Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer

To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • ULB Erasme
  • Bruxelles, Belgium, B-1090
    • Academisch Ziekenhuis Vrije Universiteit Brussel
  • Bruxelles, Belgium, B-1200
    • UCL St Luc
  • Edegem, Belgium, B-2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, B-3000
    • Uz Gasthuisberg
• France
  • Clermont Ferrand, France, 63003
    • CHU Hôpital Gabriel Montpied
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13274
    • CHU Hôpital Salvator
  • Nantes Cedex 1, France, 44093
    • Hotel Dieu
  • Paris Cedex 05, France, 75230
    • Hôpital du Val de Grâce
  • Paris Cedex 10, France, 75475
    • Centre Hospitalier Saint Louis
  • Paris Cedex 18, France, 75788
    • Hôpital Bichat
  • Paris cedex 14, France, 75679
    • Hopital Cochin
  • Poitiers, France, 86000
    • CHU Hôpital de la Milétrie
  • Rennes Cedex 9, France, 35033
    • Hopital Pontchaillou
  • Toulouse Cedex 9, France, 31059
    • CHU Rangueil
• Latvia
  • Daugavpils, Latvia
    • Olega Hublarova arsta prakse urologija
  • Riga, Latvia
    • Latvijas Onkologijas centre
  • Riga, Latvia
    • Paula Stradiņa klīniskā universitates slimnīca
• Lithuania
  • Kaunas, Lithuania
    • Kauno Medicinos Universitteto Klinikos
  • Vilnius, Lithuania
    • UAB 'Vilniaus onkourologijos-ginekologijos klinika
  • Vilnius, Lithuania
    • Vilniaus Universiteto
• Poland
  • Kielce, Poland
    • Swietokrzyskie Centrum Onkologii
  • Kutno, Poland
    • NZOZ Specjalista Sp, z.o.o.
  • Warszawa, Poland
    • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Wroclaw, Poland
    • Akademicki Szpital Kliniczny
• Spain
  • Madrid, Spain
    • Hospital Gregorio Marañón
• Ukraine
  • Ivano-Frankivsk, Ukraine
    • Ivano Frankovsk State Medical University
  • Kiev, Ukraine
    • Scientific Research Institute of Urology
• United Kingdom
  • Aberdeen, United Kingdom
    • Aberdeen Royal Infirmary

Participation Criteria

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:

• Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
• Patient must be 18 years old or over
• Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
• Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment

Exclusion Criteria:

• Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
• Patient who underwent a previous surgical castration
• Prostate cancer therapy within 2 months of baseline visit
• Patient with testosterone level below 150 ng/dL at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.	Day 240

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.	Day 120
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.	Day 120 and 240
Time to achieve castration in days post treatment (Tlag)	Day 35
Time to escape from castration (Texit)	Prior 4 months
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Duration of castration in days (Tcast) Changes in PSA levels.

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: December 21, 2006
• First Submitted That Met QC Criteria: December 21, 2006
• First Posted (Estimate): December 22, 2006

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: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: 2-55-52014-145; 2006-001511-30 (EudraCT Number)