Circulating Tumor DNA Assay Detects Merkel Cell Carcinoma Recurrence, Disease Progression, and Minimal Residual Disease: Surveillance and Prognostic Implications.

PURPOSE: Merkel cell carcinoma (MCC) is an aggressive skin cancer with a 40% recurrence rate, lacking effective prognostic biomarkers and surveillance methods. This prospective, multicenter, observational study aimed to evaluate circulating tumor DNA (ctDNA) as a biomarker for detecting MCC recurrence. METHODS: Plasma samples, clinical data, and imaging results were collected from 319 patients. A tumor-informed ctDNA assay was used for analysis. Patients were divided into discovery (167 patients) and validation (152 patients) cohorts. Diagnostic performance, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), was assessed. RESULTS: ctDNA showed high sensitivity, 95% (discovery; 95% CI, 87 to 99) and 94% (validation; 95% CI, 85 to 98), for detecting disease at enrollment, with corresponding specificities of 90% (95% CI, 82 to 95) and 86% (95% CI, 77 to 93). A positive ctDNA during surveillance indicated increased recurrence risk, with hazard ratios (HRs) of 6.8 (discovery; 95% CI, 2.9 to 16) and 20 (validation; 95% CI, 8.3 to 50). The PPV for clinical recurrence at 1 year after a positive ctDNA test was 69% (discovery; 95% CI, 32 to 91) and 94% (validation; 95% CI, 71 to 100), respectively. The NPV at 135 days after a negative ctDNA test was 94% (discovery; 95% CI, 90 to 97) and 93% (validation; 95% CI, 89 to 97), respectively. Patients positive for ctDNA within 4 months after treatment had higher rates of recurrence, with 1-year rates of 74% versus 21% (adjusted HR, 7.4 [95% CI, 2.7 to 20]). CONCLUSION: ctDNA testing exhibited high prognostic accuracy in detecting MCC recurrence, suggesting its potential to reduce frequent surveillance imaging. ctDNA also identifies high-risk patients who need more frequent imaging and may be best suited for adjuvant therapy trials.

Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study.

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

THE IMPACT OF ROUTINE CARDIAC TROPONIN I-BASED CARDIOTOXICITY SCREENING ON CLINICAL OUTCOMES IN PATIENTS ON CANCER IMMUNOTHERAPY.

Purpose: Immune checkpoint inhibitors (ICI) used as cancer therapy have been associated with a range of cardiac immune-related adverse events (irAEs), including fulminant myocarditis with a high case fatality rate. Early detection through cardiotoxicity screening by biomarker monitoring can lead to prompt intervention and improved patient outcomes. In this study, we investigate the association between cardiotoxicity screening with routine serial troponin I monitoring in asymptomatic patients receiving ICI, cardiovascular adverse event (CV AE) detection, and overall survival (OS). Methods: We instituted a standardized troponin I screening protocol at baseline and with each ICI dose (every 2-4 weeks) in all patients receiving ICI at our center starting Jan 2019. We subsequently collected data in 825 patients receiving ICI at our institution from January 2018 to October 2021. Of these patients, 428 underwent cardiotoxicity screening with serial troponin I monitoring during ICI administration (Jan 2019-Oct 2021) and 397 patients were unmonitored (Jan 2018-Dec 2018). We followed patients for nine months following their first dose of ICI and compared outcomes of CV AEs and OS between monitored and unmonitored patients. Additionally, we investigated rates of CV AEs, all-cause mortality, and oncologic time-to-treatment failure (TTF) between patients with an elevated troponin I value during the monitoring period versus patients without elevated troponin I. Results: We found a lower rate of severe (grades 4-5) CV AEs, resulting in critical illness or death, in patients who underwent troponin monitoring (0.5%) compared to patients who did not undergo monitoring (1.8%), (HR 0.17, 95% CI 0.02-0.79, p = 0.04). There was no difference in overall CV AEs (grades 3-5) or OS between monitored and unmonitored patients. In the entire cohort, patients with at least one elevated troponin I during the follow up period, during routine monitoring or unmonitored, had a higher risk of overall CV AEs (HR 10.96, 95% CI 4.65-25.85, p<0.001) as well as overall mortality (HR 2.67, 95% CI 1.69 - 4.10, p<0.001) compared to those without elevated troponin. Oncologic time-to-treatment failure (TTF) was not significantly different in a sub-cohort of monitored vs. unmonitored patients. Conclusions: Patients undergoing cardiotoxicity screening with troponin I monitoring during ICI therapy had a lower rate of severe (grade 4-5) CV AEs compared patients who were not screened. Troponin I elevation in screened and unscreened patients was significantly associated with increased CV AEs as well as increased mortality. Troponin I monitoring did not impact oncologic time-to-treatment-failure in a sub-cohort analysis of patients treated with ICI. These results provide preliminary evidence for clinical utility of cardiotoxicity screening with troponin I monitoring in patients receiving ICI therapy.

Oncologic outcomes with and without amniotic membranes in robotic-assisted radical prostatectomy: A propensity score matched analysis.

Objective: Placement of human placenta derived grafts during robotic-assisted radical prostatectomy (RARP) hastens the return of continence and potency. The long-term impact on the oncologic outcomes remains to be investigated. Our objective was to determine the oncologic outcomes of patients with dehydrated human amnion chorion membrane (dHACM) at RARP compared to a matched cohort. Methods: In a referral centre, from August 2013 to October 2019, 599 patients used dHACM in bilateral nerve-sparing RARP. We excluded patients with less than 12 months follow-up, simple prostatectomy, and unilateral nerve-sparing. Patients with dHACM (amnio group) were 529, and were propensity score matched 1:1 to 2465 patients without dHACM (non-amnio group) and a minimum follow-up of 36 months. At the time of RARP, dHACM was placed around the neurovascular bundle in the amnio group. Continuous and categorical variables in matched groups was tested by two-sample Kolmogorov-Smirnov test and Fisher's exact test respectively. Outcomes measured were biochemical recurrence (BCR), adjuvant and salvage therapy rates. Results: Propensity score matching resulted in two groups of 444 patients. Cumulative incidence functions for BCR did not show a difference between the groups (p=0.3). Patients in the non-amnio group required salvage therapy more frequently than the amnio group, particularly after partial nerve-sparing RARP (6.3% vs. 2.3%, p=0.001). Limitations are the absence of prospective randomization. Conclusion: The data suggest that using dHACM does not have a negative impact on BCR in patients. Outcomes of cancer specific and overall survival will require follow-up study to increase our understanding of these grafts' impact on prostate cancer biology.

Impact of human placental derivative allografts on functional and oncological outcomes after radical prostatectomy: a literature review.

Post radical prostatectomy (RP) erectile dysfunction and incontinence impacts quality of life for patients. In an objective to hasten the recovery of these functional outcomes, human placental derived allografts laid on neurovascular bundles (NVB) have been investigated. These grafts include amniotic membranes (AM) chorionic membranes (CM) or umbilical cord (UC) allografts. A literature review performed using the MeSH terms "AMNION" OR "CHORION" OR "AMNIOTIC MEMBRANE" OR "UMBILICAL CORD" AND "PROSTATE CANCER" from no specified start date, to April 2022. 163 articles were retrieved, with 149 articles excluded. 14 articles were eligible and analysed. 5 articles were included in this review for an analysis on comparative outcomes. The average return to potency was statistically significant in the intervention groups. Positive surgical margin (PSM) rates showed a higher rate in the control groups. BCR was observed at a lower rate in the interventional group. This review reveals a benefit from human placental allograft's ability to hasten post RP functional recovery, without impacting oncological control.

Health Care Utilization and Costs in Systemic Therapies for Metastatic Melanoma from 2016 to 2020.

BACKGROUND: Widespread implementation of immune checkpoint inhibitors (ICI) and targeted therapies for metastatic melanoma has led to a decline in melanoma-related mortality but increased healthcare costs. We aimed to determine how healthcare utilization varied by systemic, non-adjuvant melanoma treatment from 2016 to 2020. PATIENTS AND METHODS: Adults with presumed stage IV metastatic melanoma receiving systemic therapy from 2016 to 2020 were identified in Optum, a nationwide commercial claims database. Treatment groups were nivolumab, pembrolizumab, ipilimumab+nivolumab (combination-ICI), or BRAF+MEK inhibitor (BRAFi+MEKi) therapy. Outcomes included hospitalizations, days hospitalized, emergency room (ER) visits, outpatient visits, and healthcare costs per patient per month (pppm). Multivariable regression models were used to analyze whether cost and utilization outcomes varied by treatment group, with nivolumab as reference. RESULTS: Among 2018 adult patients with metastatic melanoma identified, mean (SD) age was 67 (15) years. From 2016 to 2020, nivolumab surpassed pembrolizumab as the most prescribed systemic melanoma therapy while combination-ICI and BRAFi+MEKi therapies remained stable. Relative to nivolumab, all other therapies were associated with increased total healthcare costs (combination-ICI: ß = $47 600 pppm, 95%CI $42 200-$53 100; BRAFi+MEKi: ß = $3810, 95%CI $365-$7260; pembrolizumab: ß = $6450, 95%CI $4420-$8480). Combination-ICI and BRAFi+MEKi therapies were associated with more inpatient hospital days. CONCLUSIONS: Amid the evolving landscape of systemic therapy for advanced melanoma, nivolumab monotherapy emerged as the most used and least costly systemic treatment from 2016 to 2020. Its sharp increase in use in 2018 and lower costs relative to pembrolizumab may in part be due to earlier adoption of less frequent dosing intervals.

Intracranial Control With Combination BRAF and MEK Inhibitor Therapy in Patients With Metastatic Melanoma.

Purpose/Objectives Combination BRAF (vemurafenib, dabrafenib, or encorafenib) plus MEK (trametinib, cobimetinib, or binimetinib) inhibitor therapy is now widely used in the treatment of metastatic melanoma. However, data for intracranial response to these drugs are limited. We aimed to evaluate the intracranial efficacy of BRAF plus MEK inhibitors in patients with BRAF-mutant melanoma with brain metastases (BM) and to determine patterns of failure of these new agents to inform optimal integration of local intracranial therapy. Materials and methods We retrospectively reviewed charts of patients with BRAF-mutant melanoma with metastasis to the brain with at least one untreated brain metastasis at the time of initiation of BRAF plus MEK inhibitors at our institution from 2006 to 2020. We collected per-patient and per-lesion data on demographics, treatment modality, and outcomes. The cumulative incidence of local (LF), distant intracranial (DF), and extracranial failure (EF) were calculated with competing risk analysis with death as a competing risk and censored at the last brain MRI follow-up. LF was calculated on a per-lesion basis while DF and EF were calculated on a per-patient basis. DF was defined as any new intracranial lesions. Overall survival (OS) was analyzed using Kaplan-Meier. Logistic regression was used to identify predictors for LF. Results We identified 10 patients with 63 untreated brain metastases. The median age was 50.5 years. The median sum of the diameters of the five largest untreated brain metastases per patient was 20 mm (interquartile range 15-39 mm) and the median diameter for all measurable lesions was 4 mm. Median follow-up time was 9.0 months (range 1.4 months-46.2 months). Median OS was 13.6 months. The one-year cumulative incidence of LF, DF, and EF was 17.1%, 88.6, and 71.4%, respectively. The median time to LF, DF, and EF from the start of BRAF plus MEK inhibitors was 9.0 months, 4.7 months, and 7.0 months, respectively. The larger size of the BM was associated with LF on univariate analysis (odds ratio 1.13 per 1 mm increase in diameter, 95% confidence interval 1.019 to 1.308, p<0.02). Two (20%) patients eventually received stereotactic radiosurgery, and 2 (20%) received whole-brain radiotherapy for intracranial progression. Conclusion Although patients with BRAF-mutant melanoma with BM had fair local control on BRAF plus MEK inhibitors, the competing risk of death and distant intracranial and extracranial progression was high. Patients with larger brain metastases may benefit from local therapy.

Mycobacterium kansasaii and Mycobacterium scrofulaceum dual pulmonary infection in an immunocompetent male: first report from India.

A 57-year-old farmer presented with chronic cough and recurrent hemoptysis, previously treated for sputum positive pulmonary tuberculosis. Referred to us for evaluation of drug resistant tuberculosis as his sputum was persistently positive for acid fast bacilli along with radiological worsening even after 6 months of antitubercular treatment. Bronchoalveolar lavage was done and he was diagnosed with a rare mixed non-tuberculous mycobacyteria (NTM) pulmonary infection despite no immune dysfunction. He was successfully treated with multidrug regimen of rifampicin, isoniazid, ethambutol and clarithromycin.

Identification of Pathogenic Immune Cell Subsets Associated With Checkpoint Inhibitor-Induced Myocarditis.

BACKGROUND: Immune checkpoint inhibitors (ICIs) are monoclonal antibodies used to activate the immune system against tumor cells. Despite therapeutic benefits, ICIs have the potential to cause immune-related adverse events such as myocarditis, a rare but serious side effect with up to 50% mortality in affected patients. Histologically, patients with ICI myocarditis have lymphocytic infiltrates in the heart, implicating T cell-mediated mechanisms. However, the precise pathological immune subsets and molecular changes in ICI myocarditis are unknown. METHODS: To identify immune subset(s) associated with ICI myocarditis, we performed time-of-flight mass cytometry on peripheral blood mononuclear cells from 52 individuals: 29 patients with autoimmune adverse events (immune-related adverse events) on ICI, including 8 patients with ICI myocarditis, and 23 healthy control subjects. We also used multiomics single-cell technology to immunophenotype 30 patients/control subjects using single-cell RNA sequencing, single-cell T-cell receptor sequencing, and cellular indexing of transcriptomes and epitopes by sequencing with feature barcoding for surface marker expression confirmation. To correlate between the blood and the heart, we performed single-cell RNA sequencing/T-cell receptor sequencing/cellular indexing of transcriptomes and epitopes by sequencing on MRL/Pdcd1-/- (Murphy Roths large/programmed death-1-deficient) mice with spontaneous myocarditis. RESULTS: Using these complementary approaches, we found an expansion of cytotoxic CD8+ T effector cells re-expressing CD45RA (Temra CD8+ cells) in patients with ICI myocarditis compared with control subjects. T-cell receptor sequencing demonstrated that these CD8+ Temra cells were clonally expanded in patients with myocarditis compared with control subjects. Transcriptomic analysis of these Temra CD8+ clones confirmed a highly activated and cytotoxic phenotype. Longitudinal study demonstrated progression of these Temra CD8+ cells into an exhausted phenotype 2 months after treatment with glucocorticoids. Differential expression analysis demonstrated elevated expression levels of proinflammatory chemokines (CCL5/CCL4/CCL4L2) in the clonally expanded Temra CD8+ cells, and ligand receptor analysis demonstrated their interactions with innate immune cells, including monocytes/macrophages, dendritic cells, and neutrophils, as well as the absence of key anti-inflammatory signals. To complement the human study, we performed single-cell RNA sequencing/T-cell receptor sequencing/cellular indexing of transcriptomes and epitopes by sequencing in Pdcd1-/- mice with spontaneous myocarditis and found analogous expansions of cytotoxic clonal effector CD8+ cells in both blood and hearts of such mice compared with controls. CONCLUSIONS: Clonal cytotoxic Temra CD8+ cells are significantly increased in the blood of patients with ICI myocarditis, corresponding to an analogous increase in effector cytotoxic CD8+ cells in the blood/hearts of Pdcd1-/- mice with myocarditis. These expanded effector CD8+ cells have unique transcriptional changes, including upregulation of chemokines CCL5/CCL4/CCL4L2, which may serve as attractive diagnostic/therapeutic targets for reducing life-threatening cardiac immune-related adverse events in ICI-treated patients with cancer.

Knowledge, Attitude and Practices among Gynecologists Regarding Oral Health of Expectant Mothers of South Bengaluru, Karnataka.

Background: To evaluate the knowledge perspective and trainings among gynecologists' considering oral health of pregnant mothers of South Bengaluru city, by questionnaire. Materials and methods: A total of 60 gynecologists are included in the study. Prior to the study, the questionnaire was pretested by Pedodontist. The questionnaire was administered on the first day of visit, and on the next day it was collected back. Results: The research unveiled that a greater number of gynecologists had satisfactory knowledge attitude and training concerning oral health of expectant mothers. Conclusion: The predominance of gynecologists has satisfying knowledge perspective as well as practices, but still there is a demand for better effective attendance and involvement of medical specialists like gynecologists and pediatricians in continuing the education programs and forums on dentistry. How to cite this article: Popli HP, Kumar VD, Khatib MS, et al. Knowledge, Attitude and Practices among Gynecologists regarding Oral Health of Expectant Mothers of South Bengaluru, Karnataka. Int J Clin Pediatr Dent 2022;15(1):85-89.

Management of Immunotherapy-Related Toxicities, Version 1.2022, NCCN Clinical Practice Guidelines in Oncology.

The aim of the NCCN Guidelines for Management of Immunotherapy-Related Toxicities is to provide guidance on the management of immune-related adverse events resulting from cancer immunotherapy. The NCCN Management of Immunotherapy-Related Toxicities Panel is an interdisciplinary group of representatives from NCCN Member Institutions, consisting of medical and hematologic oncologists with expertise across a wide range of disease sites, and experts from the areas of dermatology, gastroenterology, endocrinology, neurooncology, nephrology, cardio-oncology, ophthalmology, pulmonary medicine, and oncology nursing. The content featured in this issue is an excerpt of the recommendations for managing toxicities related to CAR T-cell therapies and a review of existing evidence. For the full version of the NCCN Guidelines, including recommendations for managing toxicities related to immune checkpoint inhibitors, visit NCCN.org.

Minimally invasive lymphocele drainage using the Da Vinci® single port platform: step-by- step technique

ABSTRACT Background: Reports in the literature describe lymphocele formation in up to half of patients following pelvic lymph node dissection (PLND) (1) in robotic-assisted radical prostatectomy (RARP), with 1-2% requiring intervention (2). The advantage of surgical approach is permanent excision of the lymphocele capsule and fewer days with pelvic drains compared to percutaneous drainage. This study aims to describe the step-by-step surgical management of symptomatic lymphoceles using a less invasive robotic platform, the Da Vinci® Single Port (SP). Material and Methods: We describe the technique of lymphocelectomy and marsupialization with the Da Vinci® SP for symptomatic lymphocele. For this study, several treatment modalities for symptomatic lymphoceles were available, including percutaneous drainage, sclerosing agents, and surgical marsupialization. All the data for this study were obtained through the procedure via Da Vinci® SP. Results: Operative time for the case was 84 minutes. Blood loss was 25ml. No intra- or post- operative complications were reported. The patient had his drain removed in under 24 hours after surgery. The mean follow-up period was 7.7 months. There were no complications or lymphocele recurrence. Conclusion: Da Vinci® SP lymphocelectomy is safe and feasible with satisfactory outcomes. The SP enables definitive treatment of the lymphocele sac (3), reducing the number of days with abdominal drains and allows further decrease in surgical invasiveness with fewer incisions and better cosmesis.

Minimally invasive lymphocele drainage using the Da Vinci® single port platform: step-by- step technique.

BACKGROUND: Reports in the literature describe lymphocele formation in up to half of patients following pelvic lymph node dissection (PLND) (1) in robotic-assisted radical prostatectomy (RARP), with 1-2% requiring intervention (2). The advantage of surgical approach is permanent excision of the lymphocele capsule and fewer days with pelvic drains compared to percutaneous drainage. This study aims to describe the step-by-step surgical management of symptomatic lymphoceles using a less invasive robotic platform, the Da Vinci® Single Port (SP). MATERIAL AND METHODS: We describe the technique of lymphocelectomy and marsupialization with the Da Vinci® SP for symptomatic lymphocele. For this study, several treatment modalities for symptomatic lymphoceles were available, including percutaneous drainage, sclerosing agents, and surgical marsupialization. All the data for this study were obtained through the procedure via Da Vinci® SP. RESULTS: Operative time for the case was 84 minutes. Blood loss was 25ml. No intra- or post- operative complications were reported. The patient had his drain removed in under 24 hours after surgery. The mean follow-up period was 7.7 months. There were no complications or lymphocele recurrence. CONCLUSION: Da Vinci® SP lymphocelectomy is safe and feasible with satisfactory outcomes. The SP enables definitive treatment of the lymphocele sac (3), reducing the number of days with abdominal drains and allows further decrease in surgical invasiveness with fewer incisions and better cosmesis.

Same-Day Discharge Protocol for Robot-Assisted Radical Prostatectomy: Experience of a High-Volume Referral Center.

Objective: As the coronavirus disease 2019 (COVID-19) global pandemic continues, there is increased value in performing same-day discharge (SDD) protocols to minimize viral exposure and maintain the appropriate surgical treatment for oncologic patients. In this scenario, we performed a prospective analysis of outcomes of our patients undergoing SDD protocol after robot-assisted radical prostatectomy (RARP). Materials and Methods: The SDD criteria included patients with no intraoperative complications, stable postoperative hemoglobin levels (compared with preoperative values), stable vital signs, normal urine output, ambulation with assistance and independently without dizziness, tolerance of clear liquids without nausea or vomiting, pain control with oral medication, and patient/family confidence with SDD. Patients older than 70 years, concomitant general surgery operations, multiple comorbidities, and complex procedures such as salvage surgery were excluded from our protocol. Results: Of the 101 patients who met the criteria for SDD, 73 (72%) had an effective SDD. All SDF (same day discharge failure) patients were discharged one day after surgery. Intraoperative characteristics were not statistically different with a median operative time of 92 (81-107) vs 103 (91-111) minutes for SDD and SDF, respectively. Of the 28 SDF patients, the most common reasons for staying were anesthesia-related factors of nausea (35%), drowsiness (7%), patient/caregiver preference (25%), pain (14%), labile blood pressure (7%), arrhythmia (7%), and dizziness (7%). There was no significant difference in readmission rates, complication rates, or postoperative pain scores between SDD and SDF patients. Conclusions: In our experience, SDD for patients undergoing RARP can be safely and feasibly incorporated into a clinical care pathway without increasing readmission rates. We were effective in 72% of cases because of coordinated care between anesthetics, nursing staff, and appropriate patient selection. We also believe that incorporating pre- and postoperative patient education and assurance is crucial to minimize their exposure to COVID-19 during the surgical treatment for prostate cancer.

Nerve spare robot assisted laparoscopic prostatectomy with amniotic membranes: medium term outcomes.

INTRODUCTION: dHACM is a source of factors including cytokines that allow anti-inflammatory and proliferative elements to be utilized for wound and ulcer management. We present our experience of using dHACM in a cohort of patients undergoing nerve-sparing (NS) robot-assisted laparoscopic prostatectomy (RALP). Our objective is to investigate the functional and oncological outcomes of NS after placing amniotic or dehydrated human amnion/chorion membrane (dHACM) on preserved neurovascular bundles (NVBs). From 2013 to 2019, our institution performed transperitoneal multi-port da Vinci robotic prostatectomy. The NVBs are spared by releasing their fascial planes posteriorly, followed by an anterior release of the plane at a similar level. Once the retrograde release of the NVB is performed then 599 patients underwent placement of dHACM graft (AmnioFix by MiMedx, Marietta, GA, USA). The graft was cut into two 4 × 1 cm pieces and laid over the NVB as a wrap. In order to inform the urological community of oncological and functional outcomes, we excluded patients with less than 12 months follow up (n = 64), benign prostatic hyperplasia (n = 5), and unilateral NS (n = 1). 529 (88%) patients were included in this study who underwent a partial or full bilateral NS with dHACM. 529 patients were followed-up for a median (IQR) of 42 months (25-89). Demographics include median (IQR) age 57 years (52-62), median preoperative SHIM score of 24 (21-15), and AUASS of 5 (2-11). Full NS was performed in 74% (391/529). Pathological staging was pT2 = 399 (75%), pT3a = 107 (20%), pT3b = 19 (4%) and pT4 = 4 (1%) with N1 = 3 (0.6%). The number of patients with PSM was 86 (16%), and the overall BCR in the entire cohort was 10%. Postoperatively, 434 (82%) were sexually active. Median time to potency was 119 (37-420) days and time to continence was 42 (23-91) days. Regarding full vs partial NS: median post op SHIM score 18 (13-20) vs 15 (6-20), median time to potency 92 (35-365) days vs 184 (42-560) days, and median time to continence 42 (23-91) days vs 44 (30-92) days. Age > 55 vs ≤ 55 years: median post op SHIM score 18 (12-20) vs 15 (10-20), median time to potency 167 days (42-549) vs 80 (35-288) days, and median time to continence 42 (25-116) days vs 42 (29-76) days. In our series the application of amniotic membrane/dHACM has led to acceptable post RALP outcomes. The BCR rate of 10% in addition to the recovery of potency at a median time of 3 months and continence at 6 weeks is an encouraging result of dHACM. Our findings indicate that dHACM allowed for an even faster period for continence recovery which was independent of grade of NS. Future comparative studies may further assess the impact of new amniotic membrane types on the functional and oncological outcomes after RALP.