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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00415246
• Other study ID #: 2-55-52014-145
• Secondary ID: 2006-001511-30
• Status: Terminated
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)

Locations

Country	Name	City	State
Belgium	Academisch Ziekenhuis Vrije Universiteit Brussel	Bruxelles
Belgium	UCL St Luc	Bruxelles
Belgium	ULB Erasme	Bruxelles
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	UZ Gasthuisberg	Leuven
France	CHU Hôpital Gabriel Montpied	Clermont Ferrand
France	Hôpital Claude Huriez	Lille
France	Hôpital Edouard Herriot	Lyon
France	CHU Hôpital Salvator	Marseille
France	Hôtel Dieu	Nantes Cedex 1
France	Hôpital du Val de Grace	Paris Cedex 05
France	Centre Hospitalier Saint Louis	Paris Cedex 10
France	Hôpital Cochin	Paris cedex 14
France	Hôpital Bichat	Paris Cedex 18
France	CHU Hôpital de la Miletrie	Poitiers
France	Hôpital Pontchaillou	Rennes Cedex 9
France	CHU Rangueil	Toulouse Cedex 9
Latvia	Olega Hublarova arsta prakse urologija	Daugavpils
Latvia	Latvijas Onkologijas centre	Riga
Latvia	Paula Stradina Kliniska Universitates slimnica	Riga
Lithuania	Kauno Medicinos Universitteto Klinikos	Kaunas
Lithuania	UAB 'Vilniaus onkourologijos-ginekologijos klinika	Vilnius
Lithuania	Vilniaus universiteto	Vilnius
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
Spain	Hospital Gregorio Maranon	Madrid
Ukraine	Ivano Frankovsk State Medical University	Ivano-Frankivsk
Ukraine	Scientific Research Institute of Urology	Kiev
United Kingdom	Aberdeen Royal Infirmary	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  France,  Latvia,  Lithuania,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

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