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

NCT03193645 | Completed

• 1 other identifier: 000235
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Degarelix

Drug: Degarelix

Interventions

Degarelix DRUG

Injection

Also known as: Firmagon

Degarelix

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate gland required.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Hopital de la Source (there may be multiple sites in this country)

Orléans, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: June 27, 2017
• Primary Completion: June 30, 2018
• Study Completion: January 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

FR (1)