Personalised indocyanine-guided lymphadenectomy for prostate cancer: a randomised clinical trial.

OBJECTIVES: To study the safety and efficacy of a personalised indocyanine-guided pelvic lymph node dissection (PLND) against extended PLND (ePLND) during radical prostatectomy (RP). PATIENTS AND METHODS: Patients who were candidates for RP and lymphadenectomy, with intermediate- or high-risk prostate cancer (PCa) according to the National Comprehensive Cancer Network guidelines, were enrolled in this randomised clinical trial. Randomisation was made 1:1 to indocyanine green (ICG)-PLND (only ICG-stained LNs) or ePLND (obturator fossa, external, internal, and common iliac and presacral LNs). The primary endpoint was the complication rate within 3 months after RP. Secondary endpoints included: rate of major complications (Clavien-Dindo Grade III-IV), time to drainage removal, length of stay, percentage of patients classified as pN1, number of LNs removed, number of metastatic LNs, rate of patients with undetectable prostate-specific antigen (PSA), biochemical recurrence (BCR)-free survival, and rate of patients with androgen-deprivation therapy at 24 months. RESULTS: A total of 108 patients were included with a median follow-up of 16 months. In all, 54 were randomised to ICG-PLND and 54 to ePLND. The postoperative complication rate was higher in the ePLND (70%) vs the ICG-PLND group (32%) (P < 0.001). Differences between major complications in both groups were not statically significant (P = 0.7). The pN1 detection rate was higher in the ICG-PLND group (28%) vs the ePLND group (22%); however, this difference was not statistically significant (P = 0.7). The rate of undetectable PSA at 12 months was 83% in the ICG-PLND vs 76% in the ePLND group, which was not statistically significant. Additionally, there were no statistically significant differences in BCR-free survival between groups at the end of the analysis. CONCLUSIONS: Personalised ICG-guided PLND is a promising technique to stage patients with intermediate- and high-risk PCa properly. It has shown a lower complication rate than ePLND with similar oncological outcomes at short-term follow-up.

Is Unilateral Lymphadenectomy an Option in Selected Patients with Prostate Cancer?

BACKGROUND: Evidence regarding the relationship between the laterality of lymph node invasion (LNI) and the prostatic lobe affected is limited. Our aim was to review our records of patients with exclusively unilateral localised prostate cancer (PCa) with metastatic LN involvement. METHODS: Between 2006 and 2023, after radical prostatectomy and extended pelvic lymphadenectomy at our centre, thirty patients with intermediate-high risk unilateral PCa and pN1 disease were identified. To perform a retrospective study, data were obtained from a prospective collected database approved by the ethical committee at the Valencian Oncology Institute Foundation. Descriptive and comparative statistical analysis was made using software R. The Fisher's Exact test was employed to analyse the categorical variables. In terms of continuous variables, both tumour volume and number of nodes retrieved exhibited normality; Hence Student's T-test was employed. Mann-Whitney U test was utilized for the number of positive nodes. RESULTS: The median age and prostate specific antigen (PSA) at diagnosis were 66 years old (interquartile range (IQR): 63.3-70.9) and 14.6 ng/mL (IQR: 7.4-21.5), respectively. Median follow-up time was 67 months (IQR: 35.9-92.9). Nineteen patients (63%) had a Gleason score of 7, and the rest had a Gleason score of 8-10. Most patients (73%) had locally advanced disease. Baseline characteristics were comparable between groups (p-value > 0.05). Twenty-two patients (73%) had concordance between the laterality of the PCa lesion and the LNI. All the patients with right prostatic cancer had exclusive ipsilateral LNI. CONCLUSIONS: In our experience, the majority of patients with unilateral PCa had exclusively ipsilateral LNI. However, sparing contralateral LN dissection in unilateral PCa should not be an option. To date, extended pelvic LN dissection remains the gold standard for N-staging and cannot be replaced yet by unilateral pelvic LN dissection until high quality evidence supports this scenario.

Prostate cancer patients with lymphatic node involvement detected by immunohistochemistry. Is the effort worthwhile?

INTRODUCTION: Lymph node (LN) status is one of the main prognostic factors in localized prostate cancer (CaP) patients after surgery. Examining palpable lymph nodes with hematoxylin and eosin (HE) is the most common approach in clinical practice; however, immunohistochemistry (IHC) has been reported to increase the LN detection rate. We reviewed the oncological results of patients with LN metastasis detected by IHC. METHODS: Retrospective study of CaP patients who underwent lymphadenectomy at the time of the prostatectomy. Extended lymphadenectomy was performed with complementary indocyanine green (ICG) guidance. Three groups were considered according to LN status. Definition of the pN+ group was made if LNs were detected by HE, occulted lymph node-positive (OLN+) was considered when ≥ 1 LN was identified with IHC and occulted lymph node-negative (OLN-) if no metastatic nodes were found. Oncological outcomes were reported regarding PSA kinetics, biochemical recurrence (BCR), need for secondary treatments and metastasis-free survival (MFS). RESULTS: A total of 283 patients with a median follow-up of 69 months were included in the study. Immunohistochemical assessment revealed metastatic LNs in 8.9% of patients. The rate of locally advanced disease and positive surgical margins was higher in the OLN + and pN + groups vs the OLN - group (P < 0.05). At the end of follow-up, 19%, 44% and 52% of patients from the OLN -, OLN + and pN + groups experienced BCR (P < 0.001), respectively. Additionally, 2.6%, 17% and 22% of patients developed metastatic progression from the OLN -, OLN + and pN+ group (P < 0.001), respectively. In the multivariate analysis, the OLN + group had a higher risk HR: 12 (95% CI, 2.4-56; P = 0.002) of metastatic progression in comparison with OLN - patients. This difference was not observed in the risk of biochemical recurrence HR 1.8 (95% CI, 0.9-3.8; P = 0.09). CONCLUSION: Conventional HE histological analysis underdiagnosed nearly 10% of patients. IHC-detected patients were at higher risk of metastasis development than OLN - patients. This report highlights the importance of optimizing the anatomopathological analysis properly.

Real-world prostate-specific antigen reduction and survival outcomes of metastatic hormone-sensitive prostate cancer patients treated with apalutamide: An observational, retrospective, and multicentre study.

Background: Metastatic hormone-sensitive prostate cancer (mHSPC) treatment has changed drastically during the last years with the emergence of androgen receptor-targeted agents (ARTAs). ARTA combined with androgen deprivation therapy has demonstrated better oncological and survival outcomes in these patients. However, the optimal choice among different ARTAs remains uncertain due to their analogous efficacy. Objectives: The objective of this study was to describe prostate-specific antigen (PSA) response and oncological outcomes of patients with mHSPC treated with apalutamide. Material and methods: Medical records from three different hospitals in Spain were used to conduct this study. Patients diagnosed with mHSPC and under apalutamide treatment were included between March 2021 and January 2023. Data regarding PSA response, overall survival (OS), and radiographic progression-free survival (rPFS) were collected and stratified by metastasis volume, timing, and stating. Results: 193 patients were included; 34.2% of patients were de novo mHSPC, and the majority was classified as m1b. The 18-month OS and rPFS were 92.5% and 88.9%, respectively. Patients with PSA levels ≤0.2 ng/ml showcased an 18-month OS rate of 98.7%, contrasting with 65.3% for those with PSA >0.2 ng/ml. Similar trends emerged for rPFS (97.4% and 53.7%, respectively). When differentiating between low-volume and high-volume metastasis, the OS rate stood at 98.4% and 80.7%, respectively, while the rPFS rates were 93% and 81.6%, respectively. No significant differences were found between groups stratified by metastasis timing. Conclusion: This real-world study on patients with mHSPC treated with apalutamide plus androgen deprivation therapy revealed robust oncological outcomes, aligning with the emerging evidence. The study's hallmark finding highlights the significance of rapid and deep PSA response as a predictor of improved oncological and survival outcomes.

Sentinel Lymph Node Biopsy in Prostate Cancer: An Overview of Diagnostic Performance, Oncological Outcomes, Safety, and Feasibility.

Sentinel node biopsy (SNB) for prostate cancer (PCa) represents an innovative technique aimed at improving nodal staging accuracy. The routinary adoption of this procedure in patients undergoing radical prostatectomy (RP) might be crucial to identify candidates who could effectively benefit from extensive pelvic lymph nodal dissection (ePLND). Despite some promising results, SNB for PCa is still considered experimental due to the lack of solid evidence and procedural standardization. In this regard, our narrative review aimed to analyze the most recent literature in this field, providing an overview of both the diagnostic accuracy measures and the oncological outcomes of SNB.

Free-indocyanine green-guided pelvic lymph node dissection during radical prostatectomy.

INTRODUCTION AND OBJECTIVES: Extended Pelvic Lymph Node Dissection (ePLND) remains the most accurate technique for the detection of occult lymph node metastases (LNMs) in prostate cancer (CaP) patients. Here we aim to examine whether free-Indocyanine Green (F-ICG) could accurately assess the pathological nodal (pN) status in CaP patients during real-time lymphangiography as a potential replacement for ePLND. MATERIALS AND METHODS: 219 consecutive patients undergoing F-ICG-guided PLND, ePLND and radical prostatectomy (RP) for clinical-localized CaPwere included in this prospective single-center study. The pathological outcomes of F-ICG-guided PLND were compared to confirmatory ePLND. Parameters of a binary diagnostic test for the proper classification of the pN status of patients ('per-patient' analysis) and for the probability of detecting all the metastatic LNs ('per-node' analysis) were calculated. Outcome measures were prevalence, accuracy (Acc), sensitivity (Se), negative predictive value (NPV), and likelihood ratio of a negative F-ICG-guided PLND test result [LR(-)]. RESULTS: F-ICG-guided PLND successfully visualized LNs in all procedures with no adverse events. The overall per-patient F-ICG staging Acc was 97.7%, Se was 91.4%, with a NPV of 97.0%, and LR(-) of 8.6%. At the overall per-node level, 4,780 LNs were removed and 1,535 (32.1%) were fluorescent in vivo. F-ICG-guided PLND identified LNMs with a Se of 63.4%. CONCLUSIONS: This study confirms that F-ICG-guided lymphangiography correctly staged almost 98% of patients. The high per-patient NPV suggested that avoiding ePLND is safe for most patients when F-ICG stained nodes were pN0. Thus, more conservative approaches might minimise perioperative morbidity during LNMs diagnosis in selected patients.

Impact of the initial experience in the penile inversion vaginoplasty technique on satisfaction levels: a pilot retrospective cohort study.

Background: There is a growing interest in reporting satisfaction levels of transgender women undergoing vaginoplasty surgery. The lack of information regarding satisfaction during the initial experience of the vaginoplasty technique, and the moderate morbidity related to the surgery, could discourage the immersion of new groups in initiating a program of this kind. Therefore, we aim to report patients' level of satisfaction during our initial experience in the penile inversion vaginoplasty technique. Methods: Retrospective study of patients who underwent penile inversion vaginoplasty in our center between September 2019 and August 2021. Surgery technique, demographic data, preoperative clinical variables, and short and long-term follow-up are described. Six months after surgery, a survey elaborated by the research team was conducted by phone. The score goes from 1 to 5, and it evaluates satisfaction on esthetics, functional, psychosocial, and global aspects. Results: Twenty patients underwent penile inversion vaginoplasty in our center during the described period. The average age was 35.6 years old, the mean body mass index (BMI) was 24.7 kg/m2, and they presented low comorbidity. Half of the patients presented at least one complication, most of which were minor. One patient was urgently reoperated due to bleeding, and three patients were reoperated on a scheduled basis from minor surgeries. 90% of the patients answered the questionnaire. The most common answers to all four areas covered (esthetics, functional, psychosocial, and global) were satisfied or very satisfied, resulting in a mean over four points in each one of the sections. Lastly, 94.4% of the patients reported being satisfied with their choice of having undergone surgery. Conclusions: Our initial experience in penile inversion vaginoplasty reveals good satisfaction results at short follow up.

Molecular Biomarkers for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis.

Context: Prostate cancer (PCa) is the second most common type of cancer in men. Individualized risk stratification is crucial to adjust decision-making. A variety of molecular biomarkers have been developed in order to identify patients at risk of clinically significant PCa (csPCa) defined by the most common PCa risk stratification systems. Objective: The present study aims to examine the effectiveness (diagnostic accuracy) of blood or urine-based PCa biomarkers to identify patients at high risk of csPCa. Evidence acquisition: A systematic review of the literature was conducted. Medline and EMBASE were searched from inception to March 2021. Randomized or nonrandomized clinical trials, and cohort and case-control studies were eligible for inclusion. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Pooled estimates of sensitivity, specificity, and area under the curve were obtained. Evidence synthesis: Sixty-five studies (N = 34 287) were included. Not all studies included prostate-specific antigen-selected patients. The pooled data showed that the Prostate Health Index (PHI), with any cutoff point between 15 and 30, had sensitivity of 0.95-1.00 and specificity of 0.14-0.33 for csPCa detection. The pooled estimates for SelectMDx test sensitivity and specificity were 0.84 and 0.49, respectively. Conclusions: The PHI test has a high diagnostic accuracy rate for csPCa detection, and its incorporation in the diagnostic process could reduce unnecessary biopsies. However, there is a lack of evidence on patient-important outcomes and thus more research is needed. Patient summary: It has been possible to verify that the application of biomarkers could help detect prostate cancer (PCa) patients with a higher risk of poorer evolution. The Prostate Health Index shows an ability to identify 95-100 for every 100 patients suffering from clinically significant PCa who take the test, preventing unnecessary biopsies in 14-33% of men without PCa or insignificant PCa.

Prognostic Impact of Sarcopenia in Patients with Advanced Prostate Carcinoma: A Systematic Review.

Prostate cancer (PCa) is the second most common cancer in men and the fifth leading cause of death from cancer. The possibility of sarcopenia being a prognostic factor in advanced PCa patients has recently become a subject of interest. The aim of the present study was to evaluate the prognostic value of sarcopenia in advanced prostate carcinoma. A systematic review was conducted in Medline, EMBASE, and Web of Science (March, 2021). The quality of studies was assessed using the Quality in Prognosis Studies tool. Meta-analyses for overall, cancer-specific, and progression-free survival were performed. Nine studies (n = 1659) were included. Sarcopenia was borderline associated with a shorter overall survival (HR = 1.20, 95% CI: 1.01, 1.44, P = 0.04, I2 = 43%) but was significantly associated with progression-free survival (HR = 1.61, 95% CI: 1.26, 2.06, P < 0.01; k = 3; n = 588). Available evidence supports sarcopenia as an important prognostic factor of progression-free survival in patients with advanced PCa. However, sarcopenia has a weak association with a shorter overall survival. The evidence on the role of sarcopenia in prostate-cancer-specific survival is insufficient and supports the need for further research. Patient summary: The literature was reviewed to determine whether the loss of muscle mass (sarcopenia) affects the survival in patients with advanced PCa. Patients with advanced PCa and sarcopenia were found to have a shorter progression-free survival (the length of time during and after treatment of a cancer that the patient lives with the disease but it does not get worse), but sarcopenia did not have much influence on the overall survival and cancer-specific survival (the length of time from either the date of diagnosis or the start of treatment to the date of death due to the cancer).

Horseshoe kidney splitting technique for transplantation.

Shortage of donors has led to an expansion of the criteria for acceptability of deceased-donor organs including the use of kidneys with anatomical variations such us horseshoe kidneys (HSKs). Transplantation can be accomplished either en bloc or after division of the HSK. Little is known about the most appropriate technique to split the kidney and minimize risk of bleeding or urinary fistula. In this report we present two renal transplants after division of a HSK with a different splitting technique.