Status:
TERMINATED
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
Lead Sponsor:
Ipsen
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 tripto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00415246
Start Date
November 1 2006
End Date
October 1 2007
Last Update
November 22 2019
Active Locations (31)
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1
ULB Erasme
Brussels, Belgium, B-1070
2
Academisch Ziekenhuis Vrije Universiteit Brussel
Brussels, Belgium, B-1090
3
UCL St Luc
Brussels, Belgium, B-1200
4
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650