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)

November 21, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Measured at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-48-52014-142
  • 2005-005058-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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