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Completed

NCT Number: NCT03193645

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

Orléans, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

degarelix

Drug

Injection

Other names: Firmagon

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: DUO

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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