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) - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00444639

Purpose

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. Hormono-therapy 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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Triptorelin (Decapeptyl®)	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Triptorelin Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study
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

Further study details as provided by Ipsen:

Primary Outcome Measures:

Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l). [ Time Frame: Week 24 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	210
Study Start Date:	February 2007

Arms	Assigned Interventions
1: Experimental triptorelin 11.25mg given 12 weekly by subcutaneous formulation	Drug: Triptorelin (Decapeptyl®) Two injections of 11.25mg given every 12 weeks
2: Active Comparator triptorelin 11.25mg given 12 weekly by intramuscular injection	Drug: Triptorelin (Decapeptyl®) Two injections of 11.25mg given every 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444639

Locations

Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3015 GD
AMC Amsterdam
Amsterdam, Netherlands, 1105 AZ
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Diaconessenhuis Leiden
Leiden, Netherlands, 2334 CK
Groen Hart Ziekenhuis
Gouda, Netherlands, 2803 HH
Albert Schweitzer Ziekenhuis
Zwijndrecht, Netherlands, 3331 LZ
St. Anna Ziekenhuis Geldrop
Geldrop, Netherlands, 5664 EH
Ziekenhuis Hilversum
Hilversum, Netherlands, 1213 XZ
Ziekenhuis Gelderse Vallei
Ede, Netherlands, 61717
Deventer Ziekenhuis
Deventer, Netherlands, 7415 EH Deventer
Alysis Zorggroep Loc. Rijnstate
Arnhem, Netherlands, 6815 AD
Maasziekenhuis Pantein
Boxmeer, Netherlands, 5831 HA
Antonius Ziekenhuis
Sneek, Netherlands, 8601 ZK
Westfries Gasthuis Hoorn
Hoorn, Netherlands, 1642 NP

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Danny D'hulster, MD

Ipsen

More Information

Responsible Party:	Ipsen ( Danny D'hulster )
Study ID Numbers:	I-48-52014-142
Study First Received:	March 7, 2007
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00444639
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Triptorelin

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses

Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Luteolytic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009