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

June 14, 2019 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1493

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Subjects with prostate cancer from primary care

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FIRMAGON
GnRH Agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
Time Frame: 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).
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)
Incidence Rate of AESI: Decreased Bone Density
Time Frame: 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.
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)
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)
Time Frame: 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
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 Hepatic Enzymes
Time Frame: 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 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)
Change in Hepatic Enzymes
Time Frame: 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.
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 Serum Glucose
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Classification of New Adverse Drug Reactions (ADRs)
Time Frame: 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.
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)
Long Term Evaluation of Clinical Evolution of Prostate Cancer
Time Frame: 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.
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)
Changes in Testosterone Levels
Time Frame: 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.
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)
All-cause of Mortality
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 27, 2018

Study Completion (Actual)

March 27, 2018

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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