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A Study of Degarelix in Patients With Prostate Cancer - NCT00928434-(Clinical Trial 299824)



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City:  Spokane
State:  
WA
Zip Code:
Conditions: Prostate Cancer
Purpose: The purpose is to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) will show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
Study summary:
Criteria: 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 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 previously participated in any Degarelix trial. - Is part of an ongoing trial.
Study is available at: Roger D. Fincher, PS
Spokane, WA
United States

Primary Contact:
Clinical Development Support
Email: DK0-Disclosure@ferring.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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