Detail of the clinical trial
| Title of the trial | An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue |
|---|---|
| EudraCT number | 2021-005719-29 |
| Protocol number | D-FR-52014-245 |
| Sponsor | Ipsen Pharma SAS,65, quai Georges Gorse ,Boulogne Billancourt,92100,France |
| Indications | Oncology |
| Diagnosis | prostate cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Patients |
| Year of receiving the request to Institute (SÚKL) | 2022 |
| Date of approval by Institute (SÚKL) | 9.6.2022 |
| Date of approval by EC | 26.8.2022 |
| Date of initiation CT in ČR | 3.1.2023 |
| Date of ending CT in ČR | |
| Notice | |
| Sites |
Fakultní nemocnice u sv. Anny v Brně,Onkologicko-chirurgické oddělení,Pekařská 53,Brno,656 91 Fakultní nemocnice Olomouc,Onkologická klinika,I. P. Pavlova 185/6,Olomouc,779 00 (discontinued) Všeobecná fakultní nemocnice v Praze,Urologická klinika VFN a 1. LF UK v Praze,Ke Karlovu 6,Praha 2,128 08 |
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