Status:
COMPLETED
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a ...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00819156
Start Date
February 1 2004
End Date
September 1 2005
Last Update
November 30 2023
Active Locations (39)
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1
UCL Saint Luc
Brussels, Belgium
2
UZ Gent
Ghent, Belgium
3
UZ Gasthuisberg
Leuven, Belgium
4
Vivantes Klinikum am Urban
Berlin, Germany