Clinical trial NCT01234350: A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
Official title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 1493
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with prostate cancer from primary care

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
timeFrame: 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)
measure: Incidence Rate of AESI: Decreased Bone Density
timeFrame: 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)
measure: Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)
timeFrame: 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)
measure: Change in Hepatic Enzymes
timeFrame: 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)
measure: Change in Hepatic Enzymes
timeFrame: 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)
measure: Change in Serum Glucose
timeFrame: 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 outcomes:
measure: Number and Classification of New Adverse Drug Reactions (ADRs)
timeFrame: 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)
measure: Long Term Evaluation of Clinical Evolution of Prostate Cancer
timeFrame: 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)
measure: Changes in Testosterone Levels
timeFrame: 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)
measure: All-cause of Mortality
timeFrame: 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)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis
city: Antwerpen
country: Belgium
facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV
city: Bruxelles
country: Belgium
facility: Hôpitaux IRIS Sud
city: Bruxelles
country: Belgium
facility: Université Catholique de Louvain
city: Bruxelle
country: Belgium
facility: Hôpital Erasme
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Gent
country: Belgium
facility: AZ Jan Palfijn
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Ieper
country: Belgium
facility: Regionaal Ziekenhuis Jan Yperman VZW
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Sint-Maarten
city: Liège
country: Belgium
facility: CHU de Liège
city: Mons
country: Belgium
facility: Centre Hospitalier Universitaire Ambroise Paré
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Zottegem
country: Belgium
facility: AZ-Sint-Elizabeth VZW
city: Aalborg
country: Denmark
facility: Aalborg Sygehus
city: Fredericia
country: Denmark
facility: Fredericia Hospital, Sygehus Lillebaelt
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holstebro
country: Denmark
facility: Holstebro Sygehus
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
city: Viborg
country: Denmark
facility: Regionhospitalet Viborg
city: Helsinki
country: Finland
facility: Docrates clinic
city: Joensuu
country: Finland
facility: Pohjois-Karjalan keskussairaala
city: Seinäjoki
country: Finland
facility: Seinäjoen keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Vantaa
country: Finland
facility: Peijaksen sairaala
city: Angers
country: France
facility: CHRU Angers
city: Athis Mons
country: France
facility: Centre Hospitalier d'Athis Mons site Caron
city: Aubervilliers
country: France
facility: Hopital Tenon
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Besançon
country: France
facility: CHU Saint-Jacques
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Laennec
city: Clermont-Ferrand
country: France
facility: Chu Gabriel Montpied
city: Evry
country: France
facility: Ramsay Sante
city: Lyon
country: France
facility: Groupement hospitalier Edouard Herriot
city: Marseille
country: France
facility: Cabinet Médical 65 prado
city: Marseille
country: France
facility: CHU Nord
city: Marseille
country: France
facility: Hopital de la Conception
city: Melun
country: France
facility: Polyclinique Saint-Jean
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Montpellier
country: France
facility: Clinique Beausoleil
city: Nancy
country: France
facility: Centre d'Urologie de Nancy
city: Nanterre
country: France
facility: Hôpital Max Fourestier
city: Niort
country: France
facility: Centre Hospitalier Georges Renon
city: Nîmes
country: France
facility: Groupe hospitalo-universitaire Caremeau
city: Paris
country: France
facility: Hopital Tenon
city: Ploemeur
country: France
facility: Clinique du Ter
city: Pontoise
country: France
facility: Clinic De L'Europe
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Toulon
country: France
facility: Clinique Saint Michel
city: Toulouse
country: France
facility: Clinique St Jean Languedoc
city: Tours
country: France
facility: Hopital Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: CHU Brabois
city: Aachen
country: Germany
facility: Gemeinschaftspraxis Dres Effert und Benedic
city: Bad Bergzabern
country: Germany
facility: Praxis Dr. Schlichter
city: Bautzen
country: Germany
facility: Praxis Dr. Markus Hentschel
city: Bonn
country: Germany
facility: Praxis Dr. Richter
city: Braunschweig
country: Germany
facility: Urologie im Schlosscarree
city: Bremerhaven
country: Germany
facility: Praxis Dr. Ahmad Haider
city: Chemnitz
country: Germany
facility: Praxis Dr. Krieger
city: Chemnitz
country: Germany
facility: Urologie Chemnitz
city: Dachau
country: Germany
facility: Gemeinschaftspraxis fur Urologie
city: Dinslaken
country: Germany
facility: Klinikpraxis fur Urologie
city: Hamburg
country: Germany
facility: Praxis Dr. Schönfelder
city: Kiel
country: Germany
facility: Gemeinschaftspraxis Urologie
city: Kiel
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Kirchheim
country: Germany
facility: Gemeinshaftspraxis Rudolph & Wörner
city: Koln
country: Germany
facility: Praxis Dr. Thomas Harms
city: Leipzig
country: Germany
facility: Vituro
city: Marburg
country: Germany
facility: Praxis Alexander von Keitz
city: Nienburg
country: Germany
facility: Praxis Dr. Peczat
city: Planegg
country: Germany
facility: Studienzentrum München-Planegg
city: Reutlingen
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Tostedt
country: Germany
facility: Praxis Dr. Jan Franz
city: Wuppertal
country: Germany
facility: Praxis fur Urologie
city: Athens
country: Greece
facility: "Agios Savas" Anticancer-Oncology Hospital of Athens
city: Athens
country: Greece
facility: "G. Gennimtas" General Hospital of Athens
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Amalia Fleming General Hospital of Athens
city: Athens
country: Greece
facility: Errikos Dynan Hospital of Athens
city: Athens
country: Greece
facility: Eurokliniki Hospital of Athens
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Athens
country: Greece
facility: General Hospital of Athens "Ag. Olga" - Konstantopouleion
city: Athens
country: Greece
facility: Ippokrateio Hospital of Athens
city: Athens
country: Greece
facility: Korgialenio-Benakio
city: Heraklion
country: Greece
facility: Pe. Pa.G.N:I Hospital
city: Kalamata
country: Greece
facility: General hospital of Kalamata
city: Kalamata
country: Greece
facility: IASO General Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: Aghios Andreas General Hospital of Patras
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Piraeus
country: Greece
facility: General Hospital of Piraeus "Tzanneio"
city: Thessaloniki
country: Greece
facility: "G. Gennimtas" General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: 2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Volos
country: Greece
facility: General Hospital of Volos "Achillopouleio"
city: Budapest
country: Hungary
facility: Azarka Zsuzsanna és Társa Bt
city: Debrecen
country: Hungary
facility: UROFOR Bt
city: Kiskunhalas
country: Hungary
facility: Kiskunhalasi Semmelweis Kórház Kht.
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
city: Pécs
country: Hungary
facility: Uro-Clin Kft
city: Székesfehérvár
country: Hungary
facility: FEjér Megyei Szent György Kórhaz
city: Dublin
country: Ireland
facility: Beacon Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University College Hospital
city: Avellino
country: Italy
facility: Medical Consulting Center S.r.l.
city: Campobasso
country: Italy
facility: Azienda Sanitaria Regionale del Molise (ASREM)
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini di Catanzaro
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
city: Nocera Inferiore
country: Italy
facility: Azienda Sanitaria Locale Salerno
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
city: Roma
country: Italy
facility: Istituto Nazionale Tumori "Regina Elena"
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona
city: Teramo
country: Italy
facility: ASL 4 di Teramo
city: Vasto
country: Italy
facility: Ospedale "San Pio da Pietrelcina"
city: Amsterdam
country: Netherlands
facility: AMC
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Leiden
country: Netherlands
facility: Diaconessenhuis Leiden
city: Asker
country: Norway
facility: Vestre Viken HF, Sykehuset Asker og Baerum
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Kristiansund
country: Norway
facility: Helse Nordmore og Romsdal HF, Kristiansund Sykehus
city: Oslo
country: Norway
facility: Olso Universitetssykehus HF, Radiumhospitalet
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Aker
city: Lisboa
country: Portugal
facility: Clinica de Santo Antonio
city: Lisboa
country: Portugal
facility: Hospital Militar
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Bosany
country: Slovakia
facility: VEBMED, s.r.o.
city: Bratislava
country: Slovakia
facility: CUIMED, s.r.o.
city: Bratislava
country: Slovakia
facility: Nemocnica Svateho Michala, a.s.
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: URO clinic, s.r.o.
city: Galanta
country: Slovakia
facility: Poliklinika Galanta
city: Kosice
country: Slovakia
facility: MEDICONA s.r.o.
city: Levice
country: Slovakia
facility: UROCENTRUM LEVICE, s.r.o.
city: Malacky
country: Slovakia
facility: Poliklinika Malacky
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: UROEXAM, spol. s r.o.
city: Povazska Bystrica
country: Slovakia
facility: CENTRUM UROLOGIE Povazska Bystrica s.r.o
city: Presov
country: Slovakia
facility: MILAB, s.r.o.
city: Sala
country: Slovakia
facility: UROCENTRUM SALA, s.r.o.
city: Skalica
country: Slovakia
facility: Nemocnica s poliklinikou Skalica, a.s.
city: Topolcany
country: Slovakia
facility: M & M & M, s.r.o.
city: Trencin
country: Slovakia
facility: PRIVATNA UROLOGICKA AMBULANCIA s.r.o.
city: Vrable
country: Slovakia
facility: UROREX, s.r.o.
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zurich
country: Switzerland
facility: Urozentrum Zürich
city: London
country: United Kingdom
facility: Homerton University Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: