Overview

This trial is active, not recruiting.

Condition prostate cancer
Sponsor Ferring Pharmaceuticals
Start date January 2011
End date May 2018
Trial size 1511 participants
Trial identifier NCT01234350, FE200486 CS39

Summary

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 2 years and every 6 months for the last 3 yrs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Incidence of adverse events of special interest (AESI)
time frame: Every 3 months from the first 2 years of the trial
Incidence of adverse events of special interest (AESI)
time frame: Every 6 months for the last 3 years of the trial

Secondary Outcomes

Measure
Compare incidence of risks of adverse events (AEs)
time frame: At 3 month intervals from 1-2 years
Number and classification of new adverse drug reactions (ADRs)
time frame: At 3 month intervals from 1-2 years
Long term evaluation of clinical evolution of prostate cancer
time frame: At 3 month intervals from 1-2 years
All causes of mortality
time frame: At 3 month intervals from 1-2 years
Compare incidence of risks of adverse events (AEs)
time frame: At 6 month intervals from 3-5 years
Number and classification of new adverse drug reactions (ADRs)
time frame: At 6 month intervals from 3-5 years
Long term evaluation of clinical evolution of prostate cancer
time frame: At 6 month intervals from 3-5 years
All causes of mortality
time frame: At 6 month intervals from 3-5 years

Eligibility Criteria

Male participants of any age.

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.

Additional Information

Official title A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With Firmagon (Degarelix) on a GnRH Agonist
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ferring Pharmaceuticals.