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Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02229253
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.

Condition or disease Intervention/treatment
Advanced Hormone Sensitive Prostate Cancer Drug: degarelix

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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Group/Cohort Intervention/treatment
Degarelix
Treatment according to standard clinical practice.
Drug: degarelix
Other Name: Firmagon®




Primary Outcome Measures :
  1. Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from prostate cancer patients in a hospital setting, meeting the inclusion criteria.
Criteria

Inclusion Criteria:

  • Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer

Exclusion Criteria:

  • Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
  • Planned intermittent or short-term (< 12 months) degarelix treatment
  • Planned addition of, or switch to another form of androgen deprivation therapy during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229253


Locations
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Netherlands
Groene Hart Ziekenhuis (there may be other sites in this country)
Gouda, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02229253     History of Changes
Other Study ID Numbers: 000171
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases