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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Triptorelin embonate 22.5 mg

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Cliniques Universitaires Saint-Luc
  • Edegem, Belgium
    • UZ Antwerpen
  • Kortrijk, Belgium, 8500
    • AZGroeninge
• Czechia
  • Brno, Czechia
    • Fakultni nemocnice u sv. Anny v Brne
  • Olomouc, Czechia
    • Fakultní Nemocnice Olomouc
  • Praha, Czechia
    • Vseobecna fakultni nemocnice v Praze
• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire D'Angers - Urologie
  • Brest, France, 29200
    • CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
  • Brest, France, 29229
    • Clinique Pasteur-Lanroze - Oncology
  • La Chaussée-Saint-Victor, France, 41260
    • Polyclinique de Blois - Service oncologie
  • Lille, France, 59000
    • Hopital Privé Métropole Lille - Polyclinique Du Bois
  • Lyon, France, 69437
    • CHU Hopital Edouard Herriot
  • Paris, France, 75018
    • Hopital Bichat
  • Paris, France, 75014
    • L'Institut Mutualiste Montsouris
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Suresnes, France, 92151
    • Hopital Foch - Urologie et Transplantation Ré
  • Toulouse, France, 31400
    • Saint Jean Languedoc and La Croix du Sud Hospital
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus
  • Jena, Germany
    • University Hospital Jena KöR
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie
  • Tuebingen, Germany
    • Universität Tuebingen - Urology
• Lithuania
  • Kaunas, Lithuania
    • Hospital of Lithuanian University of Health Sciences Kaunas
  • Klaipėda, Lithuania, LT92288
    • Klaipeda university hospital
  • Vilnius, Lithuania, LT-08660
    • National Cancer Institute
  • Vilnius, Lithuania
    • Vilniaus Universiteto ligonines Santariskiu Klinikos
• Netherlands
  • Amsterdam, Netherlands
    • The Netherlands Cancer Institute - Oncology
  • Den Haag, Netherlands
    • Haga Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis - Urology
  • Nijmegen, Netherlands, 6532 SZ
    • CWZ
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de La Santa Creu i Sant Pau - Oncología Médica
  • Bilbao, Spain, 48013
    • H. de Basurto - Urología
  • Lugo, Spain, 27004
    • POLUSA - Policlínico Lucense - Oncología
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre- Urology
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias (HUCA)
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio- Urología Pediátrica
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triptorelin embonate; All participants will receive triptorelin embonate 22.5 mg	Drug: 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; Other Names: Decapeptyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 29
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 85
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 141
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 169
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 253
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 309
Percentage of participants maintaining castrate levels of serum testosterone	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.	At day 337

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants castrated	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)).	Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337
Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL)		From baseline to Week 52
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
Percentage of participants castrated	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)).	Day 3 and Day 7 after each injection administered on Day 1 and Day 169
Percent change in Prostate Specific Antigen	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.	Baseline, Day 169 and Day 337
Incidence of treatment-emergent adverse events (including local tolerability)	All adverse events and serious adverse events will be collected from the signing of the informed consent form until the end of the study.	Up to Day 337
Change in clinical safety laboratory blood chemistry parameters	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.	Baseline and Day 337
Change in clinical safety laboratory haematology parameters	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.	Baseline and Day 337
Change in physical examination	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.	Baseline, Day 169, and Day 337
Change in electrocardiogram (ECG)	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.	Baseline and Day 337
Change in heart rate	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.	Baseline and at each visit up to Day 337
Change in blood pressure	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.	Baseline and at each visit up to Day 337

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): July 12, 2024
• Study Completion (Estimated): July 12, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: D-FR-52014-245; 2021-005719-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing 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.
• IPD Sharing 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/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes