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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.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
Frailty is the clinical syndrome that occurs due to an increase in personal vulnerability and a decline in the ability to maintain one′s internal balance, which is closely related to the development of bladder cancer in the elderly. The research on frailty of elderly patients with bladder cancer in China is still in its infancy. This article discussed the risks of bladder cancer and frailty, the necessity of preoperative frailty assessment in patients with bladder cancer, commonly used assessment tools, and summarized the limitations of the existing evaluation tools to provide reference for further developing and improving the frailty evaluation tools and applications for bladder cancer patients research provides reference.
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Objective:To explore the diagnostic value of quantitative 99Tc m-hydrazinonicotinamide(HYNIC)-prostate specific membrane antigen (PSMA) SPECT/CT in patients with prostate cancer. Methods:From November 2018 to March 2021, the data of 56 patients ((69.8±8.0) years) with clinically suspected prostate cancer, who had elevated radioactive uptake in prostate on 99Tc m-HYNIC-PSMA SPECT/CT images in Henan Provincial People′s Hospital, were retrospectively analyzed. According to the pathological results, patients were divided into prostate cancer group ( n=45) and non-prostate cancer group ( n=11). The xSPECT-QUANT software was used to quantitatively analyze the high uptake area of the prostate, and SUV max was measured. The independent-sample t test, Mann-Whitney U test, ROC curve and Spearman correlation analysis were used for data analysis. Results:The prostate cancer group had higher SUV max than non-prostate cancer group (10.79±5.96 vs 3.60±1.27; t=7.43, P<0.001). When SUV max≥6.46, the AUC of prostate cancer was 0.887, with the diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 73.3%(33/45), 11/11, 100%(33/33), 47.8%(11/23), 78.6%(44/56), respectively. The SUV max of prostate cancer group was positively correlated with Gleason score ( rs=0.632, P<0.001). The SUV max of 29 patients with Gleason score≥8 was higher than that of 16 patients with Gleason score≤7 ( z=-3.89, P<0.001). There was no statistical difference in PSA level between patients with Gleason score≤ 7 and patients with non-prostate cancer ( z=-1.63, P=0.110), but the SUV max was significantly different ( z=-2.22, P=0.026). The SUV max of 23 patients with metastases was higher than that of 22 patients without metastasis (12.99±5.85 vs 8.50±5.28; t=2.69, P=0.010). ROC analysis showed that the AUC was 0.709; with SUV max≥13.02 as the threshold, the sensitivity for diagnosing prostate cancer metastases was 56.5%(13/23), the specificity was 86.4%(19/22), and the accuracy was 71.1%(32/45). Conclusions:The 99Tc m-HYNIC-PSMA SPECT/CT quantitative analysis is feasible in patients with prostate cancer. SUV max of 99Tc m-HYNIC-PSMA can be used in the diagnosis of prostate cancer, assessment of the malignancy and prediction of metastasis.
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Objective To explore the operating skills of finding and dissecting renal pedicle in retroperitoneosocpic radical nephrectomy.Methods From April 2011 to April 2015,224 patients with renal tumors were treated by retroperitoneosocpic radical nephrectomy.Along the ureteral ascending methodis used to find renal pedicle for 126 cases(the research group):First found ureter in the iliac crest,the ureter was nearest psoas major here and waseasy to find.Along the ureteral upward until to the renal pelvis and the superior border of renal pelvis is the renal pedicle.77 male and 49 female cases,Age 42 to 84 years,(56.6 ± 9.0) years old on average.Sixty-nine tumors were located in left kidney,and 59 in the right kidney.The mean diameter of renal tumor was(5.3 ± 1.1)cm.There were 25 cases of T1a N0 M0,75 T1b N0 M0,23 of T2 N0 M0,3 of T1bN1M0.Over the same period uplift in he kidney central method is used to find renal pedicle for 98 cases.64 male and 34 female cases,Age 27 to 81 years,(57.9 ± 8.3)years old on average.52 tumors were located in left kidney,and 46 in the right kidney.The mean diameter of renal tumor was (5.5 ± 1.4)cm.There were 19 cases of T1aN0M0,61 T1bN0M0,16 of T2N0M0,2 of T1bN1 M0.Results The differences were significant for Looking for renal pedicle time(2.2 ± 1.1 vs.4.5 ±2.0) min,operation time (73.7 ±67.3 vs.90.1 ±87.5)min,hemorrhage volume(69.8 ±42.7 vs.89.7 ±89.2) ml,the incidence of complications (3 vs.9) between the study group and the control group (P < 0.05).The difference were not significant in postoperative hospital stay (7.5 ± 0.8 vs.7.3 ± 0.8) d,exhaust time (2.1 ± 0.6 vs.2.2 ± 0.6) d between two group.All the operations were performed successfully in the research group,with no conversion to open and transfusion.Major complications included 3 cases of vessel injury.Hemostasis was performed with metal clips and suture.In the control group,ena cava rupture in 3 cases,left lumbar veins rupture in 3 cases,retroperitoneal hematoma in 2 case,mild pulmonary embolism in 1 case.two case performed open operation owing to vena cava rupture.The vena cava rupture transit open surgery in 2 cases,and Hemostasis was performed with metal clips in 1 case of vena cava rupture and on the left side of the lumbar veins rupture was managed by suture,titanium clips and bipolar electrocautery;Retroperitoneal hematoma improved by conservative treatment;Pulmonary embolism improved by medical consultation after thrombolysis.Conclusions Retroperitoneosocpic radical nephrectomy with the method of along the ureteral ascending was safe and could quickly locate and ligate the renal pedicle,and shorten operation time,reduce postoperative complications.
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<p><b>OBJECTIVE</b>To investigate the sexual development in adolescents after surgical treatment for undescended testes.</p><p><b>METHODS</b>One hundred and eighty-four adolescents undergoing surgery for cryptorchidism before the age of 10 years, 22 cases received no surgical management for unilateral undescended testes, and 25 normal controls were studied. The pubic stage, the natural length and girth of the penis, the volume of the testis, serum luteinizing hormone (LH), follicle-stimulating hormone (FSH) and testosterone (T) were examined to find out the effect of age, the location of the testis and operative procedures on prognosis.</p><p><b>RESULTS</b>The pubic stage, the length and girth of the penis, the volume of the testis and T decreased, but FSH and LH increased significantly in 18 adolescents who had undergone bilateral orchiopexy. The volume of the unilaterally undescended testis was significantly smaller than that of the normally descended contralateral gonad in 152 adolescents who had undergone unilateral orchiopexy. FSH was significantly higher in the adolescents surgically treated for unilateral cryptorchidism. Those treated by unilateral orchiectomy presented significantly higher levels of FSH than those by unilateral orchiopexy. The pubic stage, the length and girth of the penis, the volume of the testis and T were significantly higher, but FSH lower in the adolescents treated before the age of 5 years than at the age of 5 or older. The decrease in testicular volume was significantly greater in adolescents with intra-abdominal testes. Significant negative correlation was found between FSH and testicular volume.</p><p><b>CONCLUSION</b>Leydig cell function seems relatively resistant to the hostile environment of the cryptorchidism. Early diagnosis and management of the undescended testis are needed to preserve fertility.</p>
Subject(s)
Adolescent , Child , Child, Preschool , Humans , Infant , Male , Cryptorchidism , General Surgery , Follicle Stimulating Hormone , Blood , Luteinizing Hormone , Blood , Puberty , Sexual Maturation , Testosterone , BloodABSTRACT
Objective To investigate the sexual development in adolescents after surgical treatment for undescended testes. Methods A total of 166 adolescents underwent surgery for cryptorchidism before age of 10 years.They were divided into 2 groups according to surgical methods,ie,orchiectomy group and orchiopexy group;for the latter,they were subdivided into