Status:
COMPLETED
A Study of Degarelix in Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen depriva...
Detailed Description
This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment...
Eligibility Criteria
Inclusion
- 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 within normal range (≥1.5 ng/mL).
- Has Eastern Cooperative Oncology Group score of ≤2.
- Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
- Life expectancy of at least 15 months.
Exclusion
- Taken hormone therapy in the last 6 months prior to entering this study.
- Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
- Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe 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/basal cell carcinoma of the skin within the last five years.
- Has 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 Investigator.
- 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 received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
- Has previously participated in any Degarelix trial.
- Is part of an ongoing trial.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00928434
Start Date
May 1 2009
End Date
August 1 2012
Last Update
December 13 2016
Active Locations (59)
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1
Alabama Clinical Research, Inc
Alexander City, Alabama, United States
2
Urology Center of Alabama, PC
Homewood, Alabama, United States
3
Advanced Urology Medical Center
Anaheim, California, United States
4
Peninsula Urology Medical Center
Atherton, California, United States