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)

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Triptorelin (Decapeptyl®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444639

2005-005058-31 (EudraCT Number)

I-48-52014-142

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

1

Experimental group

Description:

triptorelin 11.25mg given 12 weekly by subcutaneous formulation

Treatment:

Drug: Triptorelin (Decapeptyl®)

2

Active Comparator group

Description:

triptorelin 11.25mg given 12 weekly by intramuscular injection

Treatment:

Drug: Triptorelin (Decapeptyl®)