Prostate Cancer
Conditions
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.
Interventions
DRUGTriptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
Sponsors
Ipsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. | Day 240 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. | Day 120 |
| Tlag and Texit confirmed by two consecutive measurements taken 1 week apart. | — |
| Duration of castration in days (Tcast) Changes in PSA levels. | — |
| Time to escape from castration (Texit) | Prior 4 months |
Countries
Belgium, France, Latvia, Lithuania, Poland, Spain, Ukraine, United Kingdom
Outcome results
None listed