Spots Global Cancer Trial Database for Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
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Trial Identification
Brief Title: Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
Official Title: An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
Study ID: NCT03261999
Conditions
Interventions
Study Description
Brief Summary: The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
Detailed Description: This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
Arizona Institute of Urology, Tucson, Arizona, United States
The Urology Center of Colorado, Denver, Colorado, United States
Carolina Clinical Trials, LLC, Concord, North Carolina, United States
Urology San Antonio, P.A, San Antonio, Texas, United States
Urology of Virginia, PLLC, Virginia Beach, Virginia, United States
Fakultní nemocnice Hradec Králové, Urologická klinika, Hradec Králové, , Czechia
Uromedical Center Olomouc, Olomouc, , Czechia
Thomayerova nemocnice, Urologické oddělení, Praha, , Czechia
Pusan National University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hosptal, Gyeonggi-do, , Korea, Republic of
Hallym University Sacred Heart Hospital, Gyeonggi-do, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas, , Lithuania
Klaipėda University Hospital, Klaipėda, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Vilnius University Hospital, Santaros klinikos, Vilnius, , Lithuania
UROCENTRUM MILAB, s.r.o., Prešov, , Slovakia
Fakultná nemocnica s poliklinikou Žilina Urológia, Žilina, , Slovakia
Contact Details
Name: John Mao, PhD
Affiliation: Foresee Pharmaceuticals Co., Ltd.
Role: STUDY_DIRECTOR
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