ABSTRACT
Objective:To compare the predictive efficacy of different versions of Briganti nomogram in predicting lymph node metastasis in Chinese patients with prostate cancer.Methods:From October 2012 to April 2021, 583 cases with prostate cancer who underwent radical prostatectomy and pelvic lymphadenectomy by a single surgeon were retrospectively collected. For all 583 patients, the median age was 67 (63, 72)years old, median BMI was 24.39(22.58, 26.35)kg/m 2, median PSA was 22(12, 43)ng/ml. There were 65 cases, 357 cases, 140 cases and 21 cases with clinical stage T 1, T 2, T 3 and T 4. There were 30 cases, 109 cases, 104 cases, 160 cases and 180 cases for ISUP 1 group, 2 group, 3 group, 4 group and 5 group. The median percentage of positive biopsy cores was 50%(33%-83%). The validated nomograms were Briganti's 2006, 2012 and 2017. Compared with the 2006 edition, the new variables in the 2012 edition and 2017 edition were the percentage of positive biopsy cores, the percentage of the highest grade positive biopsy cores and the percentage of the lower grade positive biopsy cores, respectively. The validation patients for the 2006, 2012 and 2017 versions of nomogram were 560, 513 and 357, respectively, which were used as the differential validation cohorts. A total of 357 patients were validated for all three versions of nomogram, which was considered as the general validation cohort. The area under the receiver operating characteristic (ROC) curve (AUC), calibration curve and clinical decision curve analysis were used to evaluate the predictive efficacy of the three versions of nomograms. Results:In the differential validation cohort, the AUC values of the 2006, 2012 and 2017 versions of the nomogram were 0.738(95% CI 0.690-0.785), 0.765(95% CI 0.717-0.814) and 0.779(95% CI 0.724-0.834), respectively. There was no significant difference in AUC values among versions ( P>0.05). In the general validation cohort, the AUC values of the three versions of the nomogram were as follows 0.744(95% CI 0.682-0.805), 0.759(95% CI 0.700-0.818) and 0.779(95% CI 0.724-0.834), respectively. There was no significant difference in AUC values among the three versions ( P>0.05). The calibration curve showed that the prediction probability of 2012 and 2017 editions was in good agreement with the actual risk within the prediction probability of 0-40%. Analysis of the clinical decision curve showed that the clinical benefit of the 2012 version was greater than that of the other two versions in the prediction threshold of 0-33%. Conclusion:Briganti nomogram is suitable for predicting pelvic lymph node metastasis in Chinese patients with prostate cancer. The 2012 and 2017 versions of the nomogram have good predictive performance, and the versions can be selected according to the predictive variables that can be provided.
ABSTRACT
Objective:To evaluate the safety and efficacy of Toumai ? endoscopic robotic system in radical prostatectomy. Methods:This study was a single-center phase Ⅲ randomized controlled study. From June 2020 to January 2021, patients with prostate cancer who met the inclusion criteria in Changhai Hospital Affiliated to Naval Military Medical University were divided into the experimental group and the control group by random table method. Inclusion criteria included aged 18 to 80 years, pathologically diagnosed as prostate cancer, clinical stage ≤T 2N 0M 0. Exclusion criteria included patients requiring emergency surgery, having serious cardiovascular diseases and cannot tolerate surgery, having participated in other investigational drug or device clinical trials within the last 3 months. The experimental group used Toumai ? laparoscopic robotic system, and the continence group used the Da Vinci robotic system. The patients in both groups underwent radical prostatectomy via a transabdominal approach, which was performed by two surgeons. The clinical characteristics between the two groups were compared, related adverse events were recorded, and PSA and urinary continence were followed up one month after the operation. Results:A total of 44 patients were enrolled in this study, including 22 cases in the experimental group and 22 cases in the control group. The mean age of patients in the trial group and the control group was (67.7±7.5) years and (66.4±6.3) years, respectively. The median PSA at diagnosis was 10.5 (7.7, 23.7) ng/ ml and 13.5 (8.9, 24.7) ng/ ml, respectively. Biopsy Gleason score of 6, 7, 8 and 9 in experimental group were 13.6% (3/22), 68.2% (15/22), 4.5% (1/22) and 13.6% (3/22), respectively, and in the control group were 4.5% (1/22), 59.1% (13/22), 22.7% (5/22) and 13.6% (3/22) respectively. The middle risk and high risk group in the experimental group was 50.0% (11/22), 50.0% (11/22), and the control group was 36.4% (8/22), 63.6% (14/22). There was no statistical difference between the two groups.The operations in both groups were successfully performed. There were no conversions to open or laparoscopic surgeries, and no Clavien-Dindo grade Ⅲcomplications. There was no significant difference in the estimated blood loss during the operation [(109.1±51.6)ml vs.(94.5±51.6)ml] and the blood transfusion rate [9.1%(2/22)vs. 4.5%(1/22)] in both groups. The operation time was significantly higher in the experimental group than that in the control group [164.5(130.5, 214.3) min vs. 88.0(65.3, 110.5)min, P<0.001]. The positive rate of surgical margin was 13.6% (3/22) in the experimental group and 36.4% (8/22) in the control group, respectively, showing no significant difference. The pathologic stages of pT 2, pT 3a and pT 3bin experimental group were 63.6% (14/22), 13.6% (3/22) and 22.7% (5/22), respectively, while those in control group were 36.3% (8/22), 40.9% (9/22) and 22.7% (5/22), respectively, showing no significant difference. The recovery rates of urine control in the experimental group and the control group were 22.7% (5/22) and 22.7% (5/22), respectively. The median PSA in the experimental group and the control group were 0.055 (0.021, 0.103) ng/ ml and 0.032 (0.010, 0.089) ng/ ml, respectively, with no statistical difference. Conclusions:The Toumai ? endoscopic robotic system can successfully perform radical prostatectomy, based on insignificant difference from Da Vinci robotic system in safety and efficacy. The short-term follow-up showed that tumor control and urinary continence have recovered well in the test group. The long-term effect of the new system on tumor control and functional recovery after radical prostatectomy needs further multi-center studies.