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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Triptorelin embonate 22.5 mg
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • UZ Antwerpen
  • AZGroeninge
  • Fakultni nemocnice u sv. Anny v Brne
  • Fakultni nemocnice Olomouc
  • Vseobecna Fakultni Nemocnice V Praze
  • Centre Hospitalier Universitaire D'Angers - Urologie
  • CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
  • Clinique Pasteur-Lanroze - Oncology
  • Polyclinique de Blois - Service oncologie
  • Hopital Privé Métropole Lille - Polyclinique Du Bois
  • CHU Hopital Edouard Herriot
  • L'Institut Mutualiste Montsouris
  • Hopital Bichat
  • Centre hospitalier Lyon Sud
  • Hopital Foch - Urologie et Transplantation Ré
  • Saint Jean Languedoc and La Croix du Sud Hospital
  • Universitätsklinikum Carl Gustav Carus
  • University Hospital Jena KöR
  • Universitaetsklinikum Muenster
  • Studienpraxis Urologie
  • Universität Tuebingen - Urology
  • Hospital of Lithuanian University of Health Sciences Kaunas
  • Klaipeda University Hospital
  • National Cancer Institute
  • Vilniaus Universiteto ligonines Santariskiu Klinikos
  • The Netherlands Cancer Institute - Oncology
  • Haga Ziekenhuis
  • Catharina Ziekenhuis - Urology
  • CWZ
  • Hospital Universitario Vall d'Hebron
  • Hospital de La Santa Creu i Sant Pau - Oncología Médica
  • H. de Basurto - Urología
  • POLUSA - Policlínico Lucense - Oncología
  • Hospital Universitario 12 de Octubre- Urology
  • Hospital Universitario Central de Asturias (HUCA)
  • Hospital Universitario Virgen del Rocio- Urología Pediátrica
  • Hospital Universitari i Politecnic La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triptorelin embonate

Arm Description

All participants will receive triptorelin embonate 22.5 mg

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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)).
Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL)
Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL)
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)).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 17, 2022
Last Updated
September 29, 2023
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT05458856
Brief Title
Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
July 12, 2024 (Anticipated)
Study Completion Date
July 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triptorelin embonate
Arm Type
Experimental
Arm Description
All participants will receive triptorelin embonate 22.5 mg
Intervention Type
Drug
Intervention Name(s)
Triptorelin embonate 22.5 mg
Other Intervention Name(s)
Decapeptyl
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 29
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 85
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 141
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 169
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 253
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 309
Title
Percentage of participants maintaining castrate levels of serum testosterone
Description
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.
Time Frame
At day 337
Secondary Outcome Measure Information:
Title
Percentage of participants castrated
Description
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)).
Time Frame
Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337
Title
Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL)
Time Frame
From baseline to Week 52
Title
Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL)
Time Frame
Day 29, Day 85, Day 141, Day 169, Day 253, Day 309, Day 337
Title
Percentage of participants castrated
Description
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)).
Time Frame
Day 3 and Day 7 after each injection administered on Day 1 and Day 169
Title
Percent change in Prostate Specific Antigen
Description
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.
Time Frame
Baseline, Day 169 and Day 337
Title
Incidence of treatment-emergent adverse events (including local tolerability)
Description
All adverse events and serious adverse events will be collected from the signing of the informed consent form until the end of the study.
Time Frame
Up to Day 337
Title
Change in clinical safety laboratory blood chemistry parameters
Description
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.
Time Frame
Baseline and Day 337
Title
Change in clinical safety laboratory haematology parameters
Description
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.
Time Frame
Baseline and Day 337
Title
Change in physical examination
Description
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.
Time Frame
Baseline, Day 169, and Day 337
Title
Change in electrocardiogram (ECG)
Description
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.
Time Frame
Baseline and Day 337
Title
Change in heart rate
Description
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.
Time Frame
Baseline and at each visit up to Day 337
Title
Change in blood pressure
Description
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.
Time Frame
Baseline and at each visit up to Day 337

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participant is male as indication is prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
Country
Belgium
Facility Name
AZGroeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Praha
Country
Czechia
Facility Name
Centre Hospitalier Universitaire D'Angers - Urologie
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Clinique Pasteur-Lanroze - Oncology
City
Brest
ZIP/Postal Code
29229
Country
France
Facility Name
Polyclinique de Blois - Service oncologie
City
La Chaussée-Saint-Victor
ZIP/Postal Code
41260
Country
France
Facility Name
Hopital Privé Métropole Lille - Polyclinique Du Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
L'Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Foch - Urologie et Transplantation Ré
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Saint Jean Languedoc and La Croix du Sud Hospital
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Hospital Jena KöR
City
Jena
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universität Tuebingen - Urology
City
Tuebingen
Country
Germany
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipėda
ZIP/Postal Code
LT92288
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Vilniaus Universiteto ligonines Santariskiu Klinikos
City
Vilnius
Country
Lithuania
Facility Name
The Netherlands Cancer Institute - Oncology
City
Amsterdam
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Catharina Ziekenhuis - Urology
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
CWZ
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau - Oncología Médica
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
H. de Basurto - Urología
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
POLUSA - Policlínico Lucense - Oncología
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre- Urology
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Central de Asturias (HUCA)
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio- Urología Pediátrica
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

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

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