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

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
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 October 31, 2008

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