Prostate Cancer Clinical Trial
— DUOOfficial title:
Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix (DUO)
NCT number | NCT03193645 |
Other study ID # | 000235 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 27, 2017 |
Est. completion date | January 31, 2019 |
Verified date | February 2019 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 31, 2019 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Hopital de la Source (there may be multiple sites in this country) | Orléans |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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