1.Progress in researches on drugs for prostate cancer.
Ling-Yan CAO ; He HUANG ; Jiang-Hong NI
National Journal of Andrology 2003;9(9):703-706
In the recent years, researches on drugs for prostate cancer have received more attention than ever before. This article reviews the mechanism and efficacy of such prostate cancer drugs as bicalutamide, medroxyprogesterone acetate, megestrol acetate, flutamide and so on, as well as the clinical data and clinical uses of calcitriol analogue EB1089, SR233377, etc.
Androgen Antagonists
;
therapeutic use
;
Antineoplastic Agents
;
therapeutic use
;
Goserelin
;
therapeutic use
;
Humans
;
Male
;
Prostatic Neoplasms
;
drug therapy
;
Sulfonamides
;
therapeutic use
;
Suramin
;
therapeutic use
;
Thioxanthenes
;
therapeutic use
2.Comparison of Clinical Efficacy between a Single Administration of Long-Acting Gonadotrophin-Releasing Hormone Agonist (GnRHa) and Daily Administrations of Short-Acting GnRHa in In Vitro Fertilization-Embryo Transfer Cycles.
Kang Woo CHEON ; Sang Jin SONG ; Bum Chae CHOI ; Seung Chul LEE ; Hong Bok LEE ; Seung Youn YU ; Keun Jai YOO
Journal of Korean Medical Science 2008;23(4):662-666
This study was aimed to evaluate the efficacy of a single administration of long-acting gonadotrophin-releasing hormone agonist (GnRHa) as compared with daily administrations of short-acting GnRHa in controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) cycles. The mean dosage of recombinant follicle-stimulating hormone (rFSH) required for COH (2,354.5+/-244.2 vs. 2,012.5+/-626.1 IU) and the rFSH dosage per retrieved oocyte (336.7+/-230.4 vs. 292.1+/-540.4 IU) were significantly higher in the long-acting GnRHa group (N= 22) than those in the short-acting GnRHa group (N=28) (p<0.05). However, the mean number of visit to the hospital that was required before ovum pick-up (3.3+/-0.5 vs. 22.2+/-2.0) and the frequency of injecting GnRHa and rFSH (12.8+/-1.2 vs. 33.5+/- 3.5) were significantly decreased in the long-acting GnRHa group (p<0.0001). The clinical pregnancy rate, implantation rate, and early pregnancy loss rate were not significantly different between the 2 groups. So, we suggest that a single administration of long-acting GnRHa is a useful alternative for improving patient's convenience with clinical outcomes comparable to daily administrations of short-acting GnRHa in COH for IVF-ET cycles.
Adult
;
Buserelin/*therapeutic use
;
*Embryo Transfer
;
Female
;
*Fertilization in Vitro
;
Follicle Stimulating Hormone/therapeutic use
;
Goserelin/therapeutic use
;
Humans
;
Leuprolide/*therapeutic use
3.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
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
4.Efficacy and safety investigation of Kuntai capsule for the add-back therapy of gonadotropin releasing hormone agonist administration to endometriosis patients: a randomized, double-blind, blank- and tibolone-controlled study.
Ji-Ming CHEN ; Hong-Yan GAO ; Yi DING ; Xia YUAN ; Qing WANG ; Qin LI ; Guo-Hua JIANG
Chinese Medical Journal 2015;128(4):427-432
BACKGROUNDAs a Chinese Traditional Medicine product, Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women. But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist (GnRH-a) treatment. The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule, on peri-menopausal symptoms in endometriosis (EMS) patients, with postoperative GnRH-a treatment.
METHODSNinety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study, and were randomly divided into Kuntai group, Tibolone group, or blank Control group. The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first GnRH-a injection, while Tibolone 2.5 mg qd, po for 12 weeks in Tibolone group. There was no drug addition in Control group. Climacteric complaints were evaluated by Kupperman menopausal index (KMI) and hot flash/sweating score. Liver and renal functions, lipid profile, serum sex hormone levels and endometrial thickness were measured, and the frequency of adverse events in Kuntai and Tibolone groups was recorded.
RESULTS(1) Before GnRH-a therapy, the baseline parameter results were comparable in the three groups (P > 0.05). (2) After GnRH-a therapy, KMI and hot flash/sweating scores in all the three groups increased significantly (P < 0.05). At the 4 th week after GnRH-a therapy, KMI and hot flash/sweating score results were as follows: Control group > Kuntai group > Tibolone group (P < 0.05); at the 8 th and 12 th week after GnRH-a therapy, KMI and hot flash/sweating score in Control group were significantly higher than the other two groups (P < 0.05), and no significant difference was identified between Kuntai and Tibolone group (P > 0.05). (3) No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment (P > 0.05). (4) The posttherapeutic serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness decreased significantly in all the three groups (P < 0.05). After therapy, serum E2 level in Tibolone group was obviously higher than the other two groups (P < 0.05), while FSH and LH levels were obviously lower (P < 0.05). (5) The incidence of vaginal bleeding, breast distending pain in Tibolne group was obviously higher than Kuntai group (P < 0. 05).
CONCLUSIONSKuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients, although its clinical effect might be a few weeks later than Tibolone. Kuntai capsule might be a little safer than Tibolone tablet.
Adult ; Double-Blind Method ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Endometriosis ; drug therapy ; Endometrium ; drug effects ; pathology ; Female ; Gonadotropin-Releasing Hormone ; agonists ; Goserelin ; therapeutic use ; Humans ; Norpregnenes ; therapeutic use ; Young Adult
5.Management of thrombotic thrombocytopenic purpura in metastatic prostate cancer with only endocrine therapy.
Ravindran KANESVARAN ; Colin PHIPPS ; Christopher W S CHENG ; Michelle M F CHAN ; Daphne KHOO ; Min Han TAN
Annals of the Academy of Medicine, Singapore 2010;39(7):580-582
Androgen Antagonists
;
therapeutic use
;
Anilides
;
therapeutic use
;
Antineoplastic Agents, Hormonal
;
therapeutic use
;
Bone Neoplasms
;
complications
;
secondary
;
Goserelin
;
therapeutic use
;
Humans
;
Male
;
Middle Aged
;
Nitriles
;
therapeutic use
;
Prostatic Neoplasms
;
complications
;
drug therapy
;
Purpura, Thrombotic Thrombocytopenic
;
drug therapy
;
etiology
;
Tosyl Compounds
;
therapeutic use
6.Neoadjuvant hormonal deprivation for patients undergoing radical prostatectomy.
Xu GAO ; Tie ZHOU ; Yuan-Jie TANG ; Xin LU ; Ying-Hao SUN
Asian Journal of Andrology 2009;11(1):127-130
The purpose of this study is to evaluate the therapeutic effect of radical prostatectomy combined with preoperative neoadjuvant hormonal ablation therapy for prostate cancer (PCa). In this study, a total of 31 patients with local PCa underwent radical prostatectomy; of these, 12 patients underwent preoperative hormonal deprivation with a combination of goserelin and flutamide for a period of 5.6 months. Data regarding clinical characteristics were compared between the neoadjuvant therapy and radical prostatectomy groups. A total of 31 patients received pelvic lymph node clearance, and the rate of positive lymph nodes was 12.9% (4/31). Serum prostate-specific antigen (PSA) was 8.9 +/- 1.2 microg L(-1) after the neoadjuvant therapy and 0.4 +/- 0.3 microg L(-1) one month after the radical prostatectomy. There were significant differences in the positive surgical margins, seminal vesicle invasion and lymph node metastasis between the neoadjuvant therapy group (n = 12) and the radical prostatectomy group (n = 19, P < 0.01). The resulsts indicates that preoperative hormonal deprivation induced by goserelin and flutamide can decrease clinical and pathological staging, but assessment of its influence on long-term prognosis requires further study.
Aged
;
Antineoplastic Agents, Hormonal
;
therapeutic use
;
Combined Modality Therapy
;
Dose-Response Relationship, Drug
;
Flutamide
;
therapeutic use
;
Goserelin
;
therapeutic use
;
Humans
;
Male
;
Middle Aged
;
Neoadjuvant Therapy
;
methods
;
Prostate-Specific Antigen
;
blood
;
Prostatectomy
;
methods
;
Prostatic Neoplasms
;
blood
;
drug therapy
;
surgery
;
Retrospective Studies
;
Treatment Outcome
7.Clinical efficacy of integrated traditional Chinese and Western medicine for castration-resistant prostate cancer.
Yang ZHANG ; Bo-Han LEI ; Qing ZOU ; Qing-Yi ZHU ; Zi-Jie LU ; Yue WANG
National Journal of Andrology 2017;23(10):922-927
Objective:
To investigate the clinical effects of integrated traditional Chinese and Western medicine in the treatment of castration-resistant prostate cancer (CRPC).
METHODS:
A total of 54 CRPC patients were randomly divided into a control and a trial group, all treated by endocrine therapy (oral Bicalutamide at 50 mg per d plus subcutaneous injection of Goserelin at 3.6 mg once every 4 wk) and chemotherapy (intravenous injection of Docetaxel at 75 mg/m2 once every 3 wk plus oral Prednisone at 5 mg bid), while the latter group by Fuyang Huayu Prescription (a Traditional Chinese Medicine [TCM] prescription for tonifying yang and dispersing blood stasis) in addition, for a course of 24 weeks. Comparisons were made between the two groups of patients in the level of serum prostate-specific antigen (PSA), Karnofsky physical condition scores, function assessment of cancer therapy-prostate (FACT-P) scores, and TCM symptoms scores before and after 12 or 24 weeks of treatment.
RESULTS:
Compared with the baseline, the serum PSA level was significantly decreased after 12 weeks of treatment both in the control ([25.9 ± 39.3] vs [20.0 ± 21.1] μg/L, P <0.05) and in the trial group ([22.1 ± 33.9] vs [17.9 ± 19.1] μg/L, P <0.05), with no statistically significant differences between the two groups (P >0.05). At 24 weeks, however, the PSA levels in the control and trial groups were slightly increased to (23.1 ± 28.4) and (19.6 ± 23.5) μg/L, respectively, with no statistically significant differences in between (P >0.05). Karnofsky, FACT-P and TCM symptoms scores were all markedly improved in the trial group after 12 weeks of treatment (P <0.05) and remained stable at 24 weeks, but not in the control group either at 12 or at 24 weeks (P >0.05).
CONCLUSIONS
TCM Fuyang Huayu Prescription combined with endocrine therapy and chemotherapy is effective for CRPC.
Anilides
;
administration & dosage
;
Antineoplastic Agents, Hormonal
;
therapeutic use
;
Antineoplastic Combined Chemotherapy Protocols
;
therapeutic use
;
Docetaxel
;
Drug Administration Schedule
;
Goserelin
;
administration & dosage
;
Humans
;
Male
;
Nitriles
;
administration & dosage
;
Prednisone
;
administration & dosage
;
Prostate-Specific Antigen
;
blood
;
Prostatic Neoplasms, Castration-Resistant
;
blood
;
drug therapy
;
Taxoids
;
administration & dosage
;
Tosyl Compounds
;
administration & dosage
;
Treatment Outcome