Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

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.

Analysis of the clinical efficacy and safety of laparoscopic radical prostatectomy in prostate cancer patients aged 80 years or older / 现代泌尿外科杂志

【Objective】 To investigate the clinical efficacy and safety of laparoscopic radical prostatectomy in elderly prostate cancer patients aged ≥80 years in good health. 【Methods】 A total of 18 octogenarian patients who underwent laparoscopic radical prostatectomy during Aug.2016 and Mar.2020 at our hospital were selected for retrospective analysis. 【Results】 The patients were 80 to 86 years old. The preoperative serum PSA was 5.25-101.00 ng/mL. There were 2 cases in stage cT1N0M0,12 in stagec T2N0M0 and 4 in stage cT3N0M. The Gleason score was ≤6 in 4 cases,=7 in 9 cases,and ≥8 in 5 cases. During the follow-up of 22 to 65 months,the rates of urinary incontinence at 1 month,3 months,6 months,and 1 year were 50.00% (9/18),33.33% (6/18),16.67% (3/18) and 5.56 %(1/18),respectively. The postoperative urinary control recovery time was 1 to 220 days. Positive incision margin developed in 3 cases and biochemical recurrence occurred in 3 cases. The IPSS score at 3, 6 months and 1 year after surgery were lower than these before surgery (P<0.05). The overall health score of the FACD-P scale at 6 months after surgery was higher than that before surgery (P<0.05). 【Conclusion】 For well selected octogenarian prostate cancer patients in good condition,laparoscopic radical prostatectomy is a feasible,safe and effective treatment option,but long-term follow-up and prospective clinical studies with large sample size are still needed to confirm its efficacy.

Retroperitoneoscopic adrenalectomy in semilateral supine position / 中华泌尿外科杂志

Objective To discuss the semilateral supine position for retroperitoneoscopic adrenalectomy. Methods From Jan. 2006 to Dec. 2008, 36 patients (20 males and 16 females with mean age of 43 years) underwent retroperitoneoscopic adrenalectomy in 60° -70° semilateral supine position. There were adrenal cortex adenomas in 18 cases, pheochromocytoma in 6 cases, adrenal cysts in 3 cases, myelolipoma in 2 cases, gangliocytoma in 1 case, lymphangioma in 1 case, metastatic tumor in 1 case and corticohyporplasia in 4 cases. The mean diameter of the tumors was 2.6 cm( 0.5 - 7.7 cm ). The tumors were superior to the renal pole in 5 cases, anteromedial in 10 cases and superomedial in 17 cases. The three ports that were usually used in lateral position and were placed anteriorly to create retroperitoneal place: the first port was placed 2 -4 cm superior to the iliac crest along the anterior axillary line, the other two were placed just below the costal margin along the midaxillary line and at the same level along the midclavicular line, and dissected along the anterior surface of kidney to its superomedial aspect, so as to avoid the hampering of the kidney in the exposing of the diseased adrenal gland. Results The procedure was completed successfully in all of the cases with the operating time of 37 - 145 min ( mean 69 min) and intraoperative blood loss of 30 - 100 ml (mean 48 ml). Six cases had rupture of peritoneum, which were sutured and the procedure was continued to completion. The postoperative hospital stay was 3 -8 d (mean 5 d ). Thirty-five patients were available for follow-up of 3 - 28 months ( mean 14 months). The case of metastatic tumor died of the primary diseases in the 12th month postoperatively. No other complication was found. Conclusion With this alternative position and ports' location, the procedure of retroperitoneoscopic adrenalectomy could be easier and safer than the conventional position.