Clinical trial NCT00415246: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
timeFrame: Day 240
Secondary outcomes:
measure: Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
timeFrame: Day 120
measure: Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
timeFrame: Day 120 and 240
measure: Time to achieve castration in days post treatment (Tlag)
timeFrame: Day 35
measure: Time to escape from castration (Texit)
timeFrame: Prior 4 months
measure: Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
measure: Duration of castration in days (Tcast) Changes in PSA levels.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: ULB Erasme
city: Bruxelles
country: Belgium
facility: Academisch Ziekenhuis Vrije Universiteit Brussel
city: Bruxelles
country: Belgium
facility: UCL St Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Clermont Ferrand
country: France
facility: CHU Hôpital Gabriel Montpied
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: CHU Hôpital Salvator
city: Nantes Cedex 1
country: France
facility: Hôtel Dieu
city: Paris Cedex 05
country: France
facility: Hôpital du Val de Grace
city: Paris Cedex 10
country: France
facility: Centre Hospitalier Saint Louis
city: Paris cedex 14
country: France
facility: Hôpital Cochin
city: Paris Cedex 18
country: France
facility: Hôpital Bichat
city: Poitiers
country: France
facility: CHU Hôpital de la Miletrie
city: Rennes Cedex 9
country: France
facility: Hôpital Pontchaillou
city: Toulouse Cedex 9
country: France
facility: CHU Rangueil
city: Daugavpils
country: Latvia
facility: Olega Hublarova arsta prakse urologija
city: Riga
country: Latvia
facility: Latvijas Onkologijas centre
city: Riga
country: Latvia
facility: Paula Stradina Kliniska Universitates slimnica
city: Kaunas
country: Lithuania
facility: Kauno Medicinos Universitteto Klinikos
city: Vilnius
country: Lithuania
facility: UAB 'Vilniaus onkourologijos-ginekologijos klinika
city: Vilnius
country: Lithuania
facility: Vilniaus universiteto
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii
city: Kutno
country: Poland
facility: NZOZ Specjalista Sp, z.o.o.
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczny
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano Frankovsk State Medical University
city: Kiev
country: Ukraine
facility: Scientific Research Institute of Urology
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: