Post Authorisation Safety Study (PASS) on Patients With Advanced Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01234350
First received: November 3, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This study is a large observational study set-up to observe how the long-term treatment of Firmagon (hormone regulator) compared to another treatment will effect specific conditions such as cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in patients with prostate cancer. Patients will be treated according to their routine clinical care and this will not be dictated by the study. As the study is observational in nature, the study will collect specific data relating to the 3 specific events above. Patients that agree to this study will be followed-up for 5 years. Patient data will be collected every 3 months for the first 3 years and every 6 months for the last 3 yrs.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With Firmagon (Degarelix) on a GnRH Agonist

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of adverse events of special interest (AESI) [ Time Frame: Every 3 months from the first 2 years of the trial ] [ Designated as safety issue: Yes ]
    Risk of cardiovascular events, decreased bone density, onset or exacerbation of glucose intolerance and changes in liver enzyme level

  • Incidence of adverse events of special interest (AESI) [ Time Frame: Every 6 months for the last 3 years of the trial ] [ Designated as safety issue: Yes ]
    Risk of cardiovascular events, decreased bone density, onset or exacerbation of glucose intolerance and changes in liver enzyme level


Secondary Outcome Measures:
  • Compare incidence of risks of adverse events (AEs) [ Time Frame: At 3 month intervals from 1-2 years ] [ Designated as safety issue: Yes ]
  • Number and classification of new adverse drug reactions (ADRs) [ Time Frame: At 3 month intervals from 1-2 years ] [ Designated as safety issue: Yes ]
  • Long term evaluation of clinical evolution of prostate cancer [ Time Frame: At 3 month intervals from 1-2 years ] [ Designated as safety issue: Yes ]
  • All causes of mortality [ Time Frame: At 3 month intervals from 1-2 years ] [ Designated as safety issue: Yes ]
  • Compare incidence of risks of adverse events (AEs) [ Time Frame: At 6 month intervals from 3-5 years ] [ Designated as safety issue: Yes ]
  • Number and classification of new adverse drug reactions (ADRs) [ Time Frame: At 6 month intervals from 3-5 years ] [ Designated as safety issue: Yes ]
  • Long term evaluation of clinical evolution of prostate cancer [ Time Frame: At 6 month intervals from 3-5 years ] [ Designated as safety issue: Yes ]
  • All causes of mortality [ Time Frame: At 6 month intervals from 3-5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: January 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Firmagon
GnRH Agonist

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with prostate cancer from primary care

Criteria

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 patients 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234350

  Show 160 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01234350     History of Changes
Other Study ID Numbers: FE200486 CS39
Study First Received: November 3, 2010
Last Updated: April 7, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Norway: Ethics Committee
Denmark: Danish Medicines Agency
United Kingdom: Research Ethics Committee
Greece: National Organization of Medicines
Greece: Ethics Committee
Belgium: Ethics Committee
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Slovak Republic: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014