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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Orléans, France
    • Hopital de la Source (there may be multiple sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients will be enrolled by urologists in private clinics or hospital clinics.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Degarelix	Drug: Degarelix; Injection; Other Names: Firmagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of cardiovascular comorbidity	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)	At inclusion

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 000235