A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967018
• Other study ID #: FE200486 CS34
• Secondary ID: EudraCT No: 2008
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2009
• Last updated: January 2, 2013
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFinland: Finnish Medicines AgencyNorway: Norwegian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteItaly: The Italian Medicines AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsTurkey: Ministry of HealthSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles
Belgium	St. Elisabethziekenhuis	Turnhout
France	Hopital Jean Minjoz	Besancon
France	Institut Bergonié	Bordeaux Cedex
France	Centre Francois Baclesse	Caen
France	CHU Henri Mondor	Creteil
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Hopital de la Timone	Marseille, Cedex
France	CRLC Val d' Aurelle - Oncology Radiotherapy	Montpellier
France	Hôpital Saint Louis - Radiotherapy Departement	Paris
France	Hôpital Tenon	Paris
France	Clinique Francheville	Perigueux
France	CHU La Milétrie - Oncology Radiotherapy	Poitiers
France	Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau	Saint Herblain Cedex
France	Institut de Cancérologie de la Loire	Saint Priest en Jarez
France	Clinique Saint Brieuc	St Brieuc Cedex
France	Centre Paul Strauss	Strassbourg
France	Centre de radiologie Saint Louis	Toulon
France	Clinique du Parc	Toulouse
France	IGR	Villejuif
Italy	Azienda Ospedaliero Universitaria Ospedali riuniti	Ancona
Italy	Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna	Bologna
Italy	Clinica Urologica 1 Universita Firenze	Firenze
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Milano
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
Portugal	Hospital Fernando da Fonseca	Amadora
Portugal	Hospitais Universidade Coimbra	Coimbra
Portugal	Centro Hospitalar Lisboa Norte, Hospital Santa Maria	Lisboa
Portugal	Hospital S.João	Porto
Spain	Hospital Universitario Principe de Asturias	Alcalá de Henares-Madrid
Spain	Fundacion Hospital Alcorcón	Alcorcon
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	Sevilla
Spain	Fundación IVO	Valencia
Spain	Hospital Xeral de Vigo	Vigo
Sweden	Investigational site	Göteborg
Sweden	SU/Sahlgrenska	Göteborg
Sweden	Helsingborgs Lasarett	Helsingborg
Sweden	Universitetssjukhuset MAS	Malmö
Sweden	Södertälje Sjukhus	Södertälje
Sweden	Uppsala/Akademiska sjukhuset	Uppsala
Turkey	Ankara University Faculty of Medicine - Sihhiye	Ankara
Turkey	Cerrahpasa Faculty of Medicine - Kocamustafapasa	Istanbul
Turkey	Istanbul University Faculty of Medicine - ÇAPA	Istanbul
Turkey	Marmara University Faculty of Medicine - Altunizade	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Portugal,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Levels of Prostate Specific Antigen (PSA)Over Time	PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)	from baseline to 72 weeks	No
Other	Serum Levels of Testosterone Over Time	Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)	from baseline to week 72	No
Primary	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	Yes
Primary	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	Yes