Clinical trial NCT05458856: Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 147
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 29
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 85
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 141
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 169
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 253
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 309
measure: Percentage of participants maintaining castrate levels of serum testosterone
timeFrame: At day 337
Secondary outcomes:
measure: Percentage of participants castrated
timeFrame: Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337
measure: Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL)
timeFrame: From baseline to Week 52
measure: Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL)
timeFrame: Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337
measure: Percentage of participants castrated
timeFrame: Day 3 and Day 7 after each injection administered on Day 1 and Day 169
measure: Percent change in Prostate Specific Antigen
timeFrame: Baseline, Day 169 and Day 337
measure: Incidence of treatment-emergent adverse events (including local tolerability)
timeFrame: Up to Day 337
measure: Change in clinical safety laboratory blood chemistry parameters
timeFrame: Baseline and Day 337
measure: Change in clinical safety laboratory haematology parameters
timeFrame: Baseline and Day 337
measure: Change in physical examination
timeFrame: Baseline, Day 169, and Day 337
measure: Change in electrocardiogram (ECG)
timeFrame: Baseline and Day 337
measure: Change in heart rate
timeFrame: Baseline and at each visit up to Day 337
measure: Change in blood pressure
timeFrame: Baseline and at each visit up to Day 337
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Kortrijk
country: Belgium
facility: AZGroeninge
city: Liège
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers - Urologie
city: Brest
country: France
facility: CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
city: Brest
country: France
facility: Clinique Pasteur-Lanroze - Oncology
city: La Chaussée-Saint-Victor
country: France
facility: Polyclinique de Blois - Service oncologie
city: Lille
country: France
facility: Hopital Privé Métropole Lille - Polyclinique Du Bois
city: Lyon
country: France
facility: CHU Hopital Edouard Herriot
city: Paris
country: France
facility: L'Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hopital Bichat
city: Pierre-Bénite
country: France
facility: Centre hospitalier Lyon Sud
city: Suresnes
country: France
facility: Hopital Foch - Urologie et Transplantation Ré
city: Toulouse
country: France
facility: Saint Jean Languedoc and La Croix du Sud Hospital
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Jena
country: Germany
facility: University Hospital Jena KöR
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
city: Tuebingen
country: Germany
facility: Universität Tuebingen - Urology
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas
city: Klaipėda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto ligonines Santariskiu Klinikos
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute - Oncology
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis - Urology
city: Nijmegen
country: Netherlands
facility: CWZ
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau - Oncología Médica
city: Bilbao
country: Spain
facility: H. de Basurto - Urología
city: Lugo
country: Spain
facility: POLUSA - Policlínico Lucense - Oncología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre- Urology
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio- Urología Pediátrica
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: