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
NCT number | NCT01234350 |
Other study ID # | FE200486 CS39 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | March 27, 2018 |
Verified date | June 2019 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Switzerland, United Kingdom,
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) |
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