Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. |  | Day 240 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to escape from castration (Texit) |  | Prior 4 months | 
| Tlag and Texit confirmed by two consecutive measurements taken 1 week apart. |  |  | 
| Duration of castration in days (Tcast) Changes in PSA levels. |  |  |