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An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months


Degarelix was not FDA regulated at the time of the trial. After completion of the trial
degarelix has been approved by the FDA and is thus an FDA regulated intervention.


Inclusion Criteria:



- Written informed consent prior to any study related procedures

- Proven prostate cancer in need for endocrine treatment, except for neoadjuvant
hormonal therapy, but including patients with a rising PSA further to prostatectomy
or radiotherapy

- ECOG score to be equal to or above 2

- Testosterone level within age-specific normal range

- PSA value equal to or above 2 ng/ml

- Life expectancy of at least 6 months

Exclusion Criteria:

- Previous or current hormonal treatment of prostate cancer

- Recent or current treatment with any drugs modifying the testosterone level

- Candidate for curative treatment such as prostatectomy or radiotherapy

- History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or
Quincke's Oedema

- Hypersensitivity towards any component of degarelix or mannitol

- Cancer disease within the last 5 years except for prostate cancer and some skin
cancers

- Signs of liver impairment shown as elevated serum ALT or serum bilirubin

- Known hepatic disease

- Other laboratory abnormalities that judged by the investigator would interfere with
the patients participation in the trial or the evaluation of the trial results

- Clinically significant disorder including excessive alcohol or drug abuse that may
interfere with trial participation or influence the conclusion of the trial as judged
by the investigator

- Mental incapacity or language barrier precluding adequate understanding or
cooperation

- Having received an investigational product within the last 12 weeks preceding the
trial

- Previous participation in this trial

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364

Outcome Description:

Number of patients who achieved a testosterone level considered a castration level.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Russia: FSI Scientific Center of Expertise of Medical Application

Study ID:

FE200486 CS12

NCT ID:

NCT00819156

Start Date:

February 2004

Completion Date:

September 2005

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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