A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
2 other identifiers
interventional
77
7 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Aug 2009
Shorter than P25 for phase_3 prostate-cancer
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
December 24, 2012
CompletedJanuary 3, 2013
January 1, 2013
2.3 years
August 18, 2009
November 23, 2012
January 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Up to 22.5 months
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Up to 22.5 months
Other Outcomes (2)
Serum Levels of Prostate Specific Antigen (PSA)Over Time
from baseline to 72 weeks
Serum Levels of Testosterone Over Time
from baseline to week 72
Study Arms (1)
Degarelix
EXPERIMENTALThe degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Interventions
Eligibility Criteria
You may qualify if:
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
You may not qualify if:
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Institut Jules Bordet
Brussels, Belgium
St. Elisabethziekenhuis
Turnhout, Belgium
Hopital Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
Centre Francois Baclesse
Caen, France
CHU Henri Mondor
Créteil, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Hopital de la Timone
Marseille, France
CRLC Val d' Aurelle - Oncology Radiotherapy
Montpellier, France
Hôpital Saint Louis - Radiotherapy Departement
Paris, France
Hôpital Tenon
Paris, France
Clinique Francheville
Périgueux, France
CHU La Milétrie - Oncology Radiotherapy
Poitiers, France
Clinique Saint Brieuc
Saint-Brieuc, France
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
Saint-Herblain, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
Centre Paul Strauss
Strasbourg, France
Centre de radiologie Saint Louis
Toulon, France
Clinique du Parc
Toulouse, France
IGR
Villejuif, France
Azienda Ospedaliero Universitaria Ospedali riuniti
Ancona, Italy
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
Bologna, Italy
Clinica Urologica 1 Universita Firenze
Florence, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
Palermo, Italy
Clinica Urologica - Azienda Ospedaliera di Perugia
Perugia, Italy
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
Roma, Italy
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
Torino, Italy
Hospital Fernando da Fonseca
Amadora, Portugal
Hospitais Universidade Coimbra
Coimbra, Portugal
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
Lisbon, Portugal
Hospital S.João
Porto, Portugal
Hospital Universitario Principe de Asturias
Alcalá de Henares-Madrid, Spain
Fundacion Hospital Alcorcón
Alcorcón, Spain
Fundación Puigvert
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital Clinico Universitario S. Carlos
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Hospital Manacor
Manacor, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Santiago de Compostela
Santiago de Compostela, Spain
Hospital Virgen Macarena
Seville, Spain
Fundación IVO
Valencia, Spain
Hospital Xeral de Vigo
Vigo, Spain
Investigational site
Gothenburg, Sweden
SU/Sahlgrenska
Gothenburg, Sweden
Helsingborgs Lasarett
Helsingborg, Sweden
Universitetssjukhuset MAS
Malmo, Sweden
Södertälje Sjukhus
Södertälje, Sweden
Uppsala/Akademiska sjukhuset
Uppsala, Sweden
Ankara University Faculty of Medicine - Sıhhıye
Ankara, Turkey (Türkiye)
Cerrahpasa Faculty of Medicine - Kocamustafapasa
Istanbul, Turkey (Türkiye)
Istanbul University Faculty of Medicine - ÇAPA
Istanbul, Turkey (Türkiye)
Marmara University Faculty of Medicine - Altunizade
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 27, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
January 3, 2013
Results First Posted
December 24, 2012
Record last verified: 2013-01