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Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Triptorelin embonateTriptorelin embonate 22.5 mgAll participants will receive triptorelin embonate 22.5 mg
Primary Outcome Measures
NameTimeMethod
Percentage of participants maintaining castrate levels of serum testosteroneAt 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
NameTimeMethod
Percent change in Prostate Specific AntigenBaseline, 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 examinationBaseline, 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 pressureBaseline 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 castratedDay 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 parametersBaseline 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 rateBaseline 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 parametersBaseline 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

πŸ‡§πŸ‡ͺ

Bruxelles, Belgium

UZ Antwerpen

πŸ‡§πŸ‡ͺ

Edegem, Belgium

CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

πŸ‡§πŸ‡ͺ

Liège, Belgium

AZGroeninge

πŸ‡§πŸ‡ͺ

Kortrijk, Belgium

Fakultni nemocnice Olomouc

πŸ‡¨πŸ‡Ώ

Olomouc, Czechia

Vseobecna Fakultni Nemocnice V Praze

πŸ‡¨πŸ‡Ώ

Praha, Czechia

Fakultni nemocnice u sv. Anny v Brne

πŸ‡¨πŸ‡Ώ

Brno, Czechia

Centre Hospitalier Universitaire D'Angers - Urologie

πŸ‡«πŸ‡·

Angers, France

CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat

πŸ‡«πŸ‡·

Brest, France

Clinique Pasteur-Lanroze - Oncology

πŸ‡«πŸ‡·

Brest, France

Polyclinique de Blois - Service oncologie

πŸ‡«πŸ‡·

La ChaussΓ©e-Saint-Victor, France

Hopital Foch - Urologie et Transplantation RΓ©

πŸ‡«πŸ‡·

Suresnes, France

L'Institut Mutualiste Montsouris

πŸ‡«πŸ‡·

Paris, France

CHU Hopital Edouard Herriot

πŸ‡«πŸ‡·

Lyon, France

Hopital PrivΓ© MΓ©tropole Lille - Polyclinique Du Bois

πŸ‡«πŸ‡·

Lille, France

Hopital Bichat

πŸ‡«πŸ‡·

Paris, France

Centre hospitalier Lyon Sud

πŸ‡«πŸ‡·

Pierre-BΓ©nite, France

Saint Jean Languedoc and La Croix du Sud Hospital

πŸ‡«πŸ‡·

Toulouse, France

UniversitΓ€tsklinikum Carl Gustav Carus

πŸ‡©πŸ‡ͺ

Dresden, Germany

Studienpraxis Urologie

πŸ‡©πŸ‡ͺ

NΓΌrtingen, Germany

University Hospital Jena KΓΆR

πŸ‡©πŸ‡ͺ

Jena, Germany

Universitaetsklinikum Muenster

πŸ‡©πŸ‡ͺ

Muenster, Germany

UniversitΓ€t Tuebingen - Urology

πŸ‡©πŸ‡ͺ

Tuebingen, Germany

Klaipeda University Hospital

πŸ‡±πŸ‡Ή

KlaipΔ—da, Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas

πŸ‡±πŸ‡Ή

Kaunas, Lithuania

National Cancer Institute

πŸ‡±πŸ‡Ή

Vilnius, Lithuania

Vilniaus Universiteto ligonines Santariskiu Klinikos

πŸ‡±πŸ‡Ή

Vilnius, Lithuania

Hospital Universitario 12 de Octubre- Urology

πŸ‡ͺπŸ‡Έ

Madrid, Spain

Hospital Universitario Vall d'Hebron

πŸ‡ͺπŸ‡Έ

Barcelona, Spain

Hospital de La Santa Creu i Sant Pau - OncologΓ­a MΓ©dica

πŸ‡ͺπŸ‡Έ

Barcelona, Spain

Catharina Ziekenhuis - Urology

πŸ‡³πŸ‡±

Eindhoven, Netherlands

CWZ

πŸ‡³πŸ‡±

Nijmegen, Netherlands

The Netherlands Cancer Institute - Oncology

πŸ‡³πŸ‡±

Amsterdam, Netherlands

Haga Ziekenhuis

πŸ‡³πŸ‡±

Den Haag, Netherlands

H. de Basurto - UrologΓ­a

πŸ‡ͺπŸ‡Έ

Bilbao, Spain

POLUSA - PoliclΓ­nico Lucense - OncologΓ­a

πŸ‡ͺπŸ‡Έ

Lugo, Spain

Hospital Universitario Central de Asturias (HUCA)

πŸ‡ͺπŸ‡Έ

Oviedo, Spain

Hospital Universitario Virgen del Rocio- UrologΓ­a PediΓ‘trica

πŸ‡ͺπŸ‡Έ

Sevilla, Spain

Hospital Universitari i Politecnic La Fe

πŸ‡ͺπŸ‡Έ

Valencia, Spain

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