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.

Correlation between prostate volume and postoperative stress urinary incontinence after holmium laser enucleation of the prostate in the elderly benign prostatic hyperplasia patients / 中国医师进修杂志

Objective@#To investigate the relationship between prostate volume and postoperative stress urinary incontinence (SUI) in the elderly benign prostatic hyperplasia (BPH) patients following holmium laser enucleation of the prostate (HoLEP).@*Methods@#A retrospective analysis was performed on clinical data of 110 elderly (age ≥ 60 years) BPH patients who underwent HoLEP in Grand Hospital of Jincheng in Shanxi between 2014 and 2018. In these patients, preoperative transrectal ultrasonography revealed that the prostate volume was 21-198(74.53 ± 31.26) ml. According to prostate volume, the patients were allocated to large prostate volume group (prostate volume ≥ 80 ml), intermediate prostate volume group (40 ml < prostate volume < 80 ml) and small prostate volume group (prostate volume ≤ 40 ml). All patients underwent the HoLEP, the incidence of postoperative SUI was compared among the three groups after withdrawal of stenting catheters.@*Results@#After HoLEP, 74 patients were uneventful, while 36 patients experienced the postoperative SUI. No perpetual SUI patient was found after follow-up for 1 week to 6 months. The incidence of postoperative SUI after HoLEP was positively correlated with prostate volume (r=0.331, P < 0.05). The 36 elderly BPH patients with postoperative SUI accounted for 51.35%(19/37), 33.33% (12/36) and 13.51% (5/37), respectively in large, intermediate and small prostate volume groups, with statistically significant difference among three groups after Kruskal-Walls test (χ2= 11.930, P < 0.05).@*Conclusions@#The incidence of postoperative stress urinary incontinence after HoLEP of the prostate is positively correlated with prostate volume in the elderly BPH patients.

Correlation between prostate volume and postoperative stress urinary incontinence after holmium laser enucleation of the prostate in the elderly benign prostatic hyperplasia patients / 中国医师进修杂志

Objective To investigate the relationship between prostate volume and postoperative stress urinary incontinence (SUI) in the elderly benign prostatic hyperplasia (BPH) patients following holmium laser enucleation of the prostate (HoLEP). Methods A retrospective analysis was performed on clinical data of 110 elderly (age ≥60 years) BPH patients who underwent HoLEP in Grand Hospital of Jincheng in Shanxi between 2014 and 2018. In these patients, preoperative transrectal ultrasonography revealed that the prostate volume was 21-198(74.53 ± 31.26) ml. According to prostate volume, the patients were allocated to large prostate volume group (prostate volume≥80 ml) , intermediate prostate volume group (40 ml<prostate volume<80 ml) and small prostate volume group (prostate volume≤40 ml). All patients underwent the HoLEP, the incidence of postoperative SUI was compared among the three groups after withdrawal of stenting catheters. Results After HoLEP, 74 patients were uneventful, while 36 patients experienced the postoperative SUI. No perpetual SUI patient was found after follow-up for 1 week to 6 months. The incidence of postoperative SUI after HoLEP was positively correlated with prostate volume (ri0.331, P<0.05). The 36 elderly BPH patients with postoperative SUI accounted for 51.35% (19/37), 33.33% (12/36) and 13.51% (5/37), respectively in large, intermediate and small prostate volume groups, with statistically significant difference among three groups after Kruskal-Walls test (χ2 = 11.930, P < 0.05). Conclusions The incidence of postoperative stress urinary incontinence after HoLEP of the prostate is positively correlated with prostate volume in the elderly BPH patients.