Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Predicting factor analysis of postoperative complications after robot-assisted radical cystectomy: Multicenter KORARC database study.

OBJECTIVES: To evaluate postoperative complications following robot-assisted radical cystectomy in patients diagnosed with bladder cancer and reveal if there are predictors for postoperative complications. METHODS: Prospectively collected medical records of 730 robot-assisted radical cystectomy patients between 2007/04 and 2019/05 in 13 tertiary referral centers were reviewed. Perioperative outcomes were compared between two groups by postoperative complications (complication vs non-complication). We assessed recurrence-free survival, cancer-specific survival, and overall survival between groups. Regression analyses were implemented to identify factors associated with postoperative complications. RESULTS: Any total and high-grade complication (Clavien-Dindo grade ≥3) rates were 57.8% and 21.1%, respectively. Patients in complication group had significantly higher proportion of diabetes mellitus (P = 0.048), chronic kidney disease (P = 0.011), dyslipidemia (P < 0.001), longer operation time (P = 0.001), more estimated blood loss (P = 0.001), and larger intraoperative fluid volume (P < 0.001). There was a significant difference in cancer-specific survival (log-rank P = 0.038, median cancer-specific survival: both groups not reached). Dyslipidemia (odds ratio 2.59, P = 0.002) and intraoperative fluid volume (odds ratio 1.0002, P = 0.040) were significantly associated with high-grade postoperative complications. Diabetes mellitus (odds ratio 1.97, P = 0.028), chronic kidney disease (odds ratio 1.89, P = 0.046), dyslipidemia (odds ratio 5.94, P = 0.007), and intraoperative fluid volume (odds ratio 1.0002, P = 0.009) were significantly associated with any postoperative complications. CONCLUSIONS: Patients with diabetes mellitus, chronic kidney disease, dyslipidemia, or a relatively large intraoperatively infused fluid volume are more likely to develop postoperative complications. Patients with postoperative complications might have a possibility of lower cancer-specific survival rate.

Oncological outcome according to attainment of pentafecta after robot-assisted radical cystectomy in patients with bladder cancer included in the multicentre KORARC database.

OBJECTIVES: To investigate the oncological significance of a robot-assisted radical cystectomy (RARC)-related pentafecta in patients with bladder cancer. PATIENTS AND METHODS: Using the KORARC database, which includes data from 12 centres, data from 730 patients who underwent RARC between April 2007 and May 2019 were prospectively collected and retrospectively analysed. Pentafecta was achieved if patients met all of the following criteria: (i) negative soft tissue surgical margin; (ii) ≥16 lymph nodes removed; (iii) no major complications (Clavien-Dindo grade 3-5) within 90 days; (iv) no clinical recurrence within the first 12 months; and (v) no ureteroenteric stricture. Patients were divided into two groups according to pentafecta attainment, and a comparison of overall survival (OS) and cancer-specific survival (CSS) using multivariate Cox proportional analysis was then carried out. RESULTS: Of the 730 patients included in this analysis, 208 (28.5%) attained the RARC pentafecta; the remaining 522 (71.5%) did not. The mean age of the patients was 64.67 years, 85.1% were men, 53.6% received a conduit, 37.7% received orthotopic neobladders and the total complication rate was 57.8%. Those who attained the pentafecta received more neobladders (P = 0.039), were more likely to be treated with the intracorporeal technique (P < 0.001), had longer operating times (P = 0.020) and had longer console time (P = 0.021) compared with those who did not attain the pentafecta. Over a mean of 31.1 months of follow-up, the pentafecta attainment group had significantly higher OS and CSS rates compared with the non-attainment group (10-year OS 70.4% vs 58.1%, respectively [P = 0.016]; 10-year CSS 87.8% vs 70.0%, respectively [P = 0.036]). Multivariate analysis showed that the RARC pentafecta was a significant predictor of overall mortality (hazard ratio 0.561; P = 0.038). CONCLUSIONS: Patients who attained the RARC pentafecta had significantly better survival outcomes compared with those who did not. These criteria could be used to standardize assessment of the surgical quality of RARC. In the future, a similar study using an independent cohort is warranted to confirm our results.

Robot-assisted partial nephrectomy for high-complexity tumors (PADUA score ≥10): Perioperative, long-term functional and oncologic outcomes.

OBJECTIVES: To evaluate the safety and efficacy, and long-term functional and oncologic outcomes of robot-assisted partial nephrectomy in high-complexity tumors. METHODS: Data of 155 patients with a high-complexity tumor (PADUA score ≥10) were reviewed. Trifecta achievement, intra-, perioperative, functional, and oncologic outcomes were analyzed and compared between patients with increasing complexity. RESULTS: Of the 155 patients, 65 (41.9%) patients had a PADUA score of 10, 55 (35.5%) had a PADUA score of 11, and 35 (22.6%) had a PADUA score of 12-13, respectively. The median (interquartile range) operative time, warm ischemia time and estimated blood loss were 150 min (112-186 min), 26 min (23-32 min) and 250 mL (100-500 mL), respectively. Postoperatively, complications occurred in 25 (16.1%) patients, and positive surgical margins in 15 (10.5%) patients. Trifecta was achieved in 67 (43.2%) patients. At a median follow-up period of 58 months, the median estimated glomerular filtration rate preservation was 87% (78-110), and 12 (7.7%) patients developed new-onset chronic kidney disease. Recurrence-free survival and overall survival rates were 93.6% and 96.7%, respectively. Positive surgical margins were statistically different between the groups of PADUA score 10, 11 and 12-13 (P = 0.017), whereas functional and oncologic outcomes were similar. In multivariate logistic regression analysis, increasing tumor size (odds ratio 1.48, 95% confidence interval 1.21-1.87; P < 0.001) and the American Society of Anesthesiologists score 2/3 (odds ratio 0.48, 95% confidence interval 0.24-0.96; P = 0.041) were independent predictors of trifecta failure. CONCLUSIONS: Robot-assisted partial nephrectomy is a safe and effective treatment for high-complexity tumors providing excellent long-term functional and oncologic outcomes.

Retzius Sparing Robot-Assisted Radical Prostatectomy Conveys Early Regain of Continence over Conventional Robot-Assisted Radical Prostatectomy: A Propensity Score Matched Analysis of 1,863 Patients.

PURPOSE: We compared early continence recovery after surgical treatment of prostate cancer with Retzius sparing robot-assisted radical prostatectomy and conventional robot-assisted radical prostatectomy. MATERIALS AND METHODS: Robot-assisted radical prostatectomy was done by a single surgeon in 1,863 cases between October 2005 and May 2018 using the conventional and the Retzius sparing technique in 1,150 and 713, respectively. To compare continence outcomes between the groups propensity score matching was performed using 9 preoperative variables, including age, body mass index, prostate specific antigen, biopsy Gleason Grade Group, clinical T stage, prostate volume on transrectal ultrasound, and the I-PSS (International Prostate Symptom Score), I-PSS quality of life score and International Index of Erectile Function-5 scores. Continence was assessed by the pad count every month postoperatively until month 6 and was converted to a binary outcome. RESULTS: After propensity score matching 609 cases per group were matched with no significant difference in all 9 variables. The Kaplan-Meier curve analysis revealed that Retzius sparing robot-assisted radical prostatectomy was associated with a significantly better continence recovery rate than conventional robot-assisted radical prostatectomy during the 6-month study period (p <0.001). CONCLUSIONS: Based on propensity score matching with multiple variables and a large case series, Retzius sparing robot-assisted radical prostatectomy can be a candidate for future robot-assisted radical prostatectomy. It achieves better early continence recovery, a short operative time and early recovery compared to conventional robot-assisted radical prostatectomy.

Neoadjuvant Chemotherapy is Not Associated with Adverse Perioperative Outcomes after Robot-Assisted Radical Cystectomy: A Case for Increased Use from the IRCC.

PURPOSE: We sought to determine the trend of neoadjuvant chemotherapy use for nonmetastatic muscle invasive urothelial bladder cancer and whether it is associated with adverse perioperative morbidity after robot-assisted radical cystectomy. MATERIALS AND METHODS: We retrospectively reviewed the IRCC (International Robotic Cystectomy Consortium) database between 2006 and 2017. After excluding patients with nonmuscle invasive bladder cancer the patients were divided into 2 groups, including those who did vs did not receive neoadjuvant chemotherapy. Data were reviewed for demographics, preoperative, operative and 90-day perioperative outcomes. We used the Cochran-Armitage trend test to assess trends of neoadjuvant chemotherapy associations with high grade and overall complications with time. Multivariate stepwise regression analyses were done to determine whether neoadjuvant chemotherapy was associated with prolonged operative time, 90-day postoperative complications, readmissions, reoperations and mortality after robot-assisted radical cystectomy. RESULTS: A total of 298 patients (26%) received neoadjuvant chemotherapy. These patients were younger (age 67 vs 69 years, p=0.01) and more frequently had an ASA™ (American Society of Anesthesiologists™) score of 3 or greater (62% vs 55%, p=0.02) and pathological T3 stage or greater disease (28% vs 22%, p=0.04). The use of neoadjuvant chemotherapy increased significantly from 10% in 2006 to 2007 to 42% in 2016 to 2017 (p <0.01). On multivariate analysis neoadjuvant chemotherapy was not significantly associated with prolonged operative time, hospital stay, 90-day postoperative complications, reoperation or mortality. Neoadjuvant chemotherapy was associated with 90-day readmissions after robot-assisted radical cystectomy (OR 5.90, 95% CI 3.30-10.90, p <0.01). CONCLUSIONS: Neoadjuvant chemotherapy utilization has significantly increased in the last decade. It was not associated with perioperative surgical morbidity after robot-assisted radical cystectomy.

Predicting intra-operative and postoperative consequential events using machine-learning techniques in patients undergoing robot-assisted partial nephrectomy: a Vattikuti Collective Quality Initiative database study.

OBJECTIVE: To predict intra-operative (IOEs) and postoperative events (POEs) consequential to the derailment of the ideal clinical course of patient recovery. MATERIALS AND METHODS: The Vattikuti Collective Quality Initiative is a multi-institutional dataset of patients who underwent robot-assisted partial nephectomy for kidney tumours. Machine-learning (ML) models were constructed to predict IOEs and POEs using logistic regression, random forest and neural networks. The models to predict IOEs used patient demographics and preoperative data. In addition to these, intra-operative data were used to predict POEs. Performance on the test dataset was assessed using area under the receiver-operating characteristic curve (AUC-ROC) and area under the precision-recall curve (PR-AUC). RESULTS: The rates of IOEs and POEs were 5.62% and 20.98%, respectively. Models for predicting IOEs were constructed using data from 1690 patients and 38 variables; the best model had an AUC-ROC of 0.858 (95% confidence interval [CI] 0.762, 0.936) and a PR-AUC of 0.590 (95% CI 0.400, 0.759). Models for predicting POEs were trained using data from 1406 patients and 59 variables; the best model had an AUC-ROC of 0.875 (95% CI 0.834, 0.913) and a PR-AUC 0.706 (95% CI, 0.610, 0.790). CONCLUSIONS: The performance of the ML models in the present study was encouraging. Further validation in a multi-institutional clinical setting with larger datasets would be necessary to establish their clinical value. ML models can be used to predict significant events during and after surgery with good accuracy, paving the way for application in clinical practice to predict and intervene at an opportune time to avert complications and improve patient outcomes.

A comparative propensity score-matched analysis of perioperative outcomes of intracorporeal vs extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

OBJECTIVE: To compare the perioperative outcomes of intracorporeal (ICUD) vs extracorporeal urinary diversion (ECUD) after robot-assisted radical cystectomy (RARC). PATIENTS AND METHODS: We retrospectively reviewed the prospectively maintained International Robotic Cystectomy Consortium (IRCC) database. A total of 972 patients from 28 institutions who underwent RARC were included. Propensity score matching was used to match patients based on age, gender, body mass index (BMI), American Society of Anesthesiologists Score (ASA) score, Charlson Comorbidity Index (CCI) score, prior radiation and abdominal surgery, receipt of neoadjuvant chemotherapy, and clinical staging. Matched cohorts were compared. Multivariate stepwise logistic and linear regression models were fit to evaluate variables associated with receiving ICUD, operating time, 90-day high-grade complications (Clavien-Dindo Classification Grade ≥III), and 90-day readmissions after RARC. RESULTS: Utilisation of ICUD increased from 0% in 2005 to 95% in 2018. The ICUD patients had more overall complications (66% vs 58%, P = 0.01) and readmissions (27% vs 17%, P = 0.01), but not high-grade complications (21% vs 24%, P = 0.22). A more recent RC era and ileal conduit diversion were associated with receiving an ICUD. Higher BMI, ASA score ≥3, and receiving a neobladder were associated with longer operating times. Shorter operating time was associated with male gender, older age, ICUD, and centres with a larger annual average RC volume. Longer intensive care unit stay was associated with 90-day high-grade complications. Higher CCI score, prior radiation therapy, neoadjuvant chemotherapy, and ICUD were associated with a higher risk of 90-day readmissions. CONCLUSIONS: Utilisation of ICUD has increased over the past decade. ICUD was associated with more overall complications and readmissions compared to ECUD, but not high-grade complications.

Long short-term memory artificial neural network model for prediction of prostate cancer survival outcomes according to initial treatment strategy: development of an online decision-making support system.

PURPOSE: The delivery of precision medicine is a primary objective for both clinical and translational investigators. Patients with newly diagnosed prostate cancer (PCa) face the challenge of deciding among multiple initial treatment modalities. The purpose of this study is to utilize artificial neural network (ANN) modeling to predict survival outcomes according to initial treatment modality and to develop an online decision-making support system. METHODS: Data were collected retrospectively from 7267 patients diagnosed with PCa between January 1988 and December 2017. The analyses included 19 pretreatment clinicopathological covariates. Multilayer perceptron (MLP), MLP for N-year survival prediction (MLP-N), and long short-term memory (LSTM) ANN models were used to analyze progression to castration-resistant PCa (CRPC)-free survival, cancer-specific survival (CSS), and overall survival (OS), according to initial treatment modality. The performances of the ANN and the Cox-proportional hazards regression models were compared using Harrell's C-index. RESULTS: The ANN models provided higher predictive power for 5- and 10-year progression to CRPC-free survival, CSS, and OS compared to the Cox-proportional hazards regression model. The LSTM model achieved the highest predictive power, followed by the MLP-N, and MLP models. We developed an online decision-making support system based on the LSTM model to provide individualized survival outcomes at 5 and 10 years, according to the initial treatment strategy. CONCLUSION: The LSTM ANN model may provide individualized survival outcomes of PCa according to initial treatment strategy. Our online decision-making support system can be utilized by patients and health-care providers to determine the optimal initial treatment modality and to guide survival predictions.

Lessons learned from clinical outcome and tumor features of patients underwent selective artery embolization due to postoperative bleeding following 2076 partial nephrectomies: propensity scoring matched study.

PURPOSE: To evaluate the clinical and tumor characteristics in patients undergoing selective artery embolization (SAE) for bleeding after partial nephrectomy (PN). METHODS: We retrospectively evaluated patients who underwent SAE from 2076 patients who underwent PN. The clinical and tumor characteristics of these patients were analyzed using entire data and propensity score matching (PSM). 76 patients who underwent PN (control, n = 38 patients; SAE, n = 38) were enrolled in PSM. RESULTS: SAE was performed in 41 patients who underwent open (19/1171), laparoscopic (4/60), and robot-assisted PN (18/845). The median period from PN to SAE was 12 days (interquartile range 8-24 day). The most common symptom of 31 (75.61%) patients was gross hematuria, followed by flank pain (3/41). Follow-up imaging revealed large pseudoaneurysm in 7 asymptomatic patients. The main reason for SAE on angiography was pseudoaneurysm (32/41), followed by arteriovenous fistula (5/41). Technical and clinical success was achieved in all patients. There was no statistical difference in the estimated glomerular filtration rate after 1 year, surgical methods, or baseline characteristics between the two groups. Conversely, there was statistically significant difference in ischemic time in the entire data and PSM. In the embolization group, renal masses showed statistically significant endophytic (p = 0.006) and posterior (p = 0.028) characteristics. CONCLUSIONS: SAE is an effective method for controlling postoperative bleeding while preserving renal function after PN. And, we suggest more attentive postoperative surveillance about vascular complications in patients with longer ischemia time or renal masses with endophytic and posterior locations.

Effectiveness of Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, and Extracorporeal Shock Wave Lithotripsy for Treatment of Renal Stones: A Systematic Review and Meta-Analysis.

Background and objectives: To perform a updated systematic review and meta-analysis comparing effectiveness of percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL) for treatment of renal stones (RS). Materials and Methods: A total of 37 studies were included in this systematic review and meta-analysis about effectiveness to treat RS. Endpoints were stone-free rates (SFR), incidence of auxiliary procedure, retreatment, and complications. We also conducted a sub-analysis of ≥2 cm stones. Results: First, PCNL had the highest SFR than others regardless of stone sizes and RIRS showed a higher SFR than ESWL in <2 cm stones. Second, auxiliary procedures were higher in ESWL than others, and it did not differ between PCNL and RIRS. Finally, in <2 cm stones, the retreatment rate of ESWL was higher than others. RIRS required significantly more retreatment procedures than PCNL in ≥2 cm stones. Complication was higher in PCNL than others, but there was no statistically significant difference in complications between RIRS and PCNL in ≥2 cm stones. For ≥2 cm stones, PCNL had the highest SFR, and auxiliary procedures and retreatment rates were significantly lower than others. Conclusions: We suggest that PCNL is a safe and effective treatment, especially for large RS.

The prognostic impact of downgrading and upgrading from biopsy to radical prostatectomy among men with Gleason score 7 prostate cancer.

BACKGROUND: Recently, a new prostate cancer (PC) grading system was introduced, where Gleason score (GS) 7 was divided into 3 + 4 = 7 and 4 + 3 = 7 due to the different prognoses associated with each tumor type. However, whether downgrading or upgrading from needle biopsy (NB) to radical prostatectomy (RP) affects oncologic outcomes is currently unknown. Herein, we investigated the prognostic impact of downgrading and upgrading from NB to RP among men with GS 7 PC. METHODS: We retrospectively reviewed the medical records of 3003 patients with localized PC who underwent RP between 2005 and 2014. We included 692 patients with GS 7 PC on both NB and RP specimens. We analyzed the data using Kaplan-Meier methods and Cox proportional hazard models. RESULTS: Of the 692 patients enrolled in this study, 389 (56.2%) and 303 (43.8%) patients had RP GS 3 + 4 = 7 and RP GS 4 + 3 = 7 PC, respectively. On the basis of NB and RP GS, 264 (38.1%), 125 (18.1%), 142 (20.5%), and 161 (23.3%) patients were classified as 3 + 4/3 + 4, 4 + 3/3 + 4, 3 + 4/4 + 3, and 4 + 3/4 + 3, respectively. Kaplan-Meier curves showed significant differences in biochemical recurrence (BCR)-free survival across the groups (P < .001). In the multivariate analyses, these groups were significantly associated with BCR (4 + 3/3 + 4: hazard ratio [HR], 1.675; 3 + 4/4 + 3: HR, 1.908; and 4 + 3/4 + 3: HR, 2.699). CONCLUSIONS: Downgrading and upgrading from NB to RP was an independent predictor of BCR in men with GS 7 PC, which could be due to the amount of Gleason pattern 4.

Optimal sequencing strategy using docetaxel and androgen receptor axis-targeted agents in patients with castration-resistant prostate cancer: utilization of neutrophil-to-lymphocyte ratio.

PURPOSE: To investigate the prognostic value of neutrophil-to-lymphocyte ratio (NLR) for the selection of the optimal sequencing strategy using docetaxel and androgen receptor axis-targeted (ARAT) agents in patients with M0 or M1 castration-resistant prostate cancer (CRPC). Currently, there is a need to identify biomarkers to guide optimal sequential treatment in CRPC. METHODS: This multicenter, retrospective analysis included 303 consecutive patients initially diagnosed with M0 or M1 CRPC between September 2009 and March 2017. Of these, 52 (17.2%) patients received pre-docetaxel ARAT agents and 189 (62.4%) patients received post-docetaxel ARAT agents. The prognostic ability of NLR at CRPC diagnosis regarding radiographic progression-free survival (rPFS) and cancer-specific survival (CSS) were investigated. For the analysis, the NLR level was dichotomized at 2.5, and evaluated according to sequencing strategy. RESULTS: Multivariate analysis revealed NLR ≥ 2.5 as an independent predictor of a lower risk for CSS. During the median follow-up of 18.5 months, patients with NLR ≥ 2.5 exhibited significantly lower 1-year rPFS (p = 0.011) and 2-year CSS rates (p = 0.005) compared to patients with NLR < 2.5. Among patients with NLR < 2.5, the post-docetaxel ARAT agent sequencing group exhibited higher 1-year rPFS (p = 0.031) and 2-year CSS (p = 0.026) rates compared to the pre-docetaxel ARAT agent sequencing group. Among patients with NLR ≥ 2.5, rPFS and CSS rates were comparable regardless of ARAT agent sequencing. CONCLUSION: NLR ≥ 2.5 at CRPC diagnosis is associated with a lower risk for CSS. Patients with NLR < 2.5 should primarily be offered docetaxel considering the survival benefit of docetaxel-to-ARAT agent sequencing.

Robotic versus laparoscopic radical nephrectomy: a large multi-institutional analysis (ROSULA Collaborative Group).

OBJECTIVE: To compare the outcomes of robotic radical nephrectomy (RRN) to those of laparoscopic radical nephrectomy (LRN) for large renal masses. METHODS: This was a retrospective analysis of RRN and LRN cases performed for large (≥ cT2) renal masses from 2004 to 2017 and collected in the multi-institutional international database (ROSULA: RObotic SUrgery for LArge renal masses). Peri-operative, functional, and oncologic outcomes were compared between each approach. Descriptive analyses were performed and presented as medians with interquartile ranges. Inverse probability of treatment weighting-adjusted multivariable analyses were used to identify predictors of peri-operative complications. Kaplan-Meier analysis and Cox regression models were used to assess survival outcomes. RESULTS: A total of 941 patients (RRN = 404, LRN = 537) were identified. There was no difference in terms of gender, age, and clinical tumor size. Over the study period, RRN had an annual increase of 11.75% (95% CI [7.34, 17.01] p < 0.001) and LRN had an annual decline of 5.39% (95% CI [-6.94, -3.86] p < 0.001). Patients undergoing RRN had higher BMI (27.6 [IQR 24.8-31.1] vs. 26.5 [24.1-30.0] kg/m2, p < 0.01). Operative duration was longer for RRN (185.0 [150.0-237.2] vs. 126 [90.8-180.0] min, p < 0.001). Length of stay was shorter for RRN (3.0 [2.0-4.0] vs. 5.0 [4.0-7.0] days, p < 0.001). RRN cases presented more advanced disease (higher pathologic staging [pT3-4 52.5 vs. 24.2%, p < 0.001], histologic grade [high grade 49.3 vs. 30.4%, p < 0.001], and rate of nodal disease [pN1 5.4 vs. 1.9%, p < 0.01]). Surgical approach did not represent an independent risk factor for peri-operative complications (OR 1.81 95% CI [0.97-3.39], adjusted p = 0.2). The main study limitation is the retrospective design. CONCLUSIONS: This study represents the largest known multi-center comparison between RRN and LRN. The two procedures seem to offer similar peri-operative outcomes. Notably, RRN has been increasingly utilized, especially in the setting of more advanced and surgically challenging disease without increasing the risk of peri-operative complications.

Pathological Characteristics of Prostate Cancer in Men Aged < 50 Years Treated with Radical Prostatectomy: a Multi-Centre Study in Korea.

BACKGROUND: Recently, younger prostate cancer (PCa) patients have been reported to harbour more favourable disease characteristics after radical prostatectomy (RP) than older men. We analysed young men (<50 years) with PCa among the Korean population, paying attention to pathological characteristics on RP specimen and biochemical recurrence (BCR). METHODS: The multi-centre, Severance Urological Oncology Group registry was utilized to identify 622 patients with clinically localized or locally advanced PCa, who were treated with RP between 2001 and 2017. Patients were dichotomized into two groups according to age (< 50-year-old [n = 75] and ≥ 50-year-old [n = 547]), and clinicopathological characteristics were analysed. Propensity score matching was used when assessing BCR between the two groups. RESULTS: Although biopsy Gleason score (GS) was lower in younger patients (P = 0.033), distribution of pathologic GS was similar between the two groups (13.3% vs. 13.9% for GS ≥ 8, P = 0.191). There was no significant difference in pathologic T stage between the < 50- and ≥ 50-year-old groups (69.3% vs. 68.0% in T2 and 30.7% vs. 32.0% in ≥ T3, P = 0.203). The positive surgical margin rates were similar between the two groups (20.0% vs. 27.6%, P = 0.178). BCR-free survival rates were also similar (P = 0.644) between the two groups, after propensity matching. CONCLUSION: Contrary to prior reports, younger PCa patients did not have more favourable pathologic features on RP specimen and showed similar BCR rates compared to older men. These findings should be considered when making treatment decisions for young Korean patients with PCa.

Subcutaneous Fat Distribution is a Prognostic Biomarker for Men with Castration Resistant Prostate Cancer.

PURPOSE: The relationship between body fat distribution and survival remains unclear in patients with castration resistant prostate cancer treated with docetaxel and androgen receptor axis targeted agents. We investigated whether body composition parameters could predict radiographic progression-free and cancer specific survival in patients with castration resistant prostate cancer. MATERIALS AND METHODS: In this multicenter retrospective study we evaluated data on 282 consecutive patients diagnosed with castration resistant prostate cancer between September 2009 and March 2017. The subcutaneous fat index, the visceral fat index and the skeletal muscle index at the diagnosis of castration resistant prostate cancer were determined by computerized tomography data. Survival analyses were performed using the subcutaneous fat, visceral fat and skeletal muscle indexes dichotomized at 39.9, 58 and 52.4 cm2/m2, respectively. RESULTS: At the diagnosis of castration resistant prostate cancer, cancer specific survival was independently predicted using prostate specific antigen levels, Gleason score 8 or greater, performance status, a shorter interval from androgen deprivation therapy to castration resistant prostate cancer and a subcutaneous fat index of less than 39.9 cm2/m2. During the median followup of 16.0 months patients with a subcutaneous fat index of 39.9 cm2/m2 or greater received more docetaxel cycles than patients with a subcutaneous fat index of less than 39.9 cm2/m2. Compared to patients with a subcutaneous fat index of less than 39.9 cm2/m2 those with an index of 39.9 cm2/m2 or greater had better 1-year progression-free and 2-year cancer specific survival (p = 0.009 and 0.021, respectively). CONCLUSIONS: Patients with a subcutaneous fat index of 39.9 cm2/m2 or greater at the diagnosis of castration resistant prostate cancer showed higher progression-free and cancer specific survival rates than those with a subcutaneous fat index of less 39.9 cm2/m2 at diagnosis. The subcutaneous fat index determined by computerized tomography data could serve as a useful objective prognostic factor to discuss patient therapeutic options. Further studies are needed to define the roles of each body composition parameter in relation to pharmacokinetics and oncologic outcome.

Predictors of adverse pathologic features after radical prostatectomy in low-risk prostate cancer.

BACKGROUND: Prostate-specific antigen (PSA) screening more frequently detects early stage prostate cancer (PC). However, adverse pathologic features (APFs) after radical prostatectomy (RP) in low-risk PC occur. Previous related studies had utilized outdated staging criteria or small sample cohorts. In this study, we analyzed predictors of APFs after RP in low-risk PC using classification under the current criteria. MATERIALS AND METHODS: We retrospectively reviewed medical records of 546 low-risk PC patients who had undergone RP. Low-risk PC was defined as PC with clinical T1-T2a, Gleason score ≤ 6, and PSA levels < 10 ng/mL. Clinical and pathological parameters were analyzed to predict APFs. APFs were defined as extracapsular extension (ECE), seminal vesicle invasion (SVI), or positive surgical margins (PSM). We analyzed our data using univariable and multivariable logistic regression analyses, as well as receiver operator characteristics to predict APFs. RESULTS: Among 546 patients, ECE, SVI, and PSM were present in 199 (36.4%), 8 (1.5%), and 179 cases (32.8%), respectively. PSM had a significant correlation with preoperative high PSA levels and number of positive cores obtained. ECE/SVI was also significantly correlated with PSA levels and number of positive cores. As a result, presence of APFs after RP was associated with high PSA levels and large number of positive cores. PSA > 4.5 ng/mL and number of positive cores > 2 in low-risk PC were significantly associated with APFs, and suggested as cut-off values for predicting APFs. CONCLUSIONS: PSA > 4.5 ng/mL and number of positive cores > 2 in low-risk PC were associated with presence of APFs and patients with such records should be considered carefully to provide active surveillance.

Impact of clinical trial participation on survival in patients with castration-resistant prostate cancer: a multi-center analysis.

BACKGROUND: Clinical trial (CT) participation may confer access to new, potentially active agents before their general availability. This study aimed to investigate the potential survival benefit of participation in investigational CTs of novel hormonal, chemotherapeutic, and radiopharmaceutical agents in patients with castration-resistant prostate cancer (CRPC). METHODS: This multi-center, retrospective analysis included 299 consecutive patients with newly diagnosed, non-metastatic or metastatic CRPC between September 2009 and March 2017. Of these, 65 (21.7%) patients participated in CTs pertaining to systemic treatment targeting CRPC and 234 (78.3%) patients received pre-established, standard systemic treatment outside of a CT setting. The survival advantage of CT participation regarding cancer-specific survival (CSS) was investigated. RESULTS: An Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 at CRPC diagnosis was found in a lower proportion CT participants than in non-participants (4.6% vs. 14.9%; p = 0.033). During the median follow-up period of 16.0 months, CT participants exhibited significantly higher 2-year CSS survival rates (61.3% vs. 42.4%; p = 0.003) than did non-participants. Multivariate analysis identified prostate-specific antigen and alkaline phosphatase levels at CRPC onset, Gleason score ≥ 8, ECOG PS ≥2, less number of docetaxel cycles administered, and non-participation in CTs as independent predictors for a lower risk of CSS. CONCLUSIONS: Patients diagnosed with CRPC who participated in CTs exhibited longer CSS durations than non-participants who received pre-established, standard systemic therapy outside of a CT setting. Our findings imply that CT participation is associated with CSS, and that CT participation should be offered to patients with CRPC whenever indicated.

Retzius-sparing robot-assisted radical prostatectomy using the Revo-i robotic surgical system: surgical technique and results of the first human trial.

OBJECTIVE: To evaluate the safety and proficiency of the Revo-i® robotic platform (Meere Company Inc.) in the treatment of prostate cancer (PCa). PATIENTS AND METHODS: A prospective study was carried out on 17 patients with clinically localized PCa treated between 17 August 2016 and 23 February 2017 at our urology department using the Revo-i. Patients underwent Retzius-sparing robot-assisted radical prostatectomy (RS-RARP). The primary objective was to describe the RS-RARP step-by-step surgical technique using the Revo-i. In addition, the safety of the Revo-i was assessed according to intra-operative and the postoperative complications within 30 days of surgery. Early oncological outcomes were also assessed according to surgical margin status and biochemical recurrence (BCR). Continence was defined as use of no or only one pad. Surgeons' satisfaction with the Revo-i was assessed using the Likert scale. RESULTS: All surgeries were completed successfully, with no conversion to open or laparoscopic surgery. The median patient age was 72 years. The median docking time, console time, urethrovesical anastomosis time and estimated blood loss were 8 min, 92 min, 26 min and 200 mL, respectively. One patient was transfused intra-operatively as a result of blood loss of 1 500 mL. Postoperatively, two patients received blood transfusion, and there were no other serious/major complications. The median hospital stay was 4 days. At 3 months, four patients had positive surgical margins, one patient had BCR, and 15 patients were continent. Most of surgeons were satisfied with the Revo-i performance. CONCLUSIONS: The first human study for the treatment of patients with localized PCa using the Revo-i robotic surgical system was carried out successfully. The peri-operative, early oncological and continence outcomes are encouraging. Further prospective studies are warranted to support our preliminary results.

Does robot-assisted radical prostatectomy benefit patients with prostate cancer and bone oligometastases?

OBJECTIVE: To investigate the peri-operative and oncological outcomes of robot-assisted radical prostatectomy (RARP) in patients with oligometastatic prostate cancer (PCa). PATIENTS AND METHODS: We retrospectively reviewed the records of 79 patients with oligometastatic PCa treated with RARP or androgen deprivation therapy (ADT) between 2005 and 2015 at our institution. Of these 79 patients, 38 were treated with RARP and 41 were treated with ADT without local therapy. Oligometastatic disease was defined as the presence of five or fewer hot spots detected by preoperative bone scan. We evaluated peri-operative outcomes, progression-free survival (PFS), and cancer-specific survival (CSS). We analysed data using Kaplan-Meier methods, with log-rank tests and multivariate Cox regression models. RESULTS: Patients treated with RARP experienced similar postoperative complications to those previously reported in RP-treated patients, and fewer urinary complications than ADT-treated patients. PFS and CSS were longer in RARP-treated compared with ADT-treated patients (median PFS: 75 vs 28 months, P = 0.008; median CSS: not reached vs 40 months, P = 0.002). Multivariate analysis further identified RARP as a significant predictor of PFS and CSS (PFS: hazard ratio [HR] 0.388, P = 0.003; CSS: HR 0.264, P = 0.004). CONCLUSIONS: We showed that RARP in the setting of oligometastatic PCa is a safe and feasible procedure which improves oncological outcomes in terms of PFS and CSS. In addition, our data suggest that RARP effectively prevents urinary tract complications from PCa. The study highlights results from expert surgeons and highly selected patients that cannot be extrapolated to all patients with oligometastatic PCa; to confirm our findings, large, prospective, multicentre studies are required.