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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01234350 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS39
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,493 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Not stated
Countries
15 countries

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

Start
Jan 2011
Primary completion
27 Mar 2018
Completion
27 Mar 2018
First posted
4 Nov 2010 (estimated)
Last update posted
25 Jun 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph –

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

    NCT01234350

    Jan 2011 to 27 Mar 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms2

  • Other

    FIRMAGON

  • Other

    GnRH Agonist

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).

  2. 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)

    Registry description

    IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.

  3. 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)

    Registry description

    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

  4. 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)

    Registry description

    Change from baseline in hepatic enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase \[ALP\]) are presented.

  5. 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)

    Registry description

    Change from baseline in hepatic enzyme level (bilirubin) is presented.

  6. 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)

    Registry description

    Change from baseline in serum glucose are presented.

Secondary outcomes(4)

  1. 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)

    Registry description

    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.

  2. 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)

    Registry description

    Change in prostate specific antigen (PSA) is presented.

  3. 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)

    Registry description

    Change from baseline in testosterone levels are presented.

  4. 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)

    Registry description

    A summary of IRs of all-cause mortality is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 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 Adverse Events of Special Interest (AESI): Cardiovascular Events

GroupValue (Events per 100 PYE)
FIRMAGON3.8
GnRH Agonist4.5
Primary outcomeNumber· 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

GroupValue (Events per 100 PYE)
FIRMAGON1.1
GnRH Agonist1.4
Primary outcomeNumber· 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)

GroupValue (Events per 100 PYE)
FIRMAGON15.3
GnRH Agonist13.2
Primary outcomeMedian· 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

GroupValue (IU/L)
FIRMAGON0.1
GnRH Agonist0.1
Primary outcomeMedian· 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

GroupValue (umol/L)
FIRMAGON-1.0
GnRH Agonist-1.0
Primary outcomeMedian· 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

GroupValue (mmol/L)
FIRMAGON0.0
GnRH Agonist0.0
Secondary and other outcome results(2)
Secondary outcomeNumber· 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)

Number and Classification of New Adverse Drug Reactions (ADRs)

GroupValue (New ADR)
FIRMAGON0
GnRH Agonist0
Secondary outcomeMedian· 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

GroupValue (ng/mL)
FIRMAGON-20.1
GnRH Agonist-10.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FIRMAGONFIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label141 / 1000236 / 1000294 / 1000
GnRH AgonistAny GnRH agonist prescribed in accordance with the approved labels72 / 493144 / 493110 / 493

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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