1.Application of mpMRI-TRUS AI fusion targeted transperineal biopsy under local anesthesia with"one-plane three-point"dual probe ultrasound localization
Yongjun YANG ; Xianya HE ; Yiming ZENG ; Qiang LU ; Yuanwei LI
Journal of Modern Urology 2024;29(6):540-546
Objective To explore the efficacy and safety of multi-parametric magnetic resonance imaging and transrectal ultrasonography(mpMRI-TRUS)fusion targeted transperineal biopsy(TPB)under local anesthesia(LA)with"one-plane three-point"dual probe ultrasound localization.Methods Clinical data of 134 suspected prostate cancer(PCa)patients treated with this method in our hospital during Jan.and Sep.2023 were retrospectively analyzed.The same doctor applied visual analog scale(VAS)and visual digital scale(VNS)to evaluate the pain level and satisfaction of patients during TPB(VAS-1 and VNS-1)and 1 hour after TPB(VAS-2 and VNS-2),and recorded the perioperative clinical data and detection rate of clinically significant prostate cancer(csPCa).Results VAS-1 score was(1.60±0.68)and VAS-2 score was(1.13±0.55);VNS-1 score was(2.84±0.41),and VNS-2 score was(3.74±0.44).The operation time was(16.12±3.35)minutes.The postoperative pathological results showed that the detection rate of csPCa was 65.67%(88/134).According to the PI-RADS score in subgroup analysis,the detection rates of patients with PI-RADS scores of 2,3,4,and 5 were 23.08%(6/26),52.94%(18/34),62.50%(15/24)and 98.00%(49/50),respectively.After TPB,gross hematuria occurred in 20.90%(28/134)patients,and urinary retention occurred in 4.00%(5/125)patients,which were relieved after symptomatic treatment.No complications such as perineal puncture area hematoma,urinary tract infection,hematospermia,vagal nerve reaction,and septic shock occurred.Conclusion The mpMRI-TRUS fusion targeted TPB under LA with"one-plane three-point"dual probe ultrasound localization provides a feasible and tolerable surgical procedure for suspected PCa patients with a high detection rate of csPCa,which is worthy of further clinical promotion and application.
2.Neutrophil-to-lymphocyte ratio may help predict pediatric testicular torsion in chlidren with acute scrotal pain before surgery
Xianya HE ; Chen WANG ; Yongjun YANG ; Junjie CHEN ; Xuecheng WU ; Zhuo LI ; Zhe LIU ; Guangqing SONG ; Yili TENG ; Jia CHEN ; Hongwei WANG ; Huayi ZHENG ; Yuanwei LI ; Qiang LU
Journal of Modern Urology 2024;29(9):785-789
Objective To explore the feasibility and accuracy of neutrophil-to-lymphocyte ratio(NLR)in the prediction of testicular torsion(TT)in children with acute scrotal pain.Methods A retrospective case-control study was performed on 158 pediatric patients with ultrasound suspicion of TT who underwent surgical testicular examination during Jan.2017 and Jan.2024.The patients were divided into TT group and non-TT group.Clinical data and laboratory data at admission were analyzed.Sensitivity and specificity of NLR to TT were determined with the area under the curve(AUC)represented on the receiver operating characteristic(ROC)curves.Results There were with no statistically significant differences in clinical data between the two groups(P>0.05).The NLR was significantly higher in the TT group than in the non-TT group[(4.82±2.37)vs.(2.85±0.75),P<0.05].The optimal cut-off value of TT predicted by NLR was 2.07,the AUC was 0.809(95%CI:0.709-0.909),and the sensitivity and specificity were 97.9%and 93.3%,respectively,which were significantly higher than other factors.Conclusion For suspicious ultrasound diagnosis of pediatric acute scrotal pain cases,NLR can be used to predict the possibility of TT and may help to evaluate the urgent surgical treatment in these patients.
3.Application Value of Transperineal Biopsy Using Electromagnetic Needle Tracking Combined with Rapid Paraffin-Embedded Section of Small Specimen in Diagnosis of Prostate Cancer
Yongjun YANG ; Yiming ZENG ; Xianya HE ; Qiang LU ; Yuanwei LI
Cancer Research on Prevention and Treatment 2024;51(10):864-869
Objective To explore the application value of mpMRI-TRUS multi-modal image fusion transperineal biopsy technique using electromagnetic needle tracking under local anesthesia combined with rapid paraffin-embedded section of small specimen in the diagnosis of prostate cancer.Methods The clinicopathological data of 138 patients with PI-RADS score≥3 who underwent mpMRI-TRUS image fusion transperineal biopsy using electromagnetic needle tracking under local anesthesia were retrospectively analyzed.AI technology was used to fuse mpMRI and TRUS multi-mode images,and two-core targeted biopsies were performed on suspicious lesions,followed by 12-core systematic biopsies.The specimens obtained from targeted biopsies were sent for rapid paraffin-embedded section pathological examination,and the detection rates of csPCa were compared.Results The detection rate of csPCa in 138 patients was 71.01% .The detection rates of csPCa in targeted biopsies and systematic biopsies were 62.32% and 70.29%,respectively(P=0.20).The detection rate of combined biopsies was higher than those of targeted biopsies and systematic biopsies,but the difference was not statistically significant(P>0.05).The detection rates of csPCa in targeted biopsies,systematic biopsies,and combined biopsies in patients with PI-RADS score 3 were 30.95%,38.10%,and 40.48%,respectively;and the percentages were 52.94%,61.76%,and 61.76% in patients with PI-RADS score 4,respectively;and the percentages were 90.32%,96.77%,and 96.77% in patients with PI-RADS score 5,respectively,without statistically significant difference(all P>0.05).In the subgroups with PI-RADS scores of 3,4,and 5,the missed diagnosis rates of csPCa by targeted biopsies were 23.53%,14.29%,and 6.67%,respectively.Conclusion For patients with suspected prostate cancer and PI-RADS v2.1 score≥3,transperineal biopsy using electromagnetic needle tracking combined with rapid paraffin-embedded section of small specimen can obtain pathological results rapidly and has good diagnostic accuracy.However,combined biopsy is still the most suitable method for the diagnosis of prostate cancer at present.
4.Prospective Cohort Investigation on Physical Activity of Osteoporosis Outcomes (PAOPO) in Jidong:Objectives,Study Design,and Baseline Characteristics
Yang JINGZHI ; Shen HAO ; Wang SICHENG ; Bai LONG ; Geng ZHEN ; Jing YINGYING ; Xu KE ; Liu YUHE ; Wu WENQIAN ; Zhang HAO ; Zhang YUANWEI ; Li ZUHAO ; Wang CHUANDONG ; Wang GUANGCHAO ; Chen XIAO ; Su JIACAN
Biomedical and Environmental Sciences 2024;37(9):1067-1079
Objective The aim of this study was to investigate the prospective association between physical activity (PA),independently or in conjunction with other contributing factors,and osteoporosis (OP) outcomes. Methods The Physical Activity in Osteoporosis Outcomes (PAOPO) study was a community-based cohort investigation. A structured questionnaire was used to gather the participants' sociodemographic characteristics. Bone mineral density (BMD) measurements were performed to assess OP outcomes,and the relationship between BMD and OP was evaluated within this cohort. Results From 2013 to 2014,8,471 participants aged 18 years and older were recruited from Tangshan,China's Jidong community. Based on their PA level,participants were categorized as inactive,moderately active,or very active. Men showed higher physical exercise levels than women across the activity groups. BMD was significantly higher in the very active group than in the moderately active and inactive groups. Individuals aged>50 years are at a higher risk of developing OP and osteopenia. Conclusion The PAOPO study offers promising insights into the relationship between PA and OP outcomes,encouraging the implementation of PA in preventing and managing OP.
5.A trinity strategy for the treatment of multiple orthopedic trauma and assessment of its clinical application
Xiao CHEN ; Guangchao WANG ; Hao ZHANG ; Kaiyang LYV ; Qirong ZHOU ; Yunfei NIU ; Yan HU ; Yuanwei ZHANG ; Zuhao LI ; Hao SHEN ; Jin CUI ; Sicheng WANG ; Zhengrong GU ; Zhen GENG ; Dongliang WANG ; Zhehao FAN ; Shihao SHENG ; Chongru HE ; Jun FEI ; Yunfeng CHEN ; Haodong LIN ; Guohui LIU ; Zhiyong HOU ; Jiacan SU
Chinese Journal of Trauma 2024;40(10):888-896
Objective:To explore the clinical value of a trinity strategy for the treatment of multiple orthopedic trauma.Methods:A retrospective case series study was conducted to analyze the clinical data of 1 267 patients with multiple orthopedic trauma admitted to Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and the First Affiliated Hospital of Navy Medical University from June 2013 to May 2023, including 862 males and 405 females, aged 18-93 years [(55.2±19.8)years]. Associated injuries included hemorrhagic shock in 632 patients, traumatic wet lung in 274, cranial injuries in 135, abdominal and pelvic bleeding in 116, pneumothorax in 89, urinary injury in 13, and vesical rupture in 8. All the patients were treated with the trinity strategy and the treatment process was divided into the phases of first aid, remodeling, and rehabilitation. The first aid phase focused on stabilizing symptoms and saving lives; the remodeling phase centered on restoring the anatomical structure and alignment; the rehabilitation phase aimed for functional recovery through the integration of both Western and traditional Chinese medicine. The all-cause mortality within 30 days after surgery and fracture healing time were calculated; the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, Hospital for Special Surgery (HSS) knee score and the American Orthopedic Foot & Ankle Society (AOFAS) ankle-hindfoot score at the last follow-up and the overall excellent and good rate of all joint function scores were measured. The short form health survey (SF-36) scores were collected preoperatively and at 6 months postoperatively, including 8 aspects such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The incidence of postoperative complications was recorded.Results:All the patients were followed up for 6-18 months [(10.2±4.2)months]. The mortality rate during the acute phase (within 30 days after surgery) was 2.37% with 12 deaths due to hemorrhagic shock, 10 due to traumatic brain injury, 6 due to multiple organ dysfunction syndrome (MODS), and 2 due to pulmonary infection. The average fracture healing time averaged 3.8-18 months [(11.5±4.2)months], with 89.49% of the patients having bone union within 12 months after surgery, 8.93% having bone union within 18 months after surgery, and 1.58% undergoing reoperation. For the patients with internal fixation failure and nonunion, the average healing time was extended to (10.2±2.2)months and (13.7±3.3)months respectively. At the last follow-up, the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, HSS knee score, and AOFAS ankle-hindfoot score were 83.93%, 90.24%, 94.12%, 85.57%, 88.46%, and 92.31% respectively, with an overall excellent and good rate of 89.11%. At 6 months after surgery, the SF-36 scores of all the patients in the eight dimensions,including the physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health were (74.4±8.6)points, (44.7±14.4)points, (77.4±10.9)points, (68.4±18.2)points, (72.5±16.0)points, (76.8±8.7)points, (49.9±17.6)points, and (72.8±17.9)points, significantly improved compared with those before operation [(63.4±12.7)points, (30.9±17.4)points, (56.4±18.0)points, (55.4±24.7)points, (53.5±21.0)points, (55.8±24.3)points, (36.9±24.0)points, (58.8±21.6)points] ( P<0.01). Complications of different degrees occurred in 214 patients (16.89%), including lung infections in 118 patients (9.31%), lower extremity deep vein thrombosis in 50(3.95%), pressure injuries in 26(2.05%), internal fixation failure in 12(0.95%), and nonunion in 8(0.63%). Conclusions:The trinity strategy provides whole-process management, personalized treatment, and overall rehabilitation for multiple orthopedic trauma. It can decrease mortality, shorten fracture healing time, improve joint function and quality of life, and reduce the incidence of complications.
6.Application of Magnetic Resonance Imaging and Transrectal Ultrasound Image Fusion Targeted Transperineal Biopsy Technique Using Electromagnetic Needle Tracking Under Local Anaesthesia
Yongjun YANG ; Xianya HE ; Yiming ZENG ; Qiang LU ; Yuanwei LI
Cancer Research on Prevention and Treatment 2024;51(1):55-60
Objective To explore the effect and safety of magnetic resonance imaging and transrectal ultrasound (mpMRI-TRUS) image fusion targeted transperineal biopsy technique using electromagnetic needle tracking under local anesthesia. Methods We retrospectively analyzed the clinical and pathological data of 81 patients with mpMRI-TRUS image fusion targeted transperineal prostate biopsy using electromagnetic needle tracking under local anesthesia. Visual analog scale (VAS) and visual numeric scale (VNS) were used to evaluate the pain level and satisfaction of patients during prostate biopsy (VAS-1 and VNS-1), one hour after puncture (VAS-2 and VNS-2), and one day after surgery (VAS-3 and VNS-3). The perioperative clinical data and tumor positive rate of postoperative biopsy were recorded. Results The average prostate volume of 81 patients was 53.39±29.46 cm3. The PSA values of patients with PI-RADS scores of 2, 3, 4, and 5 were 9.14±2.31, 9.95±4.10, 14.77±6.36, and 32.17±24.39 ng/ml, respectively. The scores of VAS-1, VAS-2, and VAS-3 were 1.70±0.73, 1.16±0.58, and 0.53±0.55, respectively; the scores of VNS-1, VNS-2, and VNS-3 were 2.74±0.44, 3.69±0.46, and 3.84±0.37, respectively. The average surgical time was 17.47±3.44 minutes. Postoperative pathological results showed that the tumor positive rate of targeted prostate biopsy was 64.20%. According to the PI-RADS score for subgroup analysis, the tumor positive rates of patients with PI-RADS scores of 2, 3, 4, and 5 were 21.43%, 44.44%, 61.11%, and 96.77%, respectively. After transperineal prostate biopsy, gross hematuria occurred in 19.75% patients, and urinary retention occurred in 3.70%. The latter were relieved after symptomatic treatment. All patients did not experience complications, such as perineal puncture area hematoma, urinary tract infection, hematospermia, hematoma in perineal puncture area, urinary tract infection, hematospermia, vagus nerve reaction, or septic shock. Conclusion For suspected prostate cancer patients, mpMRI-TRUS image fusion targeted transperineal biopsy technique using electromagnetic needle tracking under local anesthesia is a feasible and easily tolerated surgical procedure. It has good safety and high tumor positive-detection rate, indicating that this technique is worthy of further clinical promotion and application.
7.Efficacy of transurethral plasmakinetic resection of the prostate using a small-caliber resectoscope for benign prostatic hyperplasia with mild urethral stricture.
Zhiwei ZHU ; Zhibiao QING ; Junhuan HE ; Xuecheng WU ; Wuxiong YUAN ; Yixing DUAN ; Yuanwei LI ; Mingqiang ZENG
Journal of Central South University(Medical Sciences) 2024;49(11):1751-1756
OBJECTIVES:
The conventional Fr26 resectoscope is difficult to use in patients with benign prostatic hyperplasia (BPH) complicated by urethral stricture. This study aims to evaluate the safety and efficacy of transurethral plasmakinetic resection of the prostate (PKRP) using a small-caliber (Fr18.5) plasmakinetic resectoscope combined with urethral dilation in patients with BPH and mild urethral stricture.
METHODS:
A retrospective analysis was conducted on 37 patients with BPH and mild urethral stricture treated at the Department of Urology, Hunan Provincial People's Hospital from January 2023 to December 2023. All patients underwent PKRP with a small-caliber plasmakinetic resectoscope, followed by routine placement of a Fr20 three-way Foley catheter for continuous bladder irrigation. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-voiding residual urine volume (PVR), and Quality of Life (QOL) scores were compared before and after surgery. Perioperative indicators (intraoperative bleeding, operative time, postoperative catheterization time, and postoperative hospital stay) and complications were recorded.
RESULTS:
The median age was 69 years, and the median duration of voiding difficulty was 36 months. Median total prostate specific antigen (T-PSA) was 2.095 ng/mL, free prostate specific antigen (F-PSA) 0.561 ng/mL, and F/T ratio 0.3. Median prostate diameter was 48 mm and volume 41 mL. All 37 surgeries were completed successfully: 11 had external meatal stricture, 19 had mild anterior urethral stricture, and 7 had mild posterior urethral stricture (1 patient with a 1 cm pseudo-blind tract near the membranous urethral). Operative time was (2.4±0.7) hours, blood loss was (40±29) mL, median catheterization duration was 7 days, and median hospital stay was 7 days. No cases of postoperative urinary incontinence, recurrent hematuria, or sepsis occurred, and patients were satisfied with the surgical outcome. At 3 to 6 months follow-up, IPSS, Qmax, PVR, and QOL scores significantly improved compared to preoperative levels (all P<0.01), with no cases of urethral stricture progression or new-onset stricture.
CONCLUSIONS
PKRP using a small-caliber plasmakinetic resectoscope is safe and effective for treating BPH with mild urethral stricture. It offers advantages such as minimal trauma, rapid postoperative recovery, and a lower risk recovery, and a lower risk of aggravating urethral injury.
Humans
;
Male
;
Prostatic Hyperplasia/complications*
;
Urethral Stricture/complications*
;
Retrospective Studies
;
Aged
;
Transurethral Resection of Prostate/instrumentation*
;
Middle Aged
;
Treatment Outcome
;
Quality of Life
;
Aged, 80 and over
8.Y-shaped osteotomy in the apical vertebra for treating congenital complex rigid scoliosis:at least 2-year follow-up
Ze GAO ; Kai LI ; Xuhong XUE ; Sheng ZHAO ; Shixiong WANG ; Yuanwei LI ; Fanhui XI ; Qi ZHANG
Chinese Journal of Surgery 2023;61(11):950-958
Objective:To investigate the clinical outcome of the coronal Y-shaped osteotomy in the apical vertebra for treating congenital complex rigid scoliosis.Methods:A retrospective analysis was conducted on 66 cases who underwent Y-shaped osteotomy treatment for congenital complex rigid scoliosis in the uppermost vertebra at the Department of Orthopedics,the Second Hospital of Shanxi Medical University from June 2007 to August 2020. There were 19 males and 47 females,with an age of (13.1±5.3) years(range:2 to 30 years).Classification of congenital scoliosis:25 cases (37.9%) were incomplete,13 cases (19.7%) were dysarthritic,and 28 cases (42.4%) were mixed. There were 25 cases (37.9%) with thoracic or rib malformations. 45 cases (68.2%) were complicated with spinal cord malformation.The main radiological indicators included Cobb angle of the curvature,Cobb angle of the local bend,apical vertebral translation (AVT),trunk shift (TS),thoracic trunk shift (TTS),radiographic shoulder height (RSH),coronal balance and sagittal vertebral axis. The preoperative,postoperative immediate,and last follow-up radiological indicators were collected and the operation time,blood loss,hospitalization time,and operation-related complications were recorded. Data were compared by repeated measure ANOVA and paired- t test. Results:All patients underwent surgery successfully. The duration of the first surgery was (221.4±52.8) minutes,and the blood loss during the first surgery was (273.2±41.8) ml. The length of the first hospital stay was (8.8±1.7) days.Unilateral fixation was performed in 19 cases (28.8%),while bilateral fixation was performed in 47 cases (71.2%). The fused segments were 7.5±2.9,and the vertebral pedicle screw density was (68.5±20.6)%. The follow-up time for the 66 patients was (36.7±17.0) months(range:24 to 102 months).The main curve Cobb Angle was improved from (58.5±18.9)°before surgery to (21.1±11.8)°after surgery,and was (23.6±15.3) ° at the last follow-up( F=273.957, P<0.01),with a correction rate of 66.2%. Segmental curve Cobb Angle was improved from (47.9±18.0)° to (16.0±11.3)° after surgery,and was (16.8±12.8) °at the last follow-up ( F=270.483, P<0.01)with a correction rate of 69.2%. The AVT,TS,TTS and RSH values improved significantly at the final follow-up (all P<0.05),while coronal balance and sagittal vertical axis were maintained without significant differences between pre-operation and post-operation(both P>0.05). A total of 5 patients underwent staged operation,all of which were residual scoliosis aggravated after the first stage of orthosis operation and had good prognosis after the second stage of operation. Conclusions:Y-shaped osteotomy for the treatment of congenital rigid scoliosis results in good clinical and radiological outcomes without serious complications. This procedure can be considered as an option for the treatment of congenital complex rigid scoliosis.
9.Y-shaped osteotomy in the apical vertebra for treating congenital complex rigid scoliosis:at least 2-year follow-up
Ze GAO ; Kai LI ; Xuhong XUE ; Sheng ZHAO ; Shixiong WANG ; Yuanwei LI ; Fanhui XI ; Qi ZHANG
Chinese Journal of Surgery 2023;61(11):950-958
Objective:To investigate the clinical outcome of the coronal Y-shaped osteotomy in the apical vertebra for treating congenital complex rigid scoliosis.Methods:A retrospective analysis was conducted on 66 cases who underwent Y-shaped osteotomy treatment for congenital complex rigid scoliosis in the uppermost vertebra at the Department of Orthopedics,the Second Hospital of Shanxi Medical University from June 2007 to August 2020. There were 19 males and 47 females,with an age of (13.1±5.3) years(range:2 to 30 years).Classification of congenital scoliosis:25 cases (37.9%) were incomplete,13 cases (19.7%) were dysarthritic,and 28 cases (42.4%) were mixed. There were 25 cases (37.9%) with thoracic or rib malformations. 45 cases (68.2%) were complicated with spinal cord malformation.The main radiological indicators included Cobb angle of the curvature,Cobb angle of the local bend,apical vertebral translation (AVT),trunk shift (TS),thoracic trunk shift (TTS),radiographic shoulder height (RSH),coronal balance and sagittal vertebral axis. The preoperative,postoperative immediate,and last follow-up radiological indicators were collected and the operation time,blood loss,hospitalization time,and operation-related complications were recorded. Data were compared by repeated measure ANOVA and paired- t test. Results:All patients underwent surgery successfully. The duration of the first surgery was (221.4±52.8) minutes,and the blood loss during the first surgery was (273.2±41.8) ml. The length of the first hospital stay was (8.8±1.7) days.Unilateral fixation was performed in 19 cases (28.8%),while bilateral fixation was performed in 47 cases (71.2%). The fused segments were 7.5±2.9,and the vertebral pedicle screw density was (68.5±20.6)%. The follow-up time for the 66 patients was (36.7±17.0) months(range:24 to 102 months).The main curve Cobb Angle was improved from (58.5±18.9)°before surgery to (21.1±11.8)°after surgery,and was (23.6±15.3) ° at the last follow-up( F=273.957, P<0.01),with a correction rate of 66.2%. Segmental curve Cobb Angle was improved from (47.9±18.0)° to (16.0±11.3)° after surgery,and was (16.8±12.8) °at the last follow-up ( F=270.483, P<0.01)with a correction rate of 69.2%. The AVT,TS,TTS and RSH values improved significantly at the final follow-up (all P<0.05),while coronal balance and sagittal vertical axis were maintained without significant differences between pre-operation and post-operation(both P>0.05). A total of 5 patients underwent staged operation,all of which were residual scoliosis aggravated after the first stage of orthosis operation and had good prognosis after the second stage of operation. Conclusions:Y-shaped osteotomy for the treatment of congenital rigid scoliosis results in good clinical and radiological outcomes without serious complications. This procedure can be considered as an option for the treatment of congenital complex rigid scoliosis.
10.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
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Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
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East Asian People
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Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone

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