Status:
COMPLETED
A Trial of Degarelix in Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prost...
Eligibility Criteria
Inclusion
- 18 years or older.
- Has a histological confirmed prostate cancer Gleason graded).
- Has a screening testosterone above 2.2 ng/mL.
- Rising prostate-specific antigen (PSA).
- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
- Has a life expectancy of at least one year.
Exclusion
- Current or previous hormone therapy.
- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Has a heart insufficiency.
- Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
- 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 Investigator.
- Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT00946920
Start Date
June 1 2009
End Date
March 1 2011
Last Update
June 2 2014
Active Locations (126)
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1
Urology Centers Of Alabama
Homewood, Alabama, United States
2
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