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

Prostate Cancer Clinical Trial

— TriptoSwitch  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05458856
• Other study ID #: D-FR-52014-245
• Secondary ID: 2021-005719-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 30, 2022
• Est. completion date: July 12, 2024

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147
• Est. completion date: July 12, 2024
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	AZGroeninge	Kortrijk
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Vseobecna Fakultni Nemocnice V Praze	Praha
France	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	Hopital Bichat	Paris
France	L'Institut Mutualiste Montsouris	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
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	University Hospital Jena KöR	Jena
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Studienpraxis Urologie	Nürtingen
Germany	Universität Tuebingen - Urology	Tuebingen
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilniaus Universiteto ligonines Santariskiu Klinikos	Vilnius
Netherlands	The Netherlands Cancer Institute - Oncology	Amsterdam
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Catharina Ziekenhuis - Urology	Eindhoven
Netherlands	CWZ	Nijmegen
Spain	Hospital de La Santa Creu i Sant Pau - Oncología Médica	Barcelona
Spain	Hospital Universitario Vall d'Hebron	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	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Lithuania,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL)		From baseline to Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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