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OpenTrials
Completed

NCT Number: NCT01861236

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

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

Completed

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Key information

Conditions

Advanced Hormone Dependent Prostate Cancer

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Hospital de Trauma y Emergencia Dr Federico Abete

Ingeniero Pablo Nogués, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Firmagon® (degarelix)

Drug

Monthly subcutaneous injections

Primary outcomes

  1. 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)

    Time frame: During 3 years treatment

    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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Acronym: FAST AR

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 23, 2013
Registry last updated
Oct 23, 2018

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.