Study to Evaluate a Subcutaneous Four Months Sustained-Release Formulation of Triptorelin in Patients With Prostate Cancer
This study has been terminated.
(The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.)
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00415246
First received: December 21, 2006
Last updated: November 15, 2007
Last verified: November 2007
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. [ Time Frame: Day 240 ]
Secondary Outcome Measures:
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL. [ Time Frame: Day 120 ]
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL. [ Time Frame: Day 120 and 240 ]
- Time to achieve castration in days post treatment (Tlag) [ Time Frame: Day 35 ]
- Time to escape from castration (Texit) [ Time Frame: 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2006 |
| Study Completion Date: | October 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415246
Locations
| Belgium | |
| Academisch Ziekenhuis Vrije Universiteit Brussel | |
| Bruxelles, Belgium, B-1090 | |
| UCL St Luc | |
| Bruxelles, Belgium, B-1200 | |
| ULB Erasme | |
| Bruxelles, Belgium, B-1070 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| UZ Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| 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 | |
| Latvia | |
| Olega Hublarova arsta prakse urologija | |
| Daugavpils, Latvia | |
| Latvijas Onkologijas centre | |
| Riga, Latvia | |
| Paula Stradina Kliniska Universitates slimnica | |
| Riga, Latvia | |
| Lithuania | |
| Kauno Medicinos Universitteto Klinikos | |
| Kaunas, Lithuania | |
| Vilniaus universiteto | |
| Vilnius, Lithuania | |
| UAB 'Vilniaus onkourologijos-ginekologijos klinika | |
| Vilnius, Lithuania | |
| Poland | |
| 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 | |
| Spain | |
| Hospital Gregorio Maranon | |
| Madrid, Spain | |
| Ukraine | |
| 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
Ipsen
Investigators
| Study Director: | Beata Maj, MD | Ipsen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00415246 History of Changes |
| Other Study ID Numbers: | 2-55-52014-145 |
| Study First Received: | December 21, 2006 |
| Last Updated: | November 15, 2007 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Latvia: State Agency of Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Lithuania: State Medicine Control Agency - Ministry of Health |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Triptorelin Luteolytic Agents |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013