Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00415246
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. Day 240
- Secondary Outcome Measures
Name Time Method Time to escape from castration (Texit) Prior 4 months Duration of castration in days (Tcast) Changes in PSA levels. Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. Day 120 Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL. Day 120 and 240 Time to achieve castration in days post treatment (Tlag) Day 35 Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Trial Locations
- Locations (31)
ULB Erasme
馃嚙馃嚜Bruxelles, Belgium
H么pital Claude Huriez
馃嚝馃嚪Lille, France
CHU H么pital Salvator
馃嚝馃嚪Marseille, France
Centre Hospitalier Saint Louis
馃嚝馃嚪Paris Cedex 10, France
H么pital Cochin
馃嚝馃嚪Paris cedex 14, France
CHU H么pital de la Miletrie
馃嚝馃嚪Poitiers, France
Hospital Gregorio Maranon
馃嚜馃嚫Madrid, Spain
CHU Rangueil
馃嚝馃嚪Toulouse Cedex 9, France
Latvijas Onkologijas centre
馃嚤馃嚮Riga, Latvia
Paula Stradina Kliniska Universitates slimnica
馃嚤馃嚮Riga, Latvia
Kauno Medicinos Universitteto Klinikos
馃嚤馃嚬Kaunas, Lithuania
UAB 'Vilniaus onkourologijos-ginekologijos klinika
馃嚤馃嚬Vilnius, Lithuania
Swietokrzyskie Centrum Onkologii
馃嚨馃嚤Kielce, Poland
Scientific Research Institute of Urology
馃嚭馃嚘Kiev, Ukraine
Ivano Frankovsk State Medical University
馃嚭馃嚘Ivano-Frankivsk, Ukraine
Aberdeen Royal Infirmary
馃嚞馃嚙Aberdeen, United Kingdom
UCL St Luc
馃嚙馃嚜Bruxelles, Belgium
H么pital Edouard Herriot
馃嚝馃嚪Lyon, France
H么pital Pontchaillou
馃嚝馃嚪Rennes Cedex 9, France
Academisch Ziekenhuis Vrije Universiteit Brussel
馃嚙馃嚜Bruxelles, Belgium
Olega Hublarova arsta prakse urologija
馃嚤馃嚮Daugavpils, Latvia
Universitair Ziekenhuis Antwerpen
馃嚙馃嚜Edegem, Belgium
UZ Gasthuisberg
馃嚙馃嚜Leuven, Belgium
Akademicki Szpital Kliniczny
馃嚨馃嚤Wroclaw, Poland
CHU H么pital Gabriel Montpied
馃嚝馃嚪Clermont Ferrand, France
H么pital du Val de Grace
馃嚝馃嚪Paris Cedex 05, France
H么pital Bichat
馃嚝馃嚪Paris Cedex 18, France
Vilniaus universiteto
馃嚤馃嚬Vilnius, Lithuania
NZOZ Specjalista Sp, z.o.o.
馃嚨馃嚤Kutno, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
馃嚨馃嚤Warszawa, Poland
H么tel Dieu
馃嚝馃嚪Nantes Cedex 1, France