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Completed

NCT Number: NCT01234350

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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)

    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)

    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)

    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)

    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)

    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)

    Change from baseline in serum glucose are presented.

Secondary outcomes

  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)

    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)

    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)

    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)

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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2010
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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