019 nomograms were associated with a risk of overestimation, the Briganti 2023 nomogram exhibited optimal concordance at predicted risk of LNI ≤20%. At DCA, the Briganti 2023 nomogram exhibited higher net-benefit (Figure). Adoption of a 5% cut-off of the Briganti 2023 nomogram would have spared 120 (45%) ePLND with 4 (3%) LNI missed. CONCLUSIONS: The use of the recently proposed Briganti 2023 nomogram in miN0 patients is associated with a substantially higher number of ePLNDs spared with only 3% LNI missed. This model exhibited excellent discrimination, calibration and net benefit compared to available models at external validation. Download PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1280 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Francesco Barletta More articles by this author Simone Scuderi More articles by this author Lorenzo Bianchi More articles by this author Daniele Robesti More articles by this author Pawel Rajwa More articles by this author Timo F. W. Soeterik More articles by this author Dennie Meijer More articles by this author Christopher Darr More articles by this author Hongqian Guo More articles by this author Fabio Zattoni More articles by this author Wolfgang Fendler More articles by this author Giancarlo Marra More articles by this author Steven Joniau More articles by this author Riccardo Schiavina More articles by this author Agostino Mattei More articles by this author Cristian Fiori More articles by this author Francesco Porpiglia More articles by this author Maria Picchio More articles by this author Roderick van den Bergh More articles by this author Shahrok Shariat More articles by this author Arturo Chiti More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Giorgio Gandaglia More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction Radical cystectomy improves survival of patients with muscle invasive and high-risk non-muscle invasive bladder cancer, but is a challenging surgical procedure as patients may experience major complications after surgery. Objectives To assess the incidence of Clavien-Dindo ≥3 complications in patients who underwent radical cystectomy and to assess the association of these complications with pre-operative and peroperative parameters. The secondary aim was to study the association of complications with long-term oncological outcome. Methods A nationwide registry was set up in 19 Dutch hospitals that studied patients with muscle invasive bladder cancer and high-risk non-muscle invasive bladder cancer treated by radical cystectomy. Major complications were classified as complications that were related to uretero-ileal anastomosis, intra-abdominal (e.g. urinoma, bowel leakage) infectious and cardiovascular complications. Multivariable logistic regression analyses were performed to assess the correlation between these groups and perioperative, clinical and pathological factors. Kaplan-Meier survival curves were constructed to analyze the correlation between complications and overall survival. Results The study population consisted of 1,464 patients, of whom 420 (29%) developed severe complications. The most common complications were intra-abdominal (n=328, 60%) and uretero-ileal anastomosis related (n=92, 17%). Male gender (odds ratio 1.6, p=0.007), American Society of Anaesthesiologists score ≥3 (odds ratio 1.6, p=0.003), Charlson Comorbidity Index score ≥5 (odds ratio 2.1, p=0.002) and blood loss >700ml (odds ratio 1.4, p=0.044) were associated with severe complications. In addition, open radical cystectomy was associated with multiple complications (odds ratio 2.6, p=0.001). Furthermore, the overall survival of patients with major complications was worse than those who had no major complications. The median overall survival was 3.8 years versus 6.2 years for patients with and without severe complications (p<0.001). Conclusions In a real-world setting, 29% of patients undergoing radical cystectomy developed severe complications. The risk of severe complications was higher in men, patients with impaired pre-operative condition, and in those who underwent open surgery. Severe complications had a negative impact on overall survival.

Purpose: Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is an emerging staging tool for patients with primary high-risk prostate cancer (PCa). Patients with primary metastatic disease are staged using PSMA-PET/CT imaging, while previously published randomized clinical trials relied on conventional imaging (i.e., bone scintigraphy (BS) results. The aim of this study was to compare the ability of bone metastatic lesion detection and changes in staging for 18F-PSMA-PET/CT versus BS in high-risk PCa patients. Methods: 79 patients with high-risk PCa were prospectively staged using BS and subsequent 18F-PSMA-PET/CT before initial therapy. Patients who presented with a BS showing no metastases represented Group 1, and patients with a BS showing low-volume disease accord-ing to the CHAARTED criteria (<4 bone metastases, no metastases outside vertebral column or pelvis and no visceral metastases) repre-sented Group 2. Metastatic risk group according to CHAARTED and treatment strategies based on both imaging modalities were assessed. Results: A change of CHAARTED risk group was observed in 9/70 (12.8%) of patients in Group 1. In Group 2, a change of risk group was found in 66.7% of patients, due to either upstaging (4/9 patients (44.4%)) and downstaging (2/9 patients (22.2%)). Treatment changes due to use of a different imaging modality occurred in almost 20% of patients. Conclusion: In patients with negative for cancer results on BS, upstaging on 18F-PSMA-PET/CT occurred only infrequently. Moreover, 18F-PSMA-PET/CT resulted in both upstaging and downstaging in a substantial subset of patients with low-volume metastatic disease on BS. Treatment changes occurred in almost 20% of cases depending on imaging results. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Background and objectives: The association between prostate-specific antigen (PSA) level and probability of metastatic disease on prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) has not yet been established in patients with newly diagnosed prostate cancer (PCa). Our objective was to assess the probability of metastatic disease within different PSA ranges using PSMA PET/CT for initial staging of PCa, and to identify both the anatomical distribution and the predictors of metastases on PSMA PET/CT. Methods: In total, 2193 patients with newly diagnosed PCa were retrospectively studied. PSMA PET/CT was performed for staging purposes between January 2017 and May 2022. The proportion of patients with PSMA-avid metastases, stratified by PSA level, was studied. A vast majority of patients in whom at least one high-risk prognostic factor was present underwent PSMA PET/CT. A multivariable logistic regression analysis was performed to identify the predictors of metastases on PSMA PET/CT using clinical, biochemical, radiological, and pathological variables. Key findings and limitations: The median PSA level at PSMA PET/CT was 14.1 ng/ml. Any metastatic disease (miN1-M1a-c) was observed in 34.7% (763/2193) of all patients and distant metastases (miM1a-c) in 25.4% (557/2193) of patients. The presence of any metastatic disease increased with PSA levels, being 15.4% in men with PSA levels <10 ng/ml and 87.5% in men with PSA levels >100 ng/ml. The multivariable logistic regression analysis found significant associations between the presence of any metastatic disease and PSA subgroups, clinical tumor stage ≥T2, grade group >3, and radiological tumor stage ≥T3b. Conclusions and clinical implications: This is the first large epidemiological study in patients with PCa demonstrating the association between PSA subgroups and metastatic disease on modern imaging PSMA PET/CT. Data from this study can be used to counsel patients on the probability of metastatic disease at the time of PSA screening and to provide guidance on existing guidelines. Patient summary: The prostate-specific antigen level could be used to assess the risk of metastases on prostate-specific membrane antigen positron (PSMA) emission tomography/computed tomography (PET/CT). This knowledge is valuable for selecting patients who will benefit most from metastatic screening with PSMA PET/CT.

Background: The currently advised follow-up scheme of PSA testing after robot-assisted radical prostatectomy (RARP) is strict and might pose a burden to our healthcare system. We aimed to optimize the 1-year follow-up scheme for patients who undergo RARP. Methods: All patients with histologically-proven prostate cancer (PCa) who underwent RARP between 2018 and August 2022 in the Prostate Cancer Network in the Netherlands were retrospectively evaluated. We excluded patients who underwent salvage RARP and patients who had <1 year of PSA follow-up. Postoperative PSA values were collected. Biochemical persistence (BCP) was defined as PSA level >0.10 ng/mL at 0–4 months after RARP, whereas biochemical recurrence (BCR) was defined as PSA level >0.2 ng/mL at any time point after RARP. We aimed to identify a group of patients who had a very low risk of BCR at different time points after surgery. Results: Of all 1155 patients, BCP was observed in 151 (13%), of whom 79 (6.8%) had PSA ≥ 0.2 ng/mL. BCR further developed in 51 (4.7%) and 37 (3.4%) patients at 5–8 and 9–12 months after RARP, respectively. In 12 patients, BCR was found at 5–8 months after RARP in the absence of BCP. These patients represented 1.2% (12/1004) of the entire group. In other words, 98.8% (992/1004) of patients who had an unmeasurable PSA level at 0–4 months after RARP also had an unmeasurable PSA level 5–8 months after surgery. Limitations are the retrospective design and incomplete follow-up. Conclusions: Patients with an unmeasurable PSA level at 3–4 months after RARP may not need to be retested until 12 months of follow-up, as almost 100% of patients will not have the biochemically recurrent disease at 5–8 months of follow-up. This will reduce PSA testing substantially at the cost of hardly any missed patients with recurrent disease.

ObjectiveTo assess whether a diagnostic pathway in which prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) is used as a single imaging modality is feasible to guide targeted biopsy and to detect clinically significant prostate cancer (csPCa) in biopsy-naive men at high-risk of disease.Patients and MethodsA total of 60 men with a prostate-specific antigen (PSA) level of 20-50 ng/mL underwent F-18-PSMA(DCFPyL)-PET/CT prior to prostate biopsies in this prospective, non-randomised cohort study. Magnetic resonance imaging (MRI) was not performed. Using a 12-segment mapping model of the prostate, PSMA-guided targeted biopsy was performed along with systematic biopsies. The detection rate of PCa and csPCa was assessed for combined systematic and targeted biopsy, and for targeted biopsy only. csPCa was defined as a prostate biopsy with an International Society of Uropathology (ISUP) Grade Group =2.ResultsLesions suspicious for PCa in the prostate gland were observed on all PSMA-PET/CTs. A total of 27/60 men (45%) already had metastatic disease on staging F-18-PSMA(DCFPyL)-PET/CT. Combined PSMA-guided targeted and systematic biopsies detected PCa in 56/60 (93.3%) patients, with 52 of them (92.9%) having csPCa. PSMA-guided targeted biopsy, if performed as a single biopsy modality, identified PCa in 52/60 men (86.7%) and in 27/27 men (100%) men with metastases.ConclusionsUsing the PSMA-driven single imaging modality pathway in biopsy-naive men at high-risk of PCa, a substantial number of diagnostic MRI scans could be avoided while at the same time obtaining adequate targeting, staging, and detection of csPCa.

SamenvattingEr is onvoldoende bekend over de middellangetermijnoverleving van niet-gemetastaseerd spierinvasieve blaaskanker (SIBC) na open (ORC) versus robotgeassisteerde (RARC) cystectomie, met of zonder neoadjuvante chemotherapie (NAC). Om de vijfjaarsoverleving na beide interventies en de invloed van NAC te onderzoeken, is een retrospectieve studie verricht in 19 Nederlandse ziekenhuizen tussen 2012 en 2015. Van de totaal 1.534 cT1-4N0-1-patiënten ondergingen 1.086 patiënten een ORC en 389 een RARC. De vijfjaarsoverleving was 51% na ORC (95%-BI 47–53) versus 58% na RARC (95%-BI 52–63); de hazard ratio na multivariabele correctie was 1,00 (95%-BI 0,84–1,20). 226 van de 965 cT2-4aN0-patiënten werden behandeld met NAC. Na case-control matching bleek (y)pT0 vaker voor te komen na NAC dan zonder NAC (31 vs. 15%; p < 0,01). De beste vijfjaarsoverleving trad op bij patiënten met ypT0 na NAC, namelijk 89% (95%-BI 81–97). Concluderend laat deze deze studie bij patiënten met SIBC vergelijkbare vijfjaarsoverleving zien na ORC of na RARC. De beste overleving was bij patiënten die waren behandeld met NAC voorafgaand aan cystectomie.

To assess whether a diagnostic pathway in which prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) is used as a single imaging modality is feasible to guide targeted biopsy and to detect clinically significant prostate cancer (csPCa) in biopsy-naïve men at high-risk of disease. A total of 60 men with a prostate-specific antigen (PSA) level of 20–50 ng/mL underwent 18 F-PSMA(DCFPyL)-PET/CT prior to prostate biopsies in this prospective, non-randomised cohort study. Magnetic resonance imaging (MRI) was not performed. Using a 12-segment mapping model of the prostate, PSMA-guided targeted biopsy was performed along with systematic biopsies. The detection rate of PCa and csPCa was assessed for combined systematic and targeted biopsy, and for targeted biopsy only. csPCa was defined as a prostate biopsy with an International Society of Uropathology (ISUP) Grade Group ≥2. Lesions suspicious for PCa in the prostate gland were observed on all PSMA-PET/CTs. A total of 27/60 men (45%) already had metastatic disease on staging 18 F-PSMA(DCFPyL)-PET/CT. Combined PSMA-guided targeted and systematic biopsies detected PCa in 56/60 (93.3%) patients, with 52 of them (92.9%) having csPCa. PSMA-guided targeted biopsy, if performed as a single biopsy modality, identified PCa in 52/60 men (86.7%) and in 27/27 men (100%) men with metastases. Using the PSMA-driven single imaging modality pathway in biopsy-naïve men at high-risk of PCa, a substantial number of diagnostic MRI scans could be avoided while at the same time obtaining adequate targeting, staging, and detection of csPCa.