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

NCT00415246 | Terminated Phase 3

• 2 other identifiers: 2-55-52014-1452006-001511-30
• Study Type: interventional
• Target: 100
• Locations: 8 countries
• Sites: 31

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.

  Day 240

Secondary Outcomes (6)

• 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.

Interventions

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (31)

ULB Erasme

Brussels, B-1070, Belgium

Location

Academisch Ziekenhuis Vrije Universiteit Brussel

Brussels, B-1090, Belgium

Location

UCL St Luc

Brussels, B-1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

UZ Gasthuisberg

Leuven, B-3000, Belgium

Location

CHU Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU Hôpital Salvator

Marseille, 13274, France

Location

Hôtel Dieu

Nantes, 44093, France

Location

Hôpital du Val de Grace

Paris, 75230, France

Location

Centre Hospitalier Saint Louis

Paris, 75475, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Hôpital Bichat

Paris, 75788, France

Location

CHU Hôpital de la Miletrie

Poitiers, 86000, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Olega Hublarova arsta prakse urologija

Daugavpils, Latvia

Location

Latvijas Onkologijas centre

Riga, Latvia

Location

Paula Stradina Kliniska Universitates slimnica

Riga, Latvia

Location

Kauno Medicinos Universitteto Klinikos

Kaunas, Lithuania

Location

UAB 'Vilniaus onkourologijos-ginekologijos klinika

Vilnius, Lithuania

Location

Vilniaus universiteto

Vilnius, Lithuania

Location

Swietokrzyskie Centrum Onkologii

Kielce, Poland

Location

NZOZ Specjalista Sp, z.o.o.

Kutno, Poland

Location

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Warsaw, Poland

Location

Akademicki Szpital Kliniczny

Wroclaw, Poland

Location

Hospital Gregorio Maranon

Madrid, Spain

Location

Ivano Frankovsk State Medical University

Ivano-Frankivsk, Ukraine

Location

Scientific Research Institute of Urology

Kiev, Ukraine

Location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Therapeutics

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: November 1, 2006
• Study Completion: October 1, 2007
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

GB (1); FR (12); LA (3); LI (3); UA (2); PL (4); BE (5); ES (1)