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

NCT05458856 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: D-FR-52014-2452021-005719-29
• Study Type: interventional
• Target: 147
• Locations: 7 countries
• Sites: 39

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study

  Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \<1.735 nanomoles per liter (nmol/L) (\<50 nanograms/deciliter \[ng/dL\]) at Days 29, 85, 141, 169, 253, 309 and 337.

  Up to Day 337

Secondary Outcomes (6)

• Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337

  Days 29, 85, 141, 169, 253, 309 and 337

• Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study

  Up to Day 337

• Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337

  Days 29, 85, 141, 169, 253, 309 and 337

• Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169

  On Days 3, 7, 171, and 175

• Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337

  Baseline (prior to injection on Day 1), Days 169 and 337

Study Arms (1)

Triptorelin embonate

EXPERIMENTAL

All participants will receive triptorelin embonate 22.5 mg

Drug: Triptorelin embonate 22.5 mg

Interventions

Triptorelin embonate 22.5 mg 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

Also known as: Decapeptyl

Triptorelin embonate

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant is male as indication is prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (39)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

AZGroeninge

Kortrijk, 8500, Belgium

Location

CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

Liège, Belgium

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, Czechia

Location

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Location

Centre Hospitalier Universitaire D'Angers - Urologie

Angers, 49933, France

Location

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

Brest, 29200, France

Location

Clinique Pasteur-Lanroze - Oncology

Brest, 29229, France

Location

Polyclinique de Blois - Service oncologie

La Chaussée-Saint-Victor, 41260, France

Location

Hopital Privé Métropole Lille - Polyclinique Du Bois

Lille, 59000, France

Location

CHU Hopital Edouard Herriot

Lyon, 69437, France

Location

L'Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Bichat

Paris, 75018, France

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Foch - Urologie et Transplantation Ré

Suresnes, 92151, France

Location

Saint Jean Languedoc and La Croix du Sud Hospital

Toulouse, 31400, France

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

University Hospital Jena KöR

Jena, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Studienpraxis Urologie

Nürtingen, 72622, Germany

Location

Universität Tuebingen - Urology

Tübingen, Germany

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, Lithuania

Location

Klaipeda University Hospital

Klaipėda, LT92288, Lithuania

Location

National Cancer Institute

Vilnius, LT-08660, Lithuania

Location

Vilniaus Universiteto ligonines Santariskiu Klinikos

Vilnius, Lithuania

Location

The Netherlands Cancer Institute - Oncology

Amsterdam, Netherlands

Location

Catharina Ziekenhuis - Urology

Eindhoven, 5623 EJ, Netherlands

Location

CWZ

Nijmegen, 6532 SZ, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu i Sant Pau - Oncología Médica

Barcelona, 08041, Spain

Location

H. de Basurto - Urología

Bilbao, 48013, Spain

Location

POLUSA - Policlínico Lucense - Oncología

Lugo, 27004, Spain

Location

Hospital Universitario 12 de Octubre- Urology

Madrid, 28041, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, 33011, Spain

Location

Hospital Universitario Virgen del Rocio- Urología Pediátrica

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Related Links

• Lay language results summary

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 14, 2022
• Study Start: August 30, 2022
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: July 25, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

DE (5); NL (4); FR (11); LI (4); ES (8); BE (4); CZ (3)