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Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01861236
Acronym
FAST AR
Enrollment
90
Registered
2013-05-23
Start date
2013-03-31
Completion date
2018-09-03
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hormone Dependent Prostate Cancer

Brief summary

Prospective, observational study to collect and analyze data on patients with advanced hormone dependent prostate cancer treated with Firmagon® according to routine medical practice in Argentina

Interventions

DRUGFirmagon® (degarelix)

Monthly subcutaneous injections

Sponsors

Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Advanced Prostate Cancer patients to be treated with Firmagon in the context of usual clinical practice * Written informed consent

Exclusion criteria

* Contraindications to Firmagon * Patients already on Firmagon therapy

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death)During 3 years treatmentThe PFS failure rate will be estimated with time to PFS failure as dependent and adjusting for disease stage at baseline, baseline PSA, baseline testosterone (if available) and baseline serum Alkaline Phosphatase (s-ALP, if available)

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026