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

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ClinicalTrials.gov Identifier: NCT00415246
Recruitment Status : Terminated (The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.)
First Posted : December 22, 2006
Last Update Posted : November 16, 2007
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2006
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. [ Time Frame: Day 240 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415246

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

ClinicalTrials.gov Identifier: NCT00415246     History of Changes
Other Study ID Numbers: 2-55-52014-145
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents