A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
- Conditions
- Prostate Cancer
- Registration Number
- NCT01234350
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1493
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events 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) The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).
Change in Hepatic Enzymes 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) Change from baseline in hepatic enzyme level (bilirubin) is presented.
Incidence Rate of AESI: Decreased Bone Density 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) IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.
Change in Serum Glucose 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) Change from baseline in serum glucose are presented.
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) 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) 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
- Secondary Outcome Measures
Name Time Method Changes in Testosterone Levels 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) Change from baseline in testosterone levels are presented.
All-cause of Mortality 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) A summary of IRs of all-cause mortality is presented.
Long Term Evaluation of Clinical Evolution of Prostate Cancer 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) Change in prostate specific antigen (PSA) is presented.
Number and Classification of New Adverse Drug Reactions (ADRs) 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) 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.
Trial Locations
- Locations (158)
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
🇧🇪Antwerpen, Belgium
AZ Sint-Jan AV
🇧🇪Brugge, Belgium
Université Catholique de Louvain
🇧🇪Bruxelles, Belgium
Hôpital Erasme
🇧🇪Bruxelle, Belgium
AZ Sint-Blasius
🇧🇪Dendermonde, 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, Belgium
Pohjois-Karjalan keskussairaala
🇫🇮Joensuu, Finland
Peijaksen sairaala
🇫🇮Vantaa, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Beaumont Hospital
🇮🇪Dublin, Ireland
University General Hospital of Patras
🇬🇷Patras, Greece
Aghios Andreas General Hospital of Patras
🇬🇷Patras, Greece
Kiskunhalasi Semmelweis Kórház Kht.
🇭🇺Kiskunhalas, Hungary
General Hospital of Piraeus "Tzanneio"
🇬🇷Piraeus, Greece
"G. Gennimtas" General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Papageorgiou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Volos "Achillopouleio"
🇬🇷Volos, Greece
UROFOR Bt
🇭🇺Debrecen, Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
🇭🇺Miskolc, Hungary
Azarka Zsuzsanna és Társa Bt
🇭🇺Budapest, Hungary
2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Uro-Clin Kft
🇭🇺Pécs, Hungary
FEjér Megyei Szent György Kórhaz
🇭🇺Székesfehérvár, Hungary
Diaconessenhuis Leiden
🇳🇱Leiden, Netherlands
Vestre Viken HF, Sykehuset Asker og Baerum
🇳🇴Asker, Norway
Nemocnica Svateho Michala, a.s.
🇸🇰Bratislava, Slovakia
PRIVATNA UROLOGICKA AMBULANCIA s.r.o.
🇸🇰Trencin, Slovakia
UROREX, s.r.o.
🇸🇰Vrable, Slovakia
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
VEBMED, s.r.o.
🇸🇰Bosany, Slovakia
Urozentrum Zürich
🇨🇭Zurich, Switzerland
Clinica de Santo Antonio
🇵🇹Lisboa, Portugal
CUIMED, s.r.o.
🇸🇰Bratislava, Slovakia
URO clinic, s.r.o.
🇸🇰Bratislava, Slovakia
Poliklinika Malacky
🇸🇰Malacky, Slovakia
CENTRUM UROLOGIE Povazska Bystrica s.r.o
🇸🇰Povazska Bystrica, Slovakia
Helse Nordmore og Romsdal HF, Kristiansund Sykehus
🇳🇴Kristiansund, Norway
UROCENTRUM SALA, s.r.o.
🇸🇰Sala, Slovakia
Nemocnica s poliklinikou Skalica, a.s.
🇸🇰Skalica, Slovakia
Olso Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
M & M & M, s.r.o.
🇸🇰Topolcany, Slovakia
MILAB, s.r.o.
🇸🇰Presov, Slovakia
Universitätsspital Basel
🇨🇭Basel, Switzerland
Seinäjoen keskussairaala
🇫🇮Seinäjoki, Finland
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Finland
Beacon Hospital
🇮🇪Dublin, Ireland
CHRU Angers
🇫🇷Angers, France
Centre Hospitalier d'Athis Mons site Caron
🇫🇷Athis Mons, France
Hôpitaux IRIS Sud
🇧🇪Bruxelles, Belgium
AZ Sint-Lucas
🇧🇪Gent, Belgium
Hopital Tenon
🇫🇷Paris, France
Aalborg Sygehus
🇩🇰Aalborg, Denmark
Regionhospitalet Viborg
🇩🇰Viborg, Denmark
UZ Gent
🇧🇪Gent, Belgium
Clinique Rhone Durance
🇫🇷Avignon, France
CHU Nord
🇫🇷Marseille, France
Hopital de la Conception
🇫🇷Marseille, France
Polyclinique Saint-Jean
🇫🇷Melun, France
Holstebro Sygehus
🇩🇰Holstebro, Denmark
Clinique Saint Michel
🇫🇷Toulon, France
East Surrey Hospital
🇬🇧Redhill, United Kingdom
Homerton University Hospital
🇬🇧London, United Kingdom
Urologie im Schlosscarree
🇩🇪Braunschweig, Germany
Klinikpraxis fur Urologie
🇩🇪Dinslaken, Germany
Docrates clinic
🇫🇮Helsinki, Finland
Hôpital Max Fourestier
🇫🇷Nanterre, France
Rigshospitalet
🇩🇰Kobenhavn, Denmark
Chu Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Ramsay Sante
🇫🇷Evry, France
Groupement hospitalier Edouard Herriot
🇫🇷Lyon, France
Clinique St Jean Languedoc
🇫🇷Toulouse, France
CHU Brabois
🇫🇷Vandoeuvre les Nancy, France
Gemeinshaftspraxis Rudolph & Wörner
🇩🇪Kirchheim, Germany
University Hospital of Larissa
🇬🇷Larissa, Greece
University College Hospital
🇮🇪Galway, Ireland
Oslo Universitetssykehus, Aker
🇳🇴Oslo, Norway
Hospital Militar
🇵🇹Lisboa, Portugal
Medical Consulting Center S.r.l.
🇮🇹Avellino, Italy
Azienda Ospedaliera Mater Domini di Catanzaro
🇮🇹Catanzaro, Italy
Azienda Ospedaliera Carlo Poma
🇮🇹Mantova, Italy
Azienda Sanitaria Locale Salerno
🇮🇹Nocera Inferiore, Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
ASL 4 di Teramo
🇮🇹Teramo, Italy
Azienda Sanitaria Regionale del Molise (ASREM)
🇮🇹Campobasso, Italy
Ospedale Luigi Sacco
🇮🇹Milano, Italy
Istituto Nazionale Tumori "Regina Elena"
🇮🇹Roma, Italy
Kings College Hospital
🇬🇧London, United Kingdom
Whipps Cross Hospital
🇬🇧London, United Kingdom
Azienda Ospedaliera Monaldi
🇮🇹Napoli, Italy
Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Ospedale "San Pio da Pietrelcina"
🇮🇹Vasto, Italy
Royal Marsden Hospital
🇬🇧London, United Kingdom
Fredericia Hospital, Sygehus Lillebaelt
🇩🇰Fredericia, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Onze-Lieve-Vrouwziekenhuis
🇧🇪Aalst, Belgium
AZ Jan Palfijn
🇧🇪Gent, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Centre Hospitalier Laennec
🇫🇷Clermont Ferrand, France
CHU Saint-Jacques
🇫🇷Besançon, France
Cabinet Médical 65 prado
🇫🇷Marseille, France
Clinique du Pont de Chaume
🇫🇷Montauban, France
Clinique Beausoleil
🇫🇷Montpellier, France
Centre d'Urologie de Nancy
🇫🇷Nancy, France
Groupe hospitalo-universitaire Caremeau
🇫🇷Nîmes, France
Centre Hospitalier Georges Renon
🇫🇷Niort, France
Clinique du Ter
🇫🇷Ploemeur, France
Clinic De L'Europe
🇫🇷Pontoise, France
Hopital Pontchaillou
🇫🇷Rennes, France
Praxis Dr. Ahmad Haider
🇩🇪Bremerhaven, Germany
Hopital Bretonneau
🇫🇷Tours, France
Praxis Dr. Markus Hentschel
🇩🇪Bautzen, Germany
Gemeinschaftspraxis Dres Effert und Benedic
🇩🇪Aachen, Germany
Praxis Dr. Schlichter
🇩🇪Bad Bergzabern, Germany
Praxis Dr. Richter
🇩🇪Bonn, Germany
Praxis Dr. Krieger
🇩🇪Chemnitz, Germany
Urologie Chemnitz
🇩🇪Chemnitz, Germany
Gemeinschaftspraxis fur Urologie
🇩🇪Dachau, Germany
Gemeinschaftspraxis Urologie
🇩🇪Kiel, Germany
Praxis Dr. Schönfelder
🇩🇪Hamburg, Germany
Urologische Gemeinschaftspraxis
🇩🇪Reutlingen, Germany
Vituro
🇩🇪Leipzig, Germany
Praxis Dr. Thomas Harms
🇩🇪Koln, Germany
Praxis Alexander von Keitz
🇩🇪Marburg, Germany
Praxis Dr. Peczat
🇩🇪Nienburg, Germany
Praxis Dr. Jan Franz
🇩🇪Tostedt, Germany
Studienzentrum München-Planegg
🇩🇪Planegg, Germany
Praxis fur Urologie
🇩🇪Wuppertal, Germany
"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
Ippokrateio Hospital of Athens
🇬🇷Athens, Greece
Korgialenio-Benakio
🇬🇷Athens, Greece
General Hospital of Athens "Ag. Olga" - Konstantopouleion
🇬🇷Athens, Greece
Pe. Pa.G.N:I Hospital
🇬🇷Heraklion, Greece
General hospital of Kalamata
🇬🇷Kalamata, Greece
IASO General Hospital
🇬🇷Kalamata, Greece
AMC
🇳🇱Amsterdam, Netherlands
MC Haaglanden
🇳🇱Den Haag, Netherlands
Catharina ziekenhuis
🇳🇱Eindhoven, Netherlands
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Poliklinika Galanta
🇸🇰Galanta, Slovakia
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
MEDICONA s.r.o.
🇸🇰Kosice, Slovakia
UROCENTRUM LEVICE, s.r.o.
🇸🇰Levice, Slovakia
UROEXAM, spol. s r.o.
🇸🇰Nitra, Slovakia
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom