A Study of Degarelix in Patients With Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: June 25, 2009
Last updated: September 24, 2012
Last verified: September 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
Primary Outcome Measures:
- PSA [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1. Reported Outcome Quality of Life intermittent treatment & continuous treatment [ Time Frame: Phase A Visit 1-7. Phase B Visit 8-15. ] [ Designated as safety issue: No ]
- 2. PSA [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Experimental: A. DI (Degarelix Intermittent)
Experimental: B. DC (Degarelix Continuous)
Active Comparator: C. LC (Leuprolide Continuous)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928434
||Clinical Development Support
No publications provided
History of Changes
|Other Study ID Numbers:
||FE200486 CS37, RISPSA
|Study First Received:
||June 25, 2009
||September 24, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs