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


N/A
18 Years
N/A
Open (Enrolling)
Male
Advanced Hormone Dependent Prostate Cancer

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Trial Information

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


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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)

Outcome Description:

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)

Outcome Time Frame:

During 3 years treatment

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

000036

NCT ID:

NCT01861236

Start Date:

March 2013

Completion Date:

December 2017

Related Keywords:

  • Advanced Hormone Dependent Prostate Cancer
  • Carcinoma
  • Prostatic Neoplasms

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