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)

NCT ID: NCT00444639

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-06-30

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

triptorelin 11.25mg given 12 weekly by subcutaneous formulation

Group Type: EXPERIMENTAL

Triptorelin (Decapeptyl®)

Intervention Type: DRUG

Two injections of 11.25mg given every 12 weeks

2

triptorelin 11.25mg given 12 weekly by intramuscular injection

Group Type: ACTIVE_COMPARATOR

Triptorelin (Decapeptyl®)

Intervention Type: DRUG

Two injections of 11.25mg given every 12 weeks

Interventions

Triptorelin (Decapeptyl®)

Two injections of 11.25mg given every 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

AMC Amsterdam

Amsterdam, , Netherlands

Alysis Zorggroep Loc. Rijnstate

Arnhem, , Netherlands

Maasziekenhuis Pantein

Boxmeer, , Netherlands

Deventer Ziekenhuis

Deventer, , Netherlands

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

St. Anna Ziekenhuis Geldrop

Geldrop, , Netherlands

Groen Hart Ziekenhuis

Gouda, , Netherlands

Ziekenhuis Hilversum

Hilversum, , Netherlands

Westfries Gasthuis Hoorn

Hoorn, , Netherlands

Diaconessenhuis Leiden

Leiden, , Netherlands

Erasmus MC Rotterdam

Rotterdam, , Netherlands

Antonius Ziekenhuis

Sneek, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Albert Schweitzer Ziekenhuis

Zwijndrecht, , Netherlands

Countries

Netherlands

Other Identifiers

2005-005058-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

I-48-52014-142

Identifier Type: -

Identifier Source: org_study_id