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)

NCT00444639 | Terminated Phase 2

• 2 other identifiers: I-48-52014-1422005-005058-31
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 15

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (3)

• Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).

  Measured at baseline and 12 weeks

• Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).

  Measured at baseline and 12 weeks

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

  Measured at week 12

Study Arms (2)

1

EXPERIMENTAL

triptorelin 11.25mg given 12 weekly by subcutaneous formulation

Drug: Triptorelin (Decapeptyl®)

2

ACTIVE COMPARATOR

triptorelin 11.25mg given 12 weekly by intramuscular injection

Drug: Triptorelin (Decapeptyl®)

Interventions

Triptorelin (Decapeptyl®) DRUG

Two injections of 11.25mg given every 12 weeks

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (15)

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

AMC Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Alysis Zorggroep Loc. Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Maasziekenhuis Pantein

Boxmeer, 5831 HA, Netherlands

Location

Deventer Ziekenhuis

Deventer, 7415 EH Deventer, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 61717, Netherlands

Location

St. Anna Ziekenhuis Geldrop

Geldrop, 5664 EH, Netherlands

Location

Groen Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

Location

Ziekenhuis Hilversum

Hilversum, 1213 XZ, Netherlands

Location

Westfries Gasthuis Hoorn

Hoorn, 1642 NP, Netherlands

Location

Diaconessenhuis Leiden

Leiden, 2334 CK, Netherlands

Location

Erasmus MC Rotterdam

Rotterdam, 3015 GD, Netherlands

Location

Antonius Ziekenhuis

Sneek, 8601 ZK, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Albert Schweitzer Ziekenhuis

Zwijndrecht, 3331 LZ, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

NL (15)