Clinical trial NCT00444639: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
timeFrame: Week 24
Secondary outcomes:
measure: Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).
timeFrame: Measured at baseline and 12 weeks
measure: Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).
timeFrame: Measured at baseline and 12 weeks
measure: Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
timeFrame: Measured at week 12
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep Loc. Rijnstate
city: Boxmeer
country: Netherlands
facility: Maasziekenhuis Pantein
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis Geldrop
city: Gouda
country: Netherlands
facility: Groen Hart Ziekenhuis
city: Hilversum
country: Netherlands
facility: Ziekenhuis Hilversum
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis Hoorn
city: Leiden
country: Netherlands
facility: Diaconessenhuis Leiden
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: