Cost Analysis of Prostate Cancer Care Using a Biomarker-enhanced Diagnostic Strategy with Stockholm3.

Background and objective: Building on previous research demonstrating better prostate cancer (PC) diagnostics via a biomarker-enhanced approach, this study focuses on cost analysis of PC care using the Stockholm3 test. We assessed the economic impact in European health care systems using real-world evidence for diagnostic outcomes and relevant costs. Methods: We evaluated two PC diagnostic strategies: (1) the conventional prostate-specific antigen (PSA) strategy with magnetic resonance imaging (MRI) and (2) PSA testing with a reflex to biomarkers at PSA ≥1.5 ng/ml in guiding decisions to perform MRI. Data from the Swedish National Prostate Cancer Register and Capio St. Göran Hospital provided real-world evidence, supplemented by health economic modeling. A comprehensive cost analysis was conducted using a Markov model for treatment pathways for four PC disease states and overall spending, for which costs from various European health care systems were used. A deterministic sensitivity analysis was performed across different cost and diagnostic scenarios. Key finding and limitations: The average cost for the four disease states was €2 182 for benign disease, €10 023 for low-grade disease, €13 073 for intermediate- to high-grade localized or locally advance disease, and €271 210 for metastatic disease. The overall spending was €358 239 (7.7%) lower per 1000 men tested in the biomarker-enhanced strategy in comparison to the PSA strategy. The primary cost saving was attributed to lower treatment expenses for metastatic disease. Sensitivity analysis affirmed the robustness of the findings across various diagnostic and treatment scenarios. Conclusions and clinical implications: Biomarker-enhanced diagnostic strategies may reduce health care costs for PC management and are likely to improve quality-adjusted life years in a scenario in which metastatic disease is reduced. Patient summary: We explored different ways to detect prostate cancer more cost-effectively. We found that using a specific blood test, called Stockholm3, after a PSA (prostate-specific antigen) test to decide if an MRI scan (magnetic resonance imaging) is necessary could save money, mainly by identifying localized cancer earlier and reducing the need for expensive treatments for advanced cancer.

PI-QUAL version 2: an update of a standardised scoring system for the assessment of image quality of prostate MRI.

Multiparametric MRI is the optimal primary investigation when prostate cancer is suspected, and its ability to rule in and rule out clinically significant disease relies on high-quality anatomical and functional images. Avenues for achieving consistent high-quality acquisitions include meticulous patient preparation, scanner setup, optimised pulse sequences, personnel training, and artificial intelligence systems. The impact of these interventions on the final images needs to be quantified. The prostate imaging quality (PI-QUAL) scoring system was the first standardised quantification method that demonstrated the potential for clinical benefit by relating image quality to cancer detection ability by MRI. We present the updated version of PI-QUAL (PI-QUAL v2) which applies to prostate MRI performed with or without intravenous contrast medium using a simplified 3-point scale focused on critical technical and qualitative image parameters. CLINICAL RELEVANCE STATEMENT: High image quality is crucial for prostate MRI, and the updated version of the PI-QUAL score (PI-QUAL v2) aims to address the limitations of version 1. It is now applicable to both multiparametric MRI and MRI without intravenous contrast medium. KEY POINTS: High-quality images are essential for prostate cancer diagnosis and management using MRI. PI-QUAL v2 simplifies image assessment and expands its applicability to prostate MRI without contrast medium. PI-QUAL v2 focuses on critical technical and qualitative image parameters and emphasises T2-WI and DWI.

Performance of a Region of Interest-based Algorithm in Diagnosing International Society of Urological Pathology Grade Group ≥2 Prostate Cancer on the MRI-FIRST Database-CAD-FIRST Study.

BACKGROUND AND OBJECTIVE: Prostate multiparametric magnetic resonance imaging (MRI) shows high sensitivity for International Society of Urological Pathology grade group (GG) ≥2 cancers. Many artificial intelligence algorithms have shown promising results in diagnosing clinically significant prostate cancer on MRI. To assess a region-of-interest-based machine-learning algorithm aimed at characterising GG ≥2 prostate cancer on multiparametric MRI. METHODS: The lesions targeted at biopsy in the MRI-FIRST dataset were retrospectively delineated and assessed using a previously developed algorithm. The Prostate Imaging-Reporting and Data System version 2 (PI-RADSv2) score assigned prospectively before biopsy and the algorithm score calculated retrospectively in the regions of interest were compared for diagnosing GG ≥2 cancer, using the areas under the curve (AUCs), and sensitivities and specificities calculated with predefined thresholds (PIRADSv2 scores ≥3 and ≥4; algorithm scores yielding 90% sensitivity in the training database). Ten predefined biopsy strategies were assessed retrospectively. KEY FINDINGS AND LIMITATIONS: After excluding 19 patients, we analysed 232 patients imaged on 16 different scanners; 85 had GG ≥2 cancer at biopsy. At patient level, AUCs of the algorithm and PI-RADSv2 were 77% (95% confidence interval [CI]: 70-82) and 80% (CI: 74-85; p = 0.36), respectively. The algorithm's sensitivity and specificity were 86% (CI: 76-93) and 65% (CI: 54-73), respectively. PI-RADSv2 sensitivities and specificities were 95% (CI: 89-100) and 38% (CI: 26-47), and 89% (CI: 79-96) and 47% (CI: 35-57) for thresholds of ≥3 and ≥4, respectively. Using the PI-RADSv2 score to trigger a biopsy would have avoided 26-34% of biopsies while missing 5-11% of GG ≥2 cancers. Combining prostate-specific antigen density, the PI-RADSv2 and algorithm's scores would have avoided 44-47% of biopsies while missing 6-9% of GG ≥2 cancers. Limitations include the retrospective nature of the study and a lack of PI-RADS version 2.1 assessment. CONCLUSIONS AND CLINICAL IMPLICATIONS: The algorithm provided robust results in the multicentre multiscanner MRI-FIRST database and could help select patients for biopsy. PATIENT SUMMARY: An artificial intelligence-based algorithm aimed at diagnosing aggressive cancers on prostate magnetic resonance imaging showed results similar to expert human assessment in a prospectively acquired multicentre test database.

PRECISE Version 2: Updated Recommendations for Reporting Prostate Magnetic Resonance Imaging in Patients on Active Surveillance for Prostate Cancer.

BACKGROUND AND OBJECTIVE: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations standardise the reporting of prostate magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer. An international consensus group recently updated these recommendations and identified the areas of uncertainty. METHODS: A panel of 38 experts used the formal RAND/UCLA Appropriateness Method consensus methodology. Panellists scored 193 statements using a 1-9 agreement scale, where 9 means full agreement. A summary of agreement, uncertainty, or disagreement (derived from the group median score) and consensus (determined using the Interpercentile Range Adjusted for Symmetry method) was calculated for each statement and presented for discussion before individual rescoring. KEY FINDINGS AND LIMITATIONS: Participants agreed that MRI scans must meet a minimum image quality standard (median 9) or be given a score of 'X' for insufficient quality. The current scan should be compared with both baseline and previous scans (median 9), with the PRECISE score being the maximum from any lesion (median 8). PRECISE 3 (stable MRI) was subdivided into 3-V (visible) and 3-NonV (nonvisible) disease (median 9). Prostate Imaging Reporting and Data System/Likert ≥3 lesions should be measured on T2-weighted imaging, using other sequences to aid in the identification (median 8), and whenever possible, reported pictorially (diagrams, screenshots, or contours; median 9). There was no consensus on how to measure tumour size. More research is needed to determine a significant size increase (median 9). PRECISE 5 was clarified as progression to stage ≥T3a (median 9). CONCLUSIONS AND CLINICAL IMPLICATIONS: The updated PRECISE recommendations reflect expert consensus opinion on minimal standards and reporting criteria for prostate MRI in AS. PATIENT SUMMARY: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations are used in clinical practice and research to guide the interpretation and reporting of magnetic resonance imaging for patients on active surveillance for prostate cancer. An international panel has updated these recommendations, clarified the areas of uncertainty, and highlighted the areas for further research.

Multiparametric Magnetic Resonance Imaging in the follow-up of non-muscle-invasive bladder tumors after intravesical instillations: a promising tool.

PURPOSE: The standard follow-up for non-muscle-invasive bladder cancer is based on cystoscopy. Unfortunately, post-instillation inflammatory changes can make the interpretation of this exam difficult, with lower specificity. This study aimed to evaluate the interest of bladder MRI in the follow-up of patients following intravesical instillation. METHODS: Data from patients who underwent cystoscopy and bladder MRI in a post-intravesical instillation setting between February 2020 and March 2023 were retrospectively collected. Primary endpoint was to evaluate and compare the diagnostic performance of cystoscopy and bladder MRI in the overall cohort (n = 67) using the pathologic results of TURB as a reference. The secondary endpoint was to analyze the diagnostic accuracy of cystoscopy and bladder MRI according to the appearance of the lesion on cystoscopy [flat (n = 40) or papillary (n = 27)]. RESULTS: The diagnostic performance of bladder MRI was better than that of cystoscopy, with a specificity of 47% (vs. 6%, p < 0.001), a negative predictive value of 88% (vs. 40%, p = 0.03), and a positive predictive value of 66% (vs. 51%, p < 0.001), whereas the sensitivity did not significantly differ between the two exams. In patients with doubtful cystoscopy and negative MRI findings, inflammatory changes were found on TURB in most cases (17/19). The superiority in MRI bladder performance prevailed for "flat lesions", while no significant difference was found for "papillary lesions". CONCLUSIONS: In cases of doubtful cystoscopy after intravesical instillations, MRI appears to be relevant with good performance in differentiating post-therapeutic inflammatory changes from recurrent tumor lesions and could potentially allow avoiding unnecessary TURB.

European Association of Nuclear Medicine Focus 5: Consensus on Molecular Imaging and Theranostics in Prostate Cancer.

BACKGROUND: In prostate cancer (PCa), questions remain on indications for prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging and PSMA radioligand therapy, integration of advanced imaging in nomogram-based decision-making, dosimetry, and development of new theranostic applications. OBJECTIVE: We aimed to critically review developments in molecular hybrid imaging and systemic radioligand therapy, to reach a multidisciplinary consensus on the current state of the art in PCa. DESIGN, SETTING, AND PARTICIPANTS: The results of a systematic literature search informed a two-round Delphi process with a panel of 28 PCa experts in medical or radiation oncology, urology, radiology, medical physics, and nuclear medicine. The results were discussed and ratified in a consensus meeting. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Forty-eight statements were scored on a Likert agreement scale and six as ranking options. Agreement statements were analysed using the RAND appropriateness method. Ranking statements were analysed using weighted summed scores. RESULTS AND LIMITATIONS: After two Delphi rounds, there was consensus on 42/48 (87.5%) of the statements. The expert panel recommends PSMA PET to be used for staging the majority of patients with unfavourable intermediate and high risk, and for restaging of suspected recurrent PCa. There was consensus that oligometastatic disease should be defined as up to five metastases, even using advanced imaging modalities. The group agreed that [177Lu]Lu-PSMA should not be administered only after progression to cabazitaxel and that [223Ra]RaCl2 remains a valid therapeutic option in bone-only metastatic castration-resistant PCa. Uncertainty remains on various topics, including the need for concordant findings on both [18F]FDG and PSMA PET prior to [177Lu]Lu-PSMA therapy. CONCLUSIONS: There was a high proportion of agreement among a panel of experts on the use of molecular imaging and theranostics in PCa. Although consensus statements cannot replace high-certainty evidence, these can aid in the interpretation and dissemination of best practice from centres of excellence to the wider clinical community. PATIENT SUMMARY: There are situations when dealing with prostate cancer (PCa) where both the doctors who diagnose and track the disease development and response to treatment, and those who give treatments are unsure about what the best course of action is. Examples include what methods they should use to obtain images of the cancer and what to do when the cancer has returned or spread. We reviewed published research studies and provided a summary to a panel of experts in imaging and treating PCa. We also used the research summary to develop a questionnaire whereby we asked the experts to state whether or not they agreed with a list of statements. We used these results to provide guidance to other health care professionals on how best to image men with PCa and what treatments to give, when, and in what order, based on the information the images provide.

Prehabilitation in Urology: Trial Update.

While prehabilitation is on the verge of being a standard of care, ENHANCE is a pragmatic trial to further improve treatment of urologic cancers with an indication for surgery. The PRIMER trial and a Belgian randomized study will focus on the feasibility of at-home prehabilitation.

Is imaging accurate enough to detect index lesion in prostate cancer? Analysis of the performance of MRI and other imaging modalities.

Prostate imaging techniques have progressed across the years allowing for a better detection and characterization of prostate cancer (PCa) lesions. These advancements have led to the possibility to also improve and tailor the treatments on the most aggressive lesion, defined as Index Lesion (IL), to reduce morbidity. The IL is, indeed, considered as the entity which encompass the most aggressive features in prostate cancer disease. Multiparametric magnetic resonance imaging (mpMRI) has emerged as the suggested tool to detect the disease and plan treatments, including those under investigation such as focal therapy (FT). Our review aimed to query the literature on the ability of mpMRI in IL detection and to explore the future perspectives in PCa IL diagnosis. A review of the literature was performed from January 2010 to July 2023. All studies investigating the performance of mpMRI and other main imaging techniques able to detect the IL were assessed and evaluated. mpMRI performs well in the detection of IL with a sensitivity which reaches 71% to 94% among the different studies. However, mpMRI seems to have limited sensitivity in the detection of small tumours (<0.5 mL) and low-grade histology lesions. To overcome these limitations other diagnostic imaging techniques have been proposed. Multiparametric Ultrasound has shown results comparable to mpMRI while detecting 4.3% fewer clinically significant PCa (P=0.042). Positron emission tomography-based modalities using PSMA seems to have higher sensitivity than mpMRI, being able to yield from 13.5% to 18.2% additional cancers. MRI has emerged as the recommended tool since most of the IL can be easily identified, and is the imaging of choice while selecting patients for FT. Other imaging modalities has been proposed to improve PCa lesions detection, but results need to be confirmed by ongoing randomized controlled trial.

A Multicentre Clinical Trial Evaluating a Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer.

BACKGROUND: This study evaluated the safety and performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node biopsy (SeLNB) in a prospective, open-label, multicentre, single-arm clinical trial. OBJECTIVE: The main objective was to determine the sentinel lymph node (SeLN) detection rate with the drop-in gamma probe system. The secondary objectives were overall performance and safety. DESIGN, SETTING, AND PARTICIPANTS: At three European centres, patients received an ultrasound-guided systemic and tumour-targeted injection of [99mTc]Tc-nanocolloid followed by planar lymphoscintigraphy and/or single-photon emission computerised tomography. The next day, manual laparoscopic or robot-assisted radical prostatectomy was performed, including SeLN dissection (SeLND) and extended pelvic lymph node dissection (ePLND). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: SeLNs were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). The primary endpoint of the study was the SeLND rate defined as the percentage of patients with at least one SeLN detected in vivo by the drop-in probe. The secondary endpoints included diagnostic performance, ease of SeLN detection, number of SeLNs detected, and safety. The first two patients at each site (six in total) were used for familiarisation. RESULTS AND LIMITATIONS: A total of 27 patients were included in the main analysis. SENSEI successfully detected at least one SeLN in all 27 patients, resulting in a detection rate of 100% (95% confidence interval 87.2-100%). The total number of SeLNs identified with SENSEI was 85 (median three SeLNs per patient, range 1-6); of these 85 SeLNs, 12 were located outside of the ePLND template. In the nine patients in whom the RLGP was used, SENSEI detected two SeLNs that could not be detected with the RLGP due to manoeuvrability restrictions. Ten of the 27 patients were pN1; four patients had a false-negative SeLNB. No adverse events or complications were related to the use of the drop-in probe. CONCLUSIONS: The study demonstrated that the drop-in gamma probe meets the performance and safety requirements for SeLNB in PCa. The device provided improved manoeuvrability and SeLN detection compared with the conventional RLGP. PATIENT SUMMARY: A novel device was tested for detecting sentinel lymph nodes during minimally invasive surgery for prostate cancer. In this first evaluation, the performance and safety of the device were evaluated positively.

Retrospective Evaluation of a Single Surgeon's Learning Curve of Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion via Ileal Conduit.

Robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) is increasingly being performed instead of open surgery. A criticism of this technique is the long learning curve, but limited data are available on this topic. At our center, the transition from open radical cystectomy (ORC) to iRARC began in May 2017. A retrospective analysis was conducted on the initial 53 cases of robot-assisted cystectomy with intracorporeal urinary diversion via ileal conduit, which were performed by one single surgeon. The patients were divided into four consecutive groups according to the surgeon's increasing experience, and perioperative parameters were analyzed as a surrogate for the learning curve. Over the course of the learning curve, a decline in median operation time from 415 to 361 min (p = 0.02), blood loss from 400 to 200 mL (p = 0.01), and minor complications from 71% to 15% (p = 0.02) was observed. No significant difference in overall and major complications, length of hospital stay, and total lymph node yield was shown. During the initial period of the learning curve, only the less complex cases were operated on using robotic surgery, while the more challenging ones were handled through open surgery. After experience with 28 cases, no more cystectomies were performed through open surgery. This led to an increase in operation time and length of hospital stay, as well as a higher incidence of both minor and overall complications among cases 28-40. After 40 cases, a significant decrease in these parameters was observed again. Our analysis demonstrated that operation time, blood loss, and minor complications decrease with increasing surgical experience in iRARC, while suggesting that technically challenging cases should be operated on after experience with 40 robotic cystectomies.

Urinary MicroRNAs as Biomarkers of Urological Cancers: A Systematic Review.

MicroRNAs (miRNAs) are emerging as biomarkers for the detection and prognosis of cancers due to their inherent stability and resilience. To summarize the evidence regarding the role of urinary miRNAs (umiRNAs) in the detection, prognosis, and therapy of genitourinary cancers, we performed a systematic review of the most important scientific databases using the following keywords: (urinary miRNA) AND (prostate cancer); (urinary miRNA) AND (bladder cancer); (urinary miRNA) AND (renal cancer); (urinary miRNA) AND (testicular cancer); (urinary miRNA) AND (urothelial cancer). Of all, 1364 articles were screened. Only original studies in the English language on human specimens were considered for inclusion in our systematic review. Thus, a convenient sample of 60 original articles was identified. UmiRNAs are up- or downregulated in prostate cancer and may serve as potential non-invasive molecular biomarkers. Several umiRNAs have been identified as diagnostic biomarkers of urothelial carcinoma and bladder cancer (BC), allowing us to discriminate malignant from nonmalignant forms of hematuria. UmiRNAs could serve as therapeutic targets or recurrence markers of non-muscle-invasive BC and could predict the aggressivity and prognosis of muscle-invasive BC. In renal cell carcinoma, miRNAs have been identified as predictors of tumor detection, aggressiveness, and progression to metastasis. UmiRNAs could play an important role in the diagnosis, prognosis, and therapy of urological cancers.

Post-chemotherapy robot-assisted retroperitoneal lymph node dissection for metastatic germ cell tumors: safety and perioperative outcomes.

PURPOSE: To evaluate the feasibility, safety, and early oncologic outcomes after post-chemotherapy robot-assisted retroperitoneal lymph node dissection (PC-RARPLND) for metastatic germ cell tumors (mGCT). METHODS: We retrospectively analyzed patients from four tertiary centers who underwent PC-RARPLND for mGCT, from 2011 to 2021. Previous treatment of mGCT, intraoperative and postoperative complications, and early oncologic outcomes were assessed. RESULTS: Overall, 66 patients were included. The majority of patients had non-seminoma mTGCT (89%). Median size of retroperitoneal lymph node (RLN) before surgery was 26 mm. Templates of PC-RARPLND were left modified, right modified, and full bilateral in 56%, 27%, and 14%, respectively. Median estimated blood loss and length of stay were 50 mL [50-150] and 2 [1-3] days. Four patients (6.1%) had a vascular injury, only one with significant blood loss and conversion to open surgery (OS). Two other patients had a conversion to OS for difficulty of dissection. No patient had transfusion, most frequent complications were ileus (10.6%) and symptomatic lymphorrea (7.6%) and no complications grade IIIb or more occurred. With a median follow-up of 16 months, two patients had a relapse, all outside of the surgical template (one in the retrocrural space with reascending markers, one in lungs). CONCLUSION: PC-RARPLND is a challenging surgery. In expert centers and for selected patients, it seemed safe and feasible, with a low morbidity. Further prospective evaluation of this procedure and long-term oncologic results are needed.

Primary Whole-gland Ablation for the Treatment of Clinically Localized Prostate Cancer: A Focal Therapy Society Best Practice Statement.

CONTEXT: Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. OBJECTIVE: To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. EVIDENCE ACQUISITION: We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. EVIDENCE SYNTHESIS: Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. CONCLUSIONS: The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. PATIENT SUMMARY: Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.

Baseline Serum Prostate-specific Antigen Value Predicts the Risk of Subsequent Prostate Cancer Death-Results from the Norwegian Prostate Cancer Consortium.

BACKGROUND: Prostate-specific antigen (PSA) levels in midlife are strongly associated with the long-term risk of lethal prostate cancer in cohorts not subject to screening. This is the first study evaluating the association between PSA levels drawn as part of routine medical care in the Norwegian population and prostate cancer incidence and mortality. OBJECTIVE: To determine the association between midlife PSA levels <4.0 ng/ml, drawn as part of routine medical care, and long-term risk of prostate cancer death. DESIGN, SETTING, AND PARTICIPANTS: The Norwegian Prostate Cancer Consortium collected >8 million PSA results from >1 million Norwegian males ≥40 yr of age. We studied 176 099 men (predefined age strata: 40-54 and 55-69 yr) without a prior prostate cancer diagnosis who had a nonelevated baseline PSA level (<4.0 ng/ml) between January 1, 1995 and December 31, 2005. INTERVENTION: Baseline PSA. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We assessed the 16-yr risk of prostate cancer mortality. We calculated the discrimination (C-index) between predefined PSA strata (<0.5, 0.5-0.9, 1.0-1.9, 2.0-2.9, and 3.0-3.9 ng/ml) and subsequent prostate cancer death. Survival curves were plotted using the Kaplan-Meier method. RESULTS AND LIMITATIONS: The median follow-up time of men who did not get prostate cancer was 17.9 yr. Overall, 84% of men had a baseline PSA level of <2.0 ng/ml and 1346 men died from prostate cancer, with 712 deaths (53%) occurring in the 16% of men with the highest baseline PSA of 2.0-3.9 ng/ml. Baseline PSA levels were associated with prostate cancer mortality (C-index 0.72 for both age groups, 40-54 and 55-69 yr). The fact that the reason for any given PSA measurement remains unknown represents a limitation. CONCLUSIONS: We replicated prior studies that baseline PSA at age 40-69 yr can be used to stratify a man's risk of dying from prostate cancer within the next 15-20 yr. PATIENT SUMMARY: A prostate-specific antigen level obtained as part of routine medical care is strongly associated with a man's risk of dying from prostate cancer in the next two decades.

Bibliometric analysis of academic journal recommendations and requirements for surgical and anesthesiologic adverse events reporting.

BACKGROUND: Standards for reporting surgical adverse events (AEs) vary widely within the scientific literature. Failure to adequately capture AEs hinders efforts to measure the safety of healthcare delivery and improve the quality of care. The aim of the present study is to assess the prevalence and typology of perioperative AE reporting guidelines among surgery and anesthesiology journals. MATERIALS AND METHODS: In November 2021, three independent reviewers queried journal lists from the SCImago Journal & Country Rank (SJR) portal (www.scimagojr.com), a bibliometric indicator database for surgery and anesthesiology academic journals. Journal characteristics were summarized using SCImago, a bibliometric indicator database extracted from Scopus journal data. Quartile 1 (Q1) was considered the top quartile and Q4 bottom quartile based on the journal impact factor. Journal author guidelines were collected to determine whether AE reporting recommendations were included and, if so, the preferred reporting procedures. RESULTS: Of 1409 journals queried, 655 (46.5%) recommended surgical AE reporting. Journals most likely to recommend AE reporting were: by category surgery (59.1%), urology (53.3%), and anesthesia (52.3%); in top SJR quartiles (i.e. more influential); by region, based in Western Europe (49.8%), North America (49.3%), and the Middle East (48.3%). CONCLUSIONS: Surgery and anesthesiology journals do not consistently require or provide recommendations on perioperative AE reporting. Journal guidelines regarding AE reporting should be standardized and are needed to improve the quality of surgical AE reporting with the ultimate goal of improving patient morbidity and mortality.

Is CIS a Contraindication to Hyperthermic Intravesical Chemotherapy (HIVEC) after BCG-Failure?

CIS of the bladder is associated with a high risk of progression. In the case of BCG failure, radical cystectomy should be performed. For patients who refuse or are ineligible, bladder-sparing alternatives are evaluated. This study aims to investigate the efficacy of Hyperthermic IntraVesical Chemotherapy (HIVEC) depending on the presence or absence of CIS. This retrospective, multicenter study was conducted between 2016 and 2021. Patients with non-muscle-invasive bladder cancer (NMIBC) with BCG failure received 6-8 adjuvant instillations of HIVEC. The co-primary endpoints were recurrence-free survival (RFS) and progression-free survival (PFS). A total of 116 consecutive patients met our inclusion criteria of whom 36 had concomitant CIS. The 2-year RFS rate was 19.9% and 43.7% in patients with and without CIS, respectively (p = 0.52). Fifteen patients (12.9%) experienced progression to muscle-invasive bladder cancer with no significant difference between patients with and without CIS (2-year PFS rate = 71.8% vs. 88.8%, p = 0.32). In multivariate analysis, CIS was not a significant prognostic factor in terms of recurrence or progression. In conclusion, CIS may not be considered a contraindication to HIVEC, as there is no significant association between CIS and the risk of progression or recurrence after treatment.

A Giant Paratesticular Liposarcoma: Case Report and Literature Review.

Liposarcoma of the spermatic cord (LSC) is a very rare disease. In literature, are reported less than 350 cases. Genitourinary sarcomas account for <5% of all soft-tissue sarcomas and <2% of malignant urologic tumours. An inguinal mass is the clinical presentation, which can mimic a hernia or hydrocele. Since it is such a rare disease, there are insufficient data on chemotherapy and radiotherapy, and in any case, the data come from low-level scientific evidence. Here, we report the case of a patient who came to the observation for a giant inguinal mass, in which a definitive diagnosis was obtained with the histological examination.

Efficacy of hyperthermic intravesical chemotherapy (HIVEC) in patients with non-muscle invasive bladder cancer after BCG failure.

PURPOSE: To evaluate hyperthermic intravesical chemotherapy (HIVEC) efficacy regarding 1-year disease-free survival (RFS) rate and bladder preservation rate in patients with non-muscle invasive bladder cancer (NMIBC) who fail bacillus Calmette-Guérin (BCG) therapy. METHODS: This is a multicenter retrospective series from a national database (7 expert centers). Between January 2016 and October 2021, patients treated with HIVEC for NMIBC who failed BCG have been included in our study. These patients had a theoretical indication for cystectomy but were ineligible for surgery or refused it. RESULTS: A total of 116 patients treated with HIVEC and with a follow-up > 6 months were included in this study and retrospectively analyzed. The median follow-up was 20.6 months. The 12 month-RFS (recurrence-free survival) rate was 62.9%. The bladder preservation rate was 87.1%. Fifteen patients (12.9%) progressed to muscle infiltration, three of them having a metastatic disease at the time of progression. Predictive factors of progression were T1 stage, high grade and very high-risk tumors according to the EORTC classification. CONCLUSION: Chemohyperthermia using HIVEC achieved an RFS rate of 62.9% at 1 year and enabled a bladder preservation rate of 87.1%. However, the risk of progression to muscle-invasive disease is not negligible, particularly for patients with very high-risk tumors. In these patients who fail BCG, cystectomy should remain the standard of care and HIVEC may be discussed cautiously for patients who are not eligible for surgery and well informed of the risk of progression.