Spots Global Cancer Trial Database for Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer
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Trial Identification
Brief Title: Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer
Official Title: Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients
Study ID: NCT00128531
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.
Detailed Description: Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses. Study Design: This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy. A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months. 12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
Desert Oasis Cancer Center, Casa Granda, Arizona, United States
Southwest Florida Urologic Associates, Fort Myers, Florida, United States
Advanced Research Institute, Inc., New Port Richey, Florida, United States
Florida Urology Specialists, Sarasota, Florida, United States
Regional Urology, Shreveport, Louisiana, United States
Lakeside Urology, St. Joseph, Michigan, United States
Hamilton Urology, P.A., Hamilton, New Jersey, United States
Lawrenceville Urology, Lawrenceville, New Jersey, United States
AccuMed Research Associates, Garden City, New York, United States
Urological Surgeons of Long Island, Garden City, New York, United States
Hudson Valley Urology, Kingston, New York, United States
Hudson Valley Urology, Poughkeepsie, New York, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Associates, PC, Nashville, Tennessee, United States
Department of Urology, Vienna University Medical School, Vienna, , Austria
Urocentrum Praha, Prague, , Czech Republic
Urology Department, Hviezdoslavova, Prague, , Czech Republic
Charles University, Clinic of Urology, Praha, , Czech Republic
Masaryk Hospital, Urology Dept., Usti nad Labem, , Czech Republic
Department of Urology, Technical University of Dresden, Dresden, , Germany
Department of Urology, Semmelweis University, Budapest, , Hungary
Department of Urology, Medical School, University of Pécs, Pecs, , Hungary
Department of Urology, General Hospital of Bolzano, Bolzano, , Italy
Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor, Milan, , Italy
Department of Urology, Jessenius Faculty of Medicine, Comenius University, Martin, , Slovakia
Institut Català d'Oncologia, Hospital Duran I Reynals, Servicio de Oncologia Medica, Barcelona, , Spain
Royal Free Hospital and School of Medicine, London, , United Kingdom
Contact Details
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