Perioperative management of direct oral anticoagulants in patients undergoing radical prostatectomy: results of a prospective assessment.

INTRODUCTION AND OBJECTIVES: In the perioperative setting, temporary interruption of direct oral anticoagulants (DOACs) is recommended. However, the safety of these recommendations is based on non-urological surgical experiences. Our objective was to verify the safety of these recommendations in patients undergoing radical prostatectomy (RP). MATERIALS AND METHODS: Patients regularly receiving a DOAC and scheduled for RP at our institution were prospectively assessed. DOAC intake was usually stopped 48 h before surgery without any preoperative bridging therapy. Postoperatively, patients received risk-adapted low-molecular weight heparin (LMWH). On the third day after unremarkable RP, DOAC intake was restarted and the administration of LMWH was stopped. We assessed perioperative outcomes and 30-day morbidity. RESULTS: Thirty-two consecutive patients receiving DOAC underwent RP at our institution between 12/2017 and 07/2018. Time of surgery (median, 177 min) and intraoperative blood loss (median, 500 mL) were unremarkable. DOACs were restarted on the third postoperative day in 30 patients (94%). No patient had a significant hemoglobin level reduction after DOAC restart. Overall, 28% of patients experienced complications within 30 days after surgery. Most of which were minor (Clavien ≤ 2), three patients (9%), however, had Clavien ≥ 3 complications. CONCLUSION: Our report is the first to prospectively assess current guideline recommendations regarding DOAC restarting after major urological surgery. RP can safely be performed, if DOACs are correctly paused before surgery. Moreover, in case of an uneventful postoperative clinical course, DOACs can be safely restarted on the third postoperative day. A 9% Clavien ≥ 3 30-day morbidity warrants attention and should be further explored in future studies.

Validation of the current eligibility criteria for focal therapy in men with localized prostate cancer and the role of MRI.

PURPOSE: To validate current eligibility criteria for focal therapy (FT) in prostate cancer men undergoing radical prostatectomy (RP) and to assess the role of magnetic resonance imaging (MRI). METHODS: Retrospective analysis of 217 RP patients (2009-2016) with preoperative MRI (almost all in external institutions) and fulfillment of different FT eligibility criteria: unilateral tumor, clinical tumor stage ≤ cT2a, prostate volume ≤ 60 mL and either biopsy Gleason 3 + 3 or ≤ 3 + 4 and PSA ≤ 10 or ≤ 15 ng/mL. Multivariable logistic regression analyses (MVA) assessed the role of MRI to predict the presence of significant contralateral tumor or extracapsular extension (ECE), including seminal vesicle invasion. To quantify model accuracy, Receiver Operating Characteristics-derived area under the curve (AUC) was used. RESULTS: Of 217 patients fulfilling widest biopsy criteria and 113 fulfilling additional MRI criteria, 64 (29.7%) and 37 (32.7%) remained eligible for FT according to histopathological results. In MVA, fulfillment of MRI criteria reached independent predictor status for prediction of contralateral tumor but not for ECE. Addition of MRI resulted in AUC gain (57.5-64.6%). Sensitivity, specificity, PPV and NPV for MRI to predict contralateral tumor were: 41.8, 71.6, 70.9 and 42.6%, respectively. Virtually the same results were recorded for Gleason 3 + 3 and/or PSA ≤ 10 ng/mL. CONCLUSIONS: Patient eligibility criteria for FT using biopsy criteria remained insufficient with respect to contralateral tumor disease. Although, MRI improves accuracy, it cannot safely exclude or minimize chance of significant cancer on contralateral prostate side. To date, stricter eligibility criteria are needed to provide more diagnostic reliability.

The Role of Pelvic Lymph Node Dissection During Radical Prostatectomy in Patients With Gleason 6 Intermediate-risk Prostate Cancer.

OBJECTIVE: To analyze the benefit of pelvic lymph node dissection (PLND) in patients with biopsy Gleason grade ≤ 6, cT ≤ 2b, and prostate-specific antigen (PSA) 10-20 ng/mL (main study cohort), as the indication for PLND during radical prostatectomy remains uncertain in patients with nonhigh-risk tumors. MATERIALS AND METHODS: The main study cohort included 1383 patients with low intermediate-risk cancer undergoing radical prostatectomy with or without PLND between 1994 and 2013. Positive lymph node (LN) rates were reported and compared to patients with higher (≥20 ng/mL; n = 314) and lower (<10 ng/mL; n = 6861) PSA. Oncological outcome was assessed by Cox regressions in patients with a minimum follow-up of 5years. RESULTS: In the main study cohort (PSA 10-20 ng/mL), PLND was performed in 867 (62.7%) patients with a median number of removed LNs of 11 (interquartile range 16-6). Positive LNs were detected in 3.3% of these patients. Compared to the main study cohort, patients with preoperatively higher PSA ≥ 20 ng/mL (or lower PSA < 10 ng/ml) underwent PLND in 83.8% (32.7%) of the cases, with 8.0% (1.8%) showing positive LNs. Median follow-up in the main study cohort was 84.5 months. Biochemical recurrence (BCR) occurred in 20.6% of these men. The 5-year and 10-year BCR-free survival rates were 82.2% and 75.6% for those with PLND, and 83.4% and 75.8% for patients without PLND. PLND was not a significant factor influencing BCR-free, metastasis-free, or cancer-specific survival in the main study cohort. CONCLUSION: Positive LNs are rare in patients with Gleason grade ≤ 6, cT ≤ 2b, and PSA 10-20 ng/mL. Performing PLND had no statistical influence on oncologic outcome and therefore should be decided upon on an individual basis.

Oncological, functional and perioperative outcomes in transplant patients after radical prostatectomy.

PURPOSE: Oncological surgery in immunosuppressed patients with solid organ transplantation (Tx) is challenging. These patients are thought to have higher postoperative morbidity and an increased rate of tumour progression. The aim of the present study was to analyse oncological, functional and perioperative outcomes in Tx patients following radical prostatectomy (RP). MATERIALS AND METHODS: Between 1996 and 2014, 30 patients diagnosed with prostate cancer underwent RP at our institution following Tx (kidney: n = 20, heart: n = 5, liver: n = 5). Functional, oncological and perioperative follow-ups were analysed. Postoperative complications were assessed using the Clavien-Dindo classification. RESULTS: Median follow-up was 45 months. Median PSA was 5.3 ng/ml. Intraoperative blood loss was 600 ml at a median operating time of 180 min. Surgery in kidney Tx patients was technically feasible. Major complications occurred in 3 patients (ureteral injury, lymphocele and haematoma). Histological evaluation revealed n = 18 ≤pT2 tumours (60.0 %), n = 7 pT3a tumours (23.3 %) and n = 5 ≥pT3b tumours (16.7 %). Continence rate 12 months after surgery, defined as no or one safety pad use, was 73.3 %, while 93.3 % of the patients used ≤2 pads/24 h. After the median follow-up of 45 months, BCR-free survival was 69.0 %. In recurrent men, there was suspicion of metastasis in one patient. No cancer-specific death was observed. Five-year overall survival was 94.4 %. CONCLUSION: The complication rate in patients with solid organ transplantation after RP was low. While histopathological evaluation revealed disease characteristics comparable to non-transplant patients from current RP series, postoperative continence was worse. Immunosuppressive therapy does not seem to lead to an increased rate of tumour progression.