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A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

Phase 3
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

Inclusion Criteria:

- 18 years or older.

- Raising PSA after prior treatment failure of localized prostate cancer.

- Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded)
based on the most current biopsy.

- Has a screening testosterone with-in normal range ≥1.5 ng/mL.

- Has ECOG score of ≤2.

- CT scan, MRI or bone scan report documenting no evidence of metastasis to the bone or
internal organs.

- Life expectancy of at least 15 months.

Exclusion Criteria:

- Taken hormone therapy in the last 6 months prior to entering this study.

- Has a history of sever uncontrolled asthma, anaphylactic reactions, or sever
urticaria and/or angioedema.

- Has hypersensitivity towards any component of the study drug.

- Has a previous history or presence of another malignancy other than prostate cancer
or treated squamous/basel cell carcinoma of the skin within the last five years.

- Abnormal laboratory results which in the judgement of the Investigator would affect
the patient's health or the outcome of the trial.

- Has a clinically significant medical condition (other than prostate cancer) including
but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac,
neurological or psychiatric disease and alcohol or drug abuse or any other condition
which may affect the patient's health or the outcome of the trial as judged by the

- Has an intellectual incapacity or language barriers precluding adequate understanding
or co-operation.

- Has received an investigational drug within the last 28 days before the Screening
visit or longer if considered to possibly influence the outcome of the current trial.

- Has previously participated in any Degarelix trial.

- Is part of an ongoing trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:


Safety Issue:


Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals


United States: Food and Drug Administration

Study ID:

FE200486 CS37



Start Date:

May 2009

Completion Date:

September 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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