Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193645
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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
Prostate Cancer Drug: Degarelix

Layout table for study information
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 : June 27, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix

Group/Cohort Intervention/treatment
Degarelix Drug: Degarelix
Injection
Other Name: Firmagon




Primary Outcome Measures :
  1. Occurrence of cardiovascular comorbidity [ Time Frame: 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate gland required.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be enrolled by urologists in private clinics or hospital clinics.
Criteria

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.

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): NCT03193645


Locations
Layout table for location information
France
Hopital de la Source (there may be multiple sites in this country)
Orléans, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Global Clinical Compliance Ferring Pharmaceuticals

Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03193645     History of Changes
Other Study ID Numbers: 000235
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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