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

NCT ID: NCT05458856

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2024-07-08

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triptorelin embonate

All participants will receive triptorelin embonate 22.5 mg

Group Type: EXPERIMENTAL

Triptorelin embonate 22.5 mg

Intervention Type: DRUG

A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169

Interventions

Triptorelin embonate 22.5 mg

A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169

Intervention Type: DRUG

Other Intervention Names

Decapeptyl

Eligibility Criteria

Inclusion Criteria

• Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent
• Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen deprivation therapy
• Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy).
• Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening
• Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
• Has a life expectancy of >18 months
• Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria

• Presence of another neoplastic lesion or brain metastases
• Metastatic hormone-sensitive prostate cancer with high tumour burden
• Metastatic castration-resistant prostate cancer
• Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator
• Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months
• Planned intermittent scheme of GnRH analogue
• At the time of screening, planned use of any chemotherapy for prostate cancer during the study
• Prior hypophysectomy or adrenalectomy
• Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research
• Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range)
• Any concomitant disorder or resulting therapy that is likely to interfere with participant's compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator
• Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes
• Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues
• Known active use of recreational drug or alcohol dependence in the opinion of the investigator
• Inability to give informed consent or to comply fully with the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZ Antwerpen

Edegem, , Belgium

AZGroeninge

Kortrijk, , Belgium

CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

Liège, , Belgium

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, , 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 Privé Métropole Lille - Polyclinique Du Bois

Lille, , France

CHU Hopital Edouard Herriot

Lyon, , France

L'Institut Mutualiste Montsouris

Paris, , France

Hopital Bichat

Paris, , France

Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Hopital Foch - Urologie et Transplantation Ré

Suresnes, , France

Saint Jean Languedoc and La Croix du Sud Hospital

Toulouse, , France

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

University Hospital Jena KöR

Jena, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Studienpraxis Urologie

Nürtingen, , Germany

Universität Tuebingen - Urology

Tübingen, , Germany

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, , Lithuania

Klaipeda University Hospital

Klaipėda, , Lithuania

National Cancer Institute

Vilnius, , Lithuania

Vilniaus Universiteto ligonines Santariskiu Klinikos

Vilnius, , Lithuania

The Netherlands Cancer Institute - Oncology

Amsterdam, , Netherlands

Catharina Ziekenhuis - Urology

Eindhoven, , Netherlands

CWZ

Nijmegen, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital de La Santa Creu i Sant Pau - Oncología Médica

Barcelona, , Spain

H. de Basurto - Urología

Bilbao, , Spain

POLUSA - Policlínico Lucense - Oncología

Lugo, , Spain

Hospital Universitario 12 de Octubre- Urology

Madrid, , Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, , Spain

Hospital Universitario Virgen del Rocio- Urología Pediátrica

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Countries

Belgium; Czechia; France; Germany; Lithuania; Netherlands; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2025/07/04145025/D-FR-52014-245_Lay-Summary_Final_04Jul2025.pdf

Lay language results summary

Other Identifiers

2021-005719-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D-FR-52014-245

Identifier Type: -

Identifier Source: org_study_id