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.

Early complications after robot-assisted laparoscopic radical cystectomy and their risk factors / 中南大学学报(医学版)

To identify risk factors for early complications in patients after robot-assisted laparoscopic radical cystectomy (RARC) and a standardized reporting model to predict complications precisely and recommend reasonable prophylaxis.
 Methods: A total of 90 patients with bladder cancer, who underwent RARC in the Second Xiangya Hospital and the Third Xiangya Hospital of Central South University from January 2016 to January 2018, were enrolled for this study. Their clinical information, preoperative examination and follow-up data within 90 d after RARC were collected. Univariable and multivariable logistic regressions were performed to identify risk factors for early complications after RARC.
 Results: The overall incidence of complications within 90 d after RARC was 48.9% (44/90), including 9 cases of Clavien grade 1, 17 cases of Clavien grade 2, 4 cases of Clavien grade 3, 12 cases of Clavien grade 4, and 2 cases of Clavien grade 5. Acute renal injury (22.2%), intestinal obstruction (16.7%), urinary tract infection (14.4%) and lymphatic leakage (10.0%) were the most common complications within 90 d after the operation. Two patients (2.2%) died within 90 d after the operation. Preoperative BMI (OR=1.16, 95% CI 1.02 to 1.32), postoperative instant (≤30 min) serum creatinine (OR=1.02, 95% CI 1.00 to 1.03), and pT stage (OR=1.67, 95% CI 1.05 to 2.68) were the risk factors for early complications after RARC. 
 Conclusion: The incidence of early complications after RARC is high. Preoperative hemodialysis, correction of anemia, intraoperative protection of renal function, and early recovery after surgery are helpful to prevent early complications after RARC.

Clinical effect of doxazosin combined with diclofenac sodium in the treatment of bladder spasm after transurethral bipolar plasmakinetic prostatectomy / 中华老年医学杂志

Objective To observe the clinical effect of doxazosin combined with diclofenac sodium in the treatment of bladder spasm after transurethral bipolar plasmakinetic prostatectomy (TUPKP).Methods 200 BPH patients undergoing TUPKP were randomly divided into 4 groups according to single-blind randomized controlled trial design:group A,group B,group C,group D (n =50,each).Patients in group A were given diclofenac sodium 100 mg,q12h,in anus after surgery and doxazosin 4 mg/d orally after anesthetic awareness.Patients in group B were given diclofenac sodium in anus 100 mg,q 12h in anus after surgery.Patients in group C were given doxazosin 4 mg/d orally after anesthetic awareness.Patients in group D were not given diclofenac sodium and doxazosin.Drugs were withdrawn 3 days after surgery.Results In group A,the average time of bladder spasm was (0.47±0.18) time,(0.35±0.16) time,(0.30±0.20) time at the 1st,2 nd,3 rd day respectively; the duration of bladder spasm was (3.2±1.5) min,(2.1±1.3) min,(1.4±1.2)min at the 1st,2nd,3th day respectively; the time of bladder perfusion clearance was (1.5± 0.3)days and the time of urethral catheter removal was (4.0±0.5) days.There were significant differences in above observed values between group D and the other groups (all P＜0.05).Conclusions Doxazosin combined with diclofenac sodium therapy is effective in the treatment of bladder spasm after bipolar transurethral plasmakinetic prostatectomy.

Mixed prostatic carcinoma: a report of 5 patients and literature review / 中南大学学报(医学版)

Objective To improve the awareness of rare mixed prostatic carcinoma. Methods We reviewed the clinical data of 5 patients with prostatic mixed tumor and relevant literature to ex-plore diagnosis and treatment for it. Results Patient 1 with mixed small cell carcinoma and adeno-carcinoma of the prostate who underwent transurethral electrovaporization of the prostate (TUVP) and flumamide therapy died of lung metastasis 7 months later. Patient 2 with mixed small cell carcinoma and adenocarcinoma of the prostate who underwent TUVP and bilateral testicular resection died of lung metastasis 10 months later. Patient 3 with adenosquamous carcinoma of the prostate who underwent TUVP, radiation therapy and flumamide therapy died of multiple organ failure 8 months later because of the lung, liver, and multiple bone metastasis. Patient 4 with prostatic adenosquamous carcinoma who underwent cystoprostatectomy combined with urinary diversion has already survived for 1 year. Patient 5 with prostatic carcinosarcoma who underwent cystoprostatectomy, urinary diversion, pelvic lymphadenectomy, and radiation therapy died of lung metastasis 13 months later. Conclusion Mixed prostatic carcinoma is quite aggressive with bad prognosis. Its diagnosis relies on detailed pathological examination and immunohistochemical techniques. Patients with prostate adenocarcinoma should be followed up timely after endocrine treatment or radiotherapy. Radical surgery is most effective for mixed prostatic carcinoma.

Treatment of bilateral hydronephrosis caused by prostate cancer / 中华泌尿外科杂志

Objective To evaluate the treatment of bilateral hydronephrosis caused by prostate cancer. Methods Twenty-four eases with mean age of 71 years old (ranging from 64--81 years old) were diagnosed with bilateral hydronephrosis caused by prostate cancer and treated with complete androgen deprivation. Surgical castration plus Bicalutamide 50 mg/d was offered to 18 eases and medical castration (Goserelin, 3. 6 mg/month) plus Bicalutamide 50 mg/d was offered to 6 cases. There were 19 cases developed severe lower urinary tract symptoms. Among these 19 cases, 13 cases had accepted Foley catheter and 6 cases accepted suprapubic tube drainage. Results Before and after the treatment, the prostate volume decreased from (70. 3±11.2)ml to (42.6±15.8)ml(P=0. 001). Total PSA decreased from (40. 3±27.2)ng/ml to (9.5±8.3)ng/ml(P=0.02). Of the 24 cases, hydrone phrosis improved in 18 cases, remained unchanged in 3 cases and deteriorated in 3 cases. There were 14 patients developed renal insufficiency. After the treatment, Serum urea nitrogen decreased from (12. 8±6. 5) mmol/L to (6. 3 ± 4. 2) mmol/L (P = 0. 004) and serum ereatinine decreased from (206.8±152.3)μmol/L to (85.3±43.6)μmol/L(P=0.03), respectively. For those 6 cases with hy dronephrosis unchanged or deteriorated during the treatment, 4 cases accepted percutaneous nephros tomy and 2 cases accepted chtaneous ureterostomy. Conclusion The combination of complete androgen deprivation and bladder drainage through Foley catheter or suprapubic tube is an effective option in the treatment of bilateral hydronephrosis caused by prostate cancer.