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Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
Sponsored by
Ipsen
About
Eligibility
Locations
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:

  • Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
  • Patient must be 18 years old or over
  • Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
  • Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment

Exclusion Criteria:

  • Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
  • Patient who underwent a previous surgical castration
  • Prostate cancer therapy within 2 months of baseline visit
  • Patient with testosterone level below 150 ng/dL at screening

Sites / Locations

  • ULB Erasme
  • Academisch Ziekenhuis Vrije Universiteit Brussel
  • UCL St Luc
  • Universitair Ziekenhuis Antwerpen
  • UZ Gasthuisberg
  • CHU Hôpital Gabriel Montpied
  • Hôpital Claude Huriez
  • Hôpital Edouard Herriot
  • CHU Hôpital Salvator
  • Hôtel Dieu
  • Hôpital du Val de Grace
  • Centre Hospitalier Saint Louis
  • Hôpital Cochin
  • Hôpital Bichat
  • CHU Hôpital de la Miletrie
  • Hôpital Pontchaillou
  • CHU Rangueil
  • Olega Hublarova arsta prakse urologija
  • Latvijas Onkologijas centre
  • Paula Stradina Kliniska Universitates slimnica
  • Kauno Medicinos Universitteto Klinikos
  • UAB 'Vilniaus onkourologijos-ginekologijos klinika
  • Vilniaus universiteto
  • Swietokrzyskie Centrum Onkologii
  • NZOZ Specjalista Sp, z.o.o.
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Akademicki Szpital Kliniczny
  • Hospital Gregorio Maranon
  • Ivano Frankovsk State Medical University
  • Scientific Research Institute of Urology
  • Aberdeen Royal Infirmary

Outcomes

Primary Outcome Measures

Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.

Secondary Outcome Measures

Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
Time to achieve castration in days post treatment (Tlag)
Time to escape from castration (Texit)
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Duration of castration in days (Tcast) Changes in PSA levels.

Full Information

First Posted
December 21, 2006
Last Updated
November 21, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00415246
Brief Title
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
Official Title
A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

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
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
Primary Outcome Measure Information:
Title
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time Frame
Day 240
Secondary Outcome Measure Information:
Title
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time Frame
Day 120
Title
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
Time Frame
Day 120 and 240
Title
Time to achieve castration in days post treatment (Tlag)
Time Frame
Day 35
Title
Time to escape from castration (Texit)
Time Frame
Prior 4 months
Title
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Title
Duration of castration in days (Tcast) Changes in PSA levels.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient Patient must be 18 years old or over Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment Exclusion Criteria: Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy) Patient who underwent a previous surgical castration Prostate cancer therapy within 2 months of baseline visit Patient with testosterone level below 150 ng/dL at screening
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
ULB Erasme
City
Bruxelles
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Academisch Ziekenhuis Vrije Universiteit Brussel
City
Bruxelles
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
UCL St Luc
City
Bruxelles
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Hôpital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU Hôpital Salvator
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hôtel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital du Val de Grace
City
Paris Cedex 05
ZIP/Postal Code
75230
Country
France
Facility Name
Centre Hospitalier Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Cochin
City
Paris cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital Bichat
City
Paris Cedex 18
ZIP/Postal Code
75788
Country
France
Facility Name
CHU Hôpital de la Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Olega Hublarova arsta prakse urologija
City
Daugavpils
Country
Latvia
Facility Name
Latvijas Onkologijas centre
City
Riga
Country
Latvia
Facility Name
Paula Stradina Kliniska Universitates slimnica
City
Riga
Country
Latvia
Facility Name
Kauno Medicinos Universitteto Klinikos
City
Kaunas
Country
Lithuania
Facility Name
UAB 'Vilniaus onkourologijos-ginekologijos klinika
City
Vilnius
Country
Lithuania
Facility Name
Vilniaus universiteto
City
Vilnius
Country
Lithuania
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
Country
Poland
Facility Name
NZOZ Specjalista Sp, z.o.o.
City
Kutno
Country
Poland
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
City
Warszawa
Country
Poland
Facility Name
Akademicki Szpital Kliniczny
City
Wroclaw
Country
Poland
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Ivano Frankovsk State Medical University
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Scientific Research Institute of Urology
City
Kiev
Country
Ukraine
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom

12. IPD Sharing Statement

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Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

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