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

Advanced Hormone Dependent Prostate Cancer Clinical Trial

— FAST AR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861236
• Other study ID #: 000036
• Status: Completed
• Start date: March 2013
• Est. completion date: September 3, 2018

Study information

• Verified date: October 2018
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Hormone Dependent Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Firmagon® (degarelix)
Monthly subcutaneous injections

Locations

Country	Name	City	State
Argentina	Hospital de Trauma y Emergencia Dr Federico Abete	Ingeniero Pablo Nogués	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The 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)	During 3 years treatment