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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00415246

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 III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH Triptorelin Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Beata Maj, MD

Ipsen

More Information

Study ID Numbers:	2-55-52014-145
Study First Received:	December 21, 2006
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00415246
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Triptorelin

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses

Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Luteolytic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009