Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
Phase 3
Terminated
- 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
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
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
🇧🇪Bruxelles, Belgium
Academisch Ziekenhuis Vrije Universiteit Brussel
🇧🇪Bruxelles, Belgium
UCL St Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
CHU Hôpital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hôpital Claude Huriez
🇫🇷Lille, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
CHU Hôpital Salvator
🇫🇷Marseille, France
Hôtel Dieu
🇫🇷Nantes Cedex 1, France
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