Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

Study Overview
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Brief Summary
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The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.

Official Title
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Phase II Multi-Centric, Randomised, Open-label, Parallel-Group Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Triptorelin (Decapeptyl®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy Life expectancy of more than 9 months Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months Exclusion Criteria: Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study Concomitant anti-coagulation treatment Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study Patient with known spinal medullar compression

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>triptorelin 11.25mg given 12 weekly by subcutaneous formulation | Drug: Triptorelin (Decapeptyl®)<br>* Two injections of 11.25mg given every 12 weeks<br>|
| Active Comparator: 2<br>triptorelin 11.25mg given 12 weekly by intramuscular injection | Drug: Triptorelin (Decapeptyl®)<br>* Two injections of 11.25mg given every 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l). |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS). |  | Measured at baseline and 12 weeks | 
| Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS). |  | Measured at baseline and 12 weeks | 
| Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l). |  | Measured at week 12 |