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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)

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Triptorelin (Decapeptyl®)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vrije Universiteit Medisch Centrum
  • AMC Amsterdam
  • Alysis Zorggroep Loc. Rijnstate
  • Maasziekenhuis Pantein
  • Deventer Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • St. Anna Ziekenhuis Geldrop
  • Groen Hart Ziekenhuis
  • Ziekenhuis Hilversum
  • Westfries Gasthuis Hoorn
  • Diaconessenhuis Leiden
  • Erasmus MC Rotterdam
  • Antonius Ziekenhuis
  • UMC Utrecht
  • Albert Schweitzer Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

triptorelin 11.25mg given 12 weekly by subcutaneous formulation

triptorelin 11.25mg given 12 weekly by intramuscular injection

Outcomes

Primary Outcome Measures

Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).

Secondary Outcome Measures

Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).
Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).

Full Information

First Posted
March 7, 2007
Last Updated
November 21, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00444639
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
triptorelin 11.25mg given 12 weekly by subcutaneous formulation
Arm Title
2
Arm Type
Active Comparator
Arm Description
triptorelin 11.25mg given 12 weekly by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Triptorelin (Decapeptyl®)
Intervention Description
Two injections of 11.25mg given every 12 weeks
Primary Outcome Measure Information:
Title
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Time Frame
Measured at week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
AMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Alysis Zorggroep Loc. Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Maasziekenhuis Pantein
City
Boxmeer
ZIP/Postal Code
5831 HA
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
ZIP/Postal Code
7415 EH Deventer
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
ZIP/Postal Code
61717
Country
Netherlands
Facility Name
St. Anna Ziekenhuis Geldrop
City
Geldrop
ZIP/Postal Code
5664 EH
Country
Netherlands
Facility Name
Groen Hart Ziekenhuis
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Ziekenhuis Hilversum
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Westfries Gasthuis Hoorn
City
Hoorn
ZIP/Postal Code
1642 NP
Country
Netherlands
Facility Name
Diaconessenhuis Leiden
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
Facility Name
Erasmus MC Rotterdam
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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)

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