Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
- Registration Number
- NCT05458856
- Lead Sponsor
- Ipsen
- Brief Summary
The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triptorelin embonate Triptorelin embonate 22.5 mg All participants will receive triptorelin embonate 22.5 mg
- Primary Outcome Measures
Name Time Method Percentage of participants maintaining castrate levels of serum testosterone At day 337 The percentage of participants remaining castrated (maintenance of castration defined as testosterone \<1.735 nmol/L (50 ng/dL) at Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337) during the study.
- Secondary Outcome Measures
Name Time Method Percent change in Prostate Specific Antigen Baseline, Day 169 and Day 337 Defined as the absolute value of difference between the PSA values at each timepoint and the baseline value divided by the baseline value. Blood samples will be analysed to determine concentrations of PSA.
Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL) From baseline to Week 52 Change in physical examination Baseline, Day 169, and Day 337 Number of abnormal physical examination (cardiovascular, respiratory, gastrointestinal and neurological systems, Height and weight) including those that worsen from baseline and if clinically significant by investigator's judgment.
Change in blood pressure Baseline and at each visit up to Day 337 Blood pressure will be assessed with an automated device so that measurements are independent of the observer. Blood pressure will be recorded after 5 minutes rest in supine position. Absolute values and change from Baseline will be analysed.
Percentage of participants castrated Day 3 and Day 7 after each injection administered on Day 1 and Day 169 Serum will be analysed to determine concentrations of testosterone using a validated, specific and sensitive liquid chromatography tandem mass spectrometry methods. Castration defined as testosterone \<1.735 nmol/L (50 ng/dL)).
Incidence of treatment-emergent adverse events (including local tolerability) Up to Day 337 All adverse events and serious adverse events will be collected from the signing of the informed consent form until the end of the study.
Change in clinical safety laboratory haematology parameters Baseline and Day 337 Number of abnormal laboratory parameters (WBC and differential count, platelet count, Hb) or other safety assessments, including those that worsen from baseline and if clinically significant by investigator's judgment.
Change in electrocardiogram (ECG) Baseline and Day 337 A single 12-lead ECG will be recorded so that the different ECG intervals (RR, PR, QRS, QT, QTcF) can be measured automatically. The ECG will be recorded with the participant in supine position after five minutes of rest until four regular consecutive complexes are available.
Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL) Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337 Change in heart rate Baseline and at each visit up to Day 337 Heart rate will be assessed with an automated device so that measurements are independent of the observer. Heart rate will be recorded after 5 minutes rest in supine position. Absolute values and change from Baseline will be analysed.
Change in clinical safety laboratory blood chemistry parameters Baseline and Day 337 Number of abnormal laboratory parameters (creatinine, glucose, ALT, AST, alkaline phosphatase, total and conjugated bilirubin) or other safety assessments, including those that worsen from baseline and if clinically significant by investigator's judgment.
Trial Locations
- Locations (39)
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
🇧🇪Liège, Belgium
AZGroeninge
🇧🇪Kortrijk, Belgium
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, Czechia
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Centre Hospitalier Universitaire D'Angers - Urologie
🇫🇷Angers, France
CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
🇫🇷Brest, France
Clinique Pasteur-Lanroze - Oncology
🇫🇷Brest, France
Polyclinique de Blois - Service oncologie
🇫🇷La Chaussée-Saint-Victor, France
Hopital Foch - Urologie et Transplantation Ré
🇫🇷Suresnes, France
L'Institut Mutualiste Montsouris
🇫🇷Paris, France
CHU Hopital Edouard Herriot
🇫🇷Lyon, France
Hopital Privé Métropole Lille - Polyclinique Du Bois
🇫🇷Lille, France
Hopital Bichat
🇫🇷Paris, France
Centre hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Saint Jean Languedoc and La Croix du Sud Hospital
🇫🇷Toulouse, France
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Studienpraxis Urologie
🇩🇪Nürtingen, Germany
University Hospital Jena KöR
🇩🇪Jena, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Universität Tuebingen - Urology
🇩🇪Tuebingen, Germany
Klaipeda University Hospital
🇱🇹Klaipėda, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
🇱🇹Kaunas, Lithuania
National Cancer Institute
🇱🇹Vilnius, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Hospital Universitario 12 de Octubre- Urology
🇪🇸Madrid, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de La Santa Creu i Sant Pau - Oncología Médica
🇪🇸Barcelona, Spain
Catharina Ziekenhuis - Urology
🇳🇱Eindhoven, Netherlands
CWZ
🇳🇱Nijmegen, Netherlands
The Netherlands Cancer Institute - Oncology
🇳🇱Amsterdam, Netherlands
Haga Ziekenhuis
🇳🇱Den Haag, Netherlands
H. de Basurto - Urología
🇪🇸Bilbao, Spain
POLUSA - Policlínico Lucense - Oncología
🇪🇸Lugo, Spain
Hospital Universitario Central de Asturias (HUCA)
🇪🇸Oviedo, Spain
Hospital Universitario Virgen del Rocio- Urología Pediátrica
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain