Objective: To determine the value of preoperative frailty screening in predicting postoperative severe complications and 1‐year mortality in patients undergoing radical cystectomy (RC). Patients and Methods: Prospective cohort single‐centre study in patients undergoing RC from September 2016 to December 2017. Preoperative frailty screening was implemented as standard care and was used to guide shared decision‐making during multidisciplinary team meetings. Frailty screening consisted of validated tools to assess physical, mental and social frailty. Patients were considered frail when having two or more frailty characteristics. The primary endpoint was the composite of a severe complication (Clavien–Dindo Grade III–V) within 30 days and 1‐year all‐cause mortality. The secondary endpoints included any complication (Clavien–Dindo II–V), length of stay, readmission within 30 days, and all‐cause mortality. Logistic regression analysis and the concordance statistic (c‐statistic) were used to describe the association and predictive value of preoperative frailty screening. Results: A total of 63 patients were included; 39 (61.9%) were considered frail. Preoperative frailty was associated with a seven‐fold increased risk of a severe complication or death 1 year after RC [adjusted odds ratio (OR) 7.36, 95% confidence interval (CI) 1.7–31.8; 22 patients]. Compared to the American Society of Anesthesiologists (ASA) score and Charlson Comorbidity Index, frailty showed the best model performance (Nagelkerke R2 0.20) and discriminative ability(c‐statistic 0.72, P < 0.01) for the primary endpoint. After adding frailty to the conventional ASA risk score, the c‐statistic improved by 11% ( P < 0.01). Overall survival was significantly worse in frail patients (23.2 months, 95% CI 18.7–30.1) vs non‐frail patients (32.9 months, 95% CI 30.0–35.9; P = 0.01). Conclusions: Frail patients undergoing RC are at high risk of postoperative adverse outcomes including death. Preoperative frailty screening improves preoperative risk stratification and may be used to guide patient selection for RC.
Bleeding disorders or the use of anticoagulant medication are contraindications to transurethral prostate resection in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). Laser prostatectomy has proved to be adequate surgical therapy with less blood loss than transurethral prostate resection. A prospective, controlled study was done in patients at high risk (HR) with LUTS suggestive of BPH. They were treated with contact laser prostatectomy (CLP) or the combination of CLP with visual laser ablation prostatectomy (VLAP). HR was defined as bleeding disorders or anticoagulants use. As a control, men at normal risk with LUTS suggestive of BPH were treated with CLP. Patients completed validated questionnaires and underwent urodynamics at baseline and 6 months postoperatively. A total of 75 patients were included, namely 19 in the HR-CLP group, 11 in the HR-CLP-VLAP group and 45 in the normal risk CLP group. Obstruction relief, and symptomatic and subjective improvement were equal in all 3 groups. Effective capacity (maximum cystometric capacity minus post-void residual volume) also improved significantly in all except the HR-CLP group. Maximum urine flow improved in all groups but not significantly in the HR-CLP group. Intraoperative and postoperative complications were slightly higher in HR cases. However, blood transfusion was never necessary and there was no mortality. CLP and especially CLP-VLAP perform almost as well in HR cases compared with CLP in those at normal risk. These procedures are safe for men at HR with LUTS suggestive of BPH.
Adequate detection of the histopathological extraprostatic extension (EPE) of prostate cancer (PCa) remains a challenge using conventional radiomics on 3 Tesla multiparametric magnetic resonance imaging (3T mpMRI). This study focuses on the assessment of artificial intelligence (AI)-driven models with innovative MRI radiomics in predicting EPE of prostate cancer (PCa) at a lesion-specific level. With a dataset encompassing 994 lesions from 794 PCa patients who underwent robot-assisted radical prostatectomy (RARP) at two Dutch hospitals, the study establishes and validates three classification models. The models were validated on an internal validation cohort of 162 lesions and an external validation cohort of 189 lesions in terms of discrimination, calibration, net benefit, and comparison to radiology reporting. Notably, the achieved AUCs ranged from 0.86 to 0.91 at the lesion-specific level, demonstrating the superior accuracy of the random forest model over conventional radiological reporting. At the external test cohort, the random forest model was the best-calibrated model and demonstrated a significantly higher accuracy compared to radiological reporting (83% vs. 67%, p = 0.02). In conclusion, an AI-powered model that includes both existing and novel MRI radiomics improves the detection of lesion-specific EPE in prostate cancer.
Background: Despite its high specificity, PSMA PET/CT has a moderate to low sensitivity of 40–50% for pelvic lymph node detection, implicating that a negative PSMA PET/CT cannot rule out lymph node metastases. This study investigates a strategy of implementing PSMA PET/CT for initial prostate cancer staging and treatment planning compared to conventional diagnostics. In this PSMA PET/CT strategy, a bilateral extended pelvic lymph node dissection (ePLND) is only performed in case of a negative PSMA PET/CT; in case of a positive scan treatment planning is solely based on PSMA PET/CT results. Method: A decision table and lifetime state transition model were created. Quality-adjusted life years and health care costs were modelled over lifetime. Results: The PSMA PET/CT strategy of treatment planning based on initial staging with [68Ga]Ga-PSMA-11 PET/CT results in cost-savings of €674 and a small loss in quality of life (QoL), 0.011 QALY per patient. The positive effect of [68Ga]Ga-PSMA-11 PET/CT was caused by abandoning both an ePLND and unnecessary treatment in iM1 patients, saving costs and resulting in higher QoL. The negative effect was caused by lower QoL and high costs in the false palliative state, due to pN1lim patients (≤ 4 pelvic lymph node metastases) being falsely diagnosed as iN1ext (> 4 pelvic lymph node metastases). These patients received subsequently palliative treatment instead of potentially curative therapy. Conclusion: Initial staging and treatment planning based on [68Ga]Ga-PSMA-11 PET/CT saves cost but results in small QALY loss due to the rate of false positive findings.
Purpose: To describe the development and first outcomes of the Utrecht Prostate Cohort (UPC): the first ‘trials within cohorts’ (TwiCs) platform for prostate cancer (PCa). Methods: All non-metastasized, histologically proven PCa patients who are planned to receive standard of care are eligible for inclusion in UPC. Patients provide informed consent for the collection of clinical and technical patient data, physician-reported outcomes, and patient-reported outcomes (PROs) up to 10 years post-treatment. Additionally, patients may provide broad consent for future randomization for experimental-intervention trials (TwiCs). Changes in PROs (EPIC-26 questionnaire domains) of the participants who received standard of care were analyzed using Wilcoxon signed-rank tests. Results: In two years, 626 patients were enrolled, 503 (80.4%) of whom provided broad consent for future randomization. Among these, 293 (46.8%) patients underwent magnetic resonance-guided adaptive radiotherapy (MRgRT), 116 (18.5%) CT-guided external beam radiation therapy (EBRT), 109 (17.4%) robot-assisted radical prostatectomy (RARP), and 65 (10.4%) patients opted for active surveillance. Patients treated with MRgRT and CT-guided EBRT showed a transient but significant decline in urinary irritative/obstructive and bowel domain scores at 1-month follow-up. RARP patients showed a significant deterioration of urinary incontinence domain scores between baseline and all follow-up moments and significant improvement of urinary irritative/obstructive domain scores between baseline and 9- and 12-month follow-up. All radical treatment groups showed a significant decline in sexual domain scores during follow-up. Active surveillance patients showed no significant deterioration over time in all domains. Conclusion: The first results from the UPC study show distinct differences in PROs between treatment options for PCa. Registration No.: NCT04228211.