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DUO: Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03193645
Collaborator
(none)
150
Enrollment
1
Location
19.2
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The DUO study's main objective is to evaluate, in the real life, the prevalence of cardiovascular risk in patients with prostate cancer that hormone treatment of androgen suppression by Degarelix was introduced.

This study will also assess, at the initiation of therapy, the prevalence of osteoporosis, metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate cancer.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix (DUO)
Actual Study Start Date :
Jun 27, 2017
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jan 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Degarelix

Drug: Degarelix
Injection
Other Names:
  • Firmagon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of cardiovascular comorbidity [At inclusion]

      Measured by a history of at least one cardiovascular illness (according to ICD-10) and/or at least three cardiovascular risk factors (as defined by Cancer Committee of the French Urology Association)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male aged 18 years or older

    • Diagnosed with prostate cancer

    • Patient having received an antagonist of GnRH Degarelix prescription.

    • Agreeing to and capable of completing in French during the visits all questionnaires on the impact of their illness and treatment.

    • Patients having received oral and written study information, agreeing to the use of his anonymized data, and having signed a written Informed Consent Form.

    Exclusion Criteria:

    • Patient included in an interventional study assessing treatment for prostate cancer.

    • Patient presenting hypersensitivity to Degarelix or one of its excipients.

    • Patient treated by other hormonotherapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital de la Source (there may be multiple sites in this country) Orléans France

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03193645
    Other Study ID Numbers:
    • 000235
    First Posted:
    Jun 21, 2017
    Last Update Posted:
    Feb 26, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Feb 26, 2019