A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Prostate Cancer Clinical Trial

Official title:

A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234350
• Other study ID #: FE200486 CS39
• Status: Completed
• Start date: January 2011
• Est. completion date: March 27, 2018

Study information

• Verified date: June 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1493
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)

• Decision made to prescribe ADT prior to enrolment

• Willing and able to provide written informed consent

Exclusion Criteria:

• Participation in an interventional clinical study in which any treatment or follow-up is mandated

• Treatment with a GnRH receptor antagonist other than FIRMAGON

• Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis	Aalst
Belgium	Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg	Antwerpen
Belgium	AZ Sint-Jan AV	Brugge
Belgium	Hôpital Erasme	Bruxelle
Belgium	Hôpitaux IRIS Sud	Bruxelles
Belgium	Université Catholique de Louvain	Bruxelles
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	AZ Jan Palfijn	Gent
Belgium	AZ Maria Middelares	Gent
Belgium	AZ Sint-Lucas	Gent
Belgium	UZ Gent	Gent
Belgium	Regionaal Ziekenhuis Jan Yperman VZW	Ieper
Belgium	AZ Groeninge - Campus Sint-Maarten	Kortrijk
Belgium	CHU de Liège	Liège
Belgium	Centre Hospitalier Universitaire Ambroise Paré	Mons
Belgium	AZ Damiaan	Oostende
Belgium	AZ-Sint-Elizabeth VZW	Zottegem
Denmark	Aalborg Sygehus	Aalborg
Denmark	Fredericia Hospital, Sygehus Lillebaelt	Fredericia
Denmark	Herlev Hospital	Herlev
Denmark	Holstebro Sygehus	Holstebro
Denmark	Rigshospitalet	Kobenhavn
Denmark	Regionhospitalet Viborg	Viborg
Finland	Docrates clinic	Helsinki
Finland	Pohjois-Karjalan keskussairaala	Joensuu
Finland	Seinäjoen keskussairaala	Seinäjoki
Finland	Tampereen yliopistollinen sairaala	Tampere
Finland	Turun yliopistollinen keskussairaala	Turku
Finland	Peijaksen sairaala	Vantaa
France	CHRU Angers	Angers
France	Centre Hospitalier d'Athis Mons site Caron	Athis Mons
France	Hopital Tenon	Aubervilliers
France	Clinique Rhone Durance	Avignon
France	CHU Saint-Jacques	Besançon
France	Centre Hospitalier Laennec	Clermont Ferrand
France	Chu Gabriel Montpied	Clermont-Ferrand
France	Ramsay Sante	Evry
France	Groupement hospitalier Edouard Herriot	Lyon
France	Cabinet Médical 65 prado	Marseille
France	CHU Nord	Marseille
France	Hopital de la Conception	Marseille
France	Polyclinique Saint-Jean	Melun
France	Clinique du Pont de Chaume	Montauban
France	Clinique Beausoleil	Montpellier
France	Centre d'Urologie de Nancy	Nancy
France	Hôpital Max Fourestier	Nanterre
France	Groupe hospitalo-universitaire Caremeau	Nîmes
France	Centre Hospitalier Georges Renon	Niort
France	Hopital Tenon	Paris
France	Clinique du Ter	Ploemeur
France	Clinic De L'Europe	Pontoise
France	Hopital Pontchaillou	Rennes
France	Clinique Saint Michel	Toulon
France	Clinique St Jean Languedoc	Toulouse
France	Hopital Bretonneau	Tours
France	CHU Brabois	Vandoeuvre les Nancy
Germany	Gemeinschaftspraxis Dres Effert und Benedic	Aachen
Germany	Praxis Dr. Schlichter	Bad Bergzabern
Germany	Praxis Dr. Markus Hentschel	Bautzen
Germany	Praxis Dr. Richter	Bonn
Germany	Urologie im Schlosscarree	Braunschweig
Germany	Praxis Dr. Ahmad Haider	Bremerhaven
Germany	Praxis Dr. Krieger	Chemnitz
Germany	Urologie Chemnitz	Chemnitz
Germany	Gemeinschaftspraxis fur Urologie	Dachau
Germany	Klinikpraxis fur Urologie	Dinslaken
Germany	Praxis Dr. Schönfelder	Hamburg
Germany	Gemeinschaftspraxis Urologie	Kiel
Germany	Urologische Gemeinschaftspraxis	Kiel
Germany	Gemeinshaftspraxis Rudolph & Wörner	Kirchheim
Germany	Praxis Dr. Thomas Harms	Koln
Germany	Vituro	Leipzig
Germany	Praxis Alexander von Keitz	Marburg
Germany	Praxis Dr. Peczat	Nienburg
Germany	Studienzentrum München-Planegg	Planegg
Germany	Urologische Gemeinschaftspraxis	Reutlingen
Germany	Praxis Dr. Jan Franz	Tostedt
Germany	Praxis fur Urologie	Wuppertal
Greece	"Agios Savas" Anticancer-Oncology Hospital of Athens	Athens
Greece	"G. Gennimtas" General Hospital of Athens	Athens
Greece	"Laiko" General Hospital of Athens	Athens
Greece	Amalia Fleming General Hospital of Athens	Athens
Greece	Errikos Dynan Hospital of Athens	Athens
Greece	Eurokliniki Hospital of Athens	Athens
Greece	Evaggelismos General Hospital	Athens
Greece	General Hospital of Athens "Ag. Olga" - Konstantopouleion	Athens
Greece	Ippokrateio Hospital of Athens	Athens
Greece	Korgialenio-Benakio	Athens
Greece	Pe. Pa.G.N:I Hospital	Heraklion
Greece	General hospital of Kalamata	Kalamata
Greece	IASO General Hospital	Kalamata
Greece	University Hospital of Larissa	Larissa
Greece	Aghios Andreas General Hospital of Patras	Patras
Greece	University General Hospital of Patras	Patras
Greece	General Hospital of Piraeus "Tzanneio"	Piraeus
Greece	"G. Gennimtas" General Hospital of Thessaloniki	Thessaloniki
Greece	2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki	Thessaloniki
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki
Greece	General Hospital of Volos "Achillopouleio"	Volos
Hungary	Azarka Zsuzsanna és Társa Bt	Budapest
Hungary	UROFOR Bt	Debrecen
Hungary	Kiskunhalasi Semmelweis Kórház Kht.	Kiskunhalas
Hungary	Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft	Miskolc
Hungary	Uro-Clin Kft	Pécs
Hungary	FEjér Megyei Szent György Kórhaz	Székesfehérvár
Ireland	Beacon Hospital	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	University College Hospital	Galway
Italy	Medical Consulting Center S.r.l.	Avellino
Italy	Azienda Sanitaria Regionale del Molise (ASREM)	Campobasso
Italy	Azienda Ospedaliera Mater Domini di Catanzaro	Catanzaro
Italy	Azienda Ospedaliera Carlo Poma	Mantova
Italy	Ospedale Luigi Sacco	Milano
Italy	Azienda Ospedaliera Monaldi	Napoli
Italy	Azienda Sanitaria Locale Salerno	Nocera Inferiore
Italy	Ospedale Santa Maria delle Croci	Ravenna
Italy	Azienda Ospedaliera "Bianchi-Melacrino-Morelli"	Reggio Calabria
Italy	Istituto Nazionale Tumori "Regina Elena"	Roma
Italy	Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona	Salerno
Italy	ASL 4 di Teramo	Teramo
Italy	Ospedale "San Pio da Pietrelcina"	Vasto
Netherlands	AMC	Amsterdam
Netherlands	MC Haaglanden	Den Haag
Netherlands	Catharina ziekenhuis	Eindhoven
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Diaconessenhuis Leiden	Leiden
Norway	Vestre Viken HF, Sykehuset Asker og Baerum	Asker
Norway	Haukeland Universitetssykehus	Bergen
Norway	Helse Nordmore og Romsdal HF, Kristiansund Sykehus	Kristiansund
Norway	Olso Universitetssykehus HF, Radiumhospitalet	Oslo
Norway	Oslo Universitetssykehus, Aker	Oslo
Portugal	Clinica de Santo Antonio	Lisboa
Portugal	Hospital Militar	Lisboa
Portugal	Hospital Santa Maria	Lisboa
Slovakia	VEBMED, s.r.o.	Bosany
Slovakia	CUIMED, s.r.o.	Bratislava
Slovakia	Nemocnica Svateho Michala, a.s.	Bratislava
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	URO clinic, s.r.o.	Bratislava
Slovakia	Poliklinika Galanta	Galanta
Slovakia	MEDICONA s.r.o.	Kosice
Slovakia	UROCENTRUM LEVICE, s.r.o.	Levice
Slovakia	Poliklinika Malacky	Malacky
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	UROEXAM, spol. s r.o.	Nitra
Slovakia	CENTRUM UROLOGIE Povazska Bystrica s.r.o	Povazska Bystrica
Slovakia	MILAB, s.r.o.	Presov
Slovakia	UROCENTRUM SALA, s.r.o.	Sala
Slovakia	Nemocnica s poliklinikou Skalica, a.s.	Skalica
Slovakia	M & M & M, s.r.o.	Topolcany
Slovakia	PRIVATNA UROLOGICKA AMBULANCIA s.r.o.	Trencin
Slovakia	UROREX, s.r.o.	Vrable
Switzerland	Universitätsspital Basel	Basel
Switzerland	Urozentrum Zürich	Zurich
United Kingdom	Homerton University Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Whipps Cross Hospital	London
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	Sunderland Royal Hospital	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Portugal,  Slovakia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events	The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Primary	Incidence Rate of AESI: Decreased Bone Density	IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Primary	Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)	IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE.; Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Primary	Change in Hepatic Enzymes	Change from baseline in hepatic enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase [ALP]) are presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Primary	Change in Hepatic Enzymes	Change from baseline in hepatic enzyme level (bilirubin) is presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Primary	Change in Serum Glucose	Change from baseline in serum glucose are presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Secondary	Number and Classification of New Adverse Drug Reactions (ADRs)	An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Secondary	Long Term Evaluation of Clinical Evolution of Prostate Cancer	Change in prostate specific antigen (PSA) is presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Secondary	Changes in Testosterone Levels	Change from baseline in testosterone levels are presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Secondary	All-cause of Mortality	A summary of IRs of all-cause mortality is presented.	From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)