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

This study has been terminated.
(The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.)
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00415246
First received: December 21, 2006
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. [ Time Frame: Day 240 ]

Secondary Outcome Measures:
  • Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. [ Time Frame: Day 120 ]
  • Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL. [ Time Frame: Day 120 and 240 ]
  • Time to achieve castration in days post treatment (Tlag) [ Time Frame: Day 35 ]
  • Time to escape from castration (Texit) [ Time Frame: Prior 4 months ]
  • Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
  • Duration of castration in days (Tcast) Changes in PSA levels.

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415246

Locations
Belgium
Academisch Ziekenhuis Vrije Universiteit Brussel
Bruxelles, Belgium, B-1090
UCL St Luc
Bruxelles, Belgium, B-1200
ULB Erasme
Bruxelles, Belgium, B-1070
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
UZ Gasthuisberg
Leuven, Belgium, B-3000
France
CHU Hôpital Gabriel Montpied
Clermont Ferrand, France, 63003
Hôpital Claude Huriez
Lille, France, 59037
Hôpital Edouard Herriot
Lyon, France, 69437
CHU Hôpital Salvator
Marseille, France, 13274
Hôtel Dieu
Nantes Cedex 1, France, 44093
Hôpital du Val de Grace
Paris Cedex 05, France, 75230
Centre Hospitalier Saint Louis
Paris Cedex 10, France, 75475
Hôpital Cochin
Paris cedex 14, France, 75679
Hôpital Bichat
Paris Cedex 18, France, 75788
CHU Hôpital de la Miletrie
Poitiers, France, 86000
Hôpital Pontchaillou
Rennes Cedex 9, France, 35033
CHU Rangueil
Toulouse Cedex 9, France, 31059
Latvia
Olega Hublarova arsta prakse urologija
Daugavpils, Latvia
Latvijas Onkologijas centre
Riga, Latvia
Paula Stradina Kliniska Universitates slimnica
Riga, Latvia
Lithuania
Kauno Medicinos Universitteto Klinikos
Kaunas, Lithuania
Vilniaus universiteto
Vilnius, Lithuania
UAB 'Vilniaus onkourologijos-ginekologijos klinika
Vilnius, Lithuania
Poland
Swietokrzyskie Centrum Onkologii
Kielce, Poland
NZOZ Specjalista Sp, z.o.o.
Kutno, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warszawa, Poland
Akademicki Szpital Kliniczny
Wroclaw, Poland
Spain
Hospital Gregorio Maranon
Madrid, Spain
Ukraine
Ivano Frankovsk State Medical University
Ivano-Frankivsk, Ukraine
Scientific Research Institute of Urology
Kiev, Ukraine
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Beata Maj, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415246     History of Changes
Other Study ID Numbers: 2-55-52014-145
Study First Received: December 21, 2006
Last Updated: November 15, 2007
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Lithuania: State Medicine Control Agency - Ministry of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014