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An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy


Inclusion Criteria:



- Has given written informed consent before any trial-related activity is performed.

- Has prostate cancer, and is in need of this type of treatment.

Exclusion Criteria:

- Has had previous or is currently under hormonal treatment of prostate cancer.

- Is considered to be candidate for radical prostatectomy or radiotherapy.

- Has a history of severe uncontrolled asthma and/or other severe allergic reactions.

- Has hypersensitivity towards any component of degarelix.

- Has had cancer within the last five years except prostate cancer and some types of
skin cancer.

- Has a severe disorder (other than prostate cancer) including but not limited to
liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac,
neurological, or psychiatric disease, and alcohol or drug abuse or any other
condition, as judged by the investigator.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the time to PSA > 4 ng/mL

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

FE200486 CS29

NCT ID:

NCT00801242

Start Date:

December 2008

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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