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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)

This study has been terminated.
(Low recruitment)
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00444639
First received: March 7, 2007
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  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. 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.


Condition Intervention Phase
Prostate Cancer
 Drug: Triptorelin (Decapeptyl®)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 25
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
triptorelin 11.25mg given 12 weekly by subcutaneous formulation
 Drug: Triptorelin (Decapeptyl®)
Two injections of 11.25mg given every 12 weeks
Active Comparator: 2
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
AMC Amsterdam
Amsterdam, Netherlands, 1105 AZ
Alysis Zorggroep Loc. Rijnstate
Arnhem, Netherlands, 6815 AD
Maasziekenhuis Pantein
Boxmeer, Netherlands, 5831 HA
Deventer Ziekenhuis
Deventer, Netherlands, 7415 EH Deventer
Ziekenhuis Gelderse Vallei
Ede, Netherlands, 61717
St. Anna Ziekenhuis Geldrop
Geldrop, Netherlands, 5664 EH
Groen Hart Ziekenhuis
Gouda, Netherlands, 2803 HH
Ziekenhuis Hilversum
Hilversum, Netherlands, 1213 XZ
Westfries Gasthuis Hoorn
Hoorn, Netherlands, 1642 NP
Diaconessenhuis Leiden
Leiden, Netherlands, 2334 CK
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3015 GD
Antonius Ziekenhuis
Sneek, Netherlands, 8601 ZK
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Albert Schweitzer Ziekenhuis
Zwijndrecht, Netherlands, 3331 LZ
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Patrick Cabri, MD Ipsen
  More Information

No publications provided

Responsible Party: Patrick Cabri, Ipsen
ClinicalTrials.gov Identifier: NCT00444639     History of Changes
Other Study ID Numbers: I-48-52014-142
Study First Received: March 7, 2007
Last Updated: December 10, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Prostatic Neoplasms
Stress, Psychological
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms
Triptorelin
 Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013