Clinical trial NCT00967018: A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
Official title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Safety parameters
ECG, blood and urine samples
general health state
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.


Eligibility criteria: Inclusion Criteria:

* Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

* Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

Primary outcomes:
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: Up to 22.5 months
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Up to 22.5 months
Secondary outcomes:
Other outcomes:
measure: Serum Levels of Prostate Specific Antigen (PSA)Over Time
timeFrame: from baseline to 72 weeks
measure: Serum Levels of Testosterone Over Time
timeFrame: from baseline to week 72
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Turnhout
country: Belgium
facility: St. Elisabethziekenhuis
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux Cedex
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre Francois Baclesse
city: Creteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille, Cedex
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: CRLC Val d' Aurelle - Oncology Radiotherapy
city: Paris
country: France
facility: Hôpital Saint Louis - Radiotherapy Departement
city: Paris
country: France
facility: Hôpital Tenon
city: Perigueux
country: France
facility: Clinique Francheville
city: Poitiers
country: France
facility: CHU La Milétrie - Oncology Radiotherapy
city: Saint Herblain Cedex
country: France
facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: St Brieuc Cedex
country: France
facility: Clinique Saint Brieuc
city: Strassbourg
country: France
facility: Centre Paul Strauss
city: Toulon
country: France
facility: Centre de radiologie Saint Louis
city: Toulouse
country: France
facility: Clinique du Parc
city: Villejuif
country: France
facility: IGR
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali riuniti
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
city: Firenze
country: Italy
facility: Clinica Urologica 1 Universita Firenze
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
city: Perugia
country: Italy
facility: Clinica Urologica - Azienda Ospedaliera di Perugia
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
city: San Giovanni Rotondo
country: Italy
facility: S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
city: Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Coimbra
country: Portugal
facility: Hospitais Universidade Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, Hospital Santa Maria
city: Porto
country: Portugal
facility: Hospital S.João
city: Alcalá de Henares-Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcón
city: Barcelona
country: Spain
facility: Fundación Puigvert
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Clinico Universitario S. Carlos
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital universitario Ramón y Cajal
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Manacor
country: Spain
facility: Hospital Manacor
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hospital Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: Fundación IVO
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
city: Göteborg
country: Sweden
facility: Investigational site
city: Göteborg
country: Sweden
facility: SU/Sahlgrenska
city: Helsingborg
country: Sweden
facility: Helsingborgs Lasarett
city: Malmö
country: Sweden
facility: Universitetssjukhuset MAS
city: Södertälje
country: Sweden
facility: Södertälje Sjukhus
city: Uppsala
country: Sweden
facility: Uppsala/Akademiska sjukhuset
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine - Sıhhıye
city: Istanbul
country: Turkey
facility: Cerrahpasa Faculty of Medicine - Kocamustafapasa
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine - ÇAPA
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine - Altunizade
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: