| December 2, 2008 |
| September 7, 2009 |
| December 2008 |
| November 2012 (final data collection date for primary outcome measure) |
| Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00801242 on ClinicalTrials.gov Archive Site |
- Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer |
| An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy |
The purpose of this trial is to see how well a new trial drug (degarelix) works and how safe it is when given for 7 months. For patients participating, their level of PSA (prostate specific antigen) will be measured in a blood sample, and when this level rises above a certain level they will receive treatment for the prostate cancer again. The patients will come to the clinic at monthly intervals for the first 7 months and after this they will be followed bi-monthly for a period of up to 24 months. |
| |
| Phase III |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Prostate Cancer |
| Drug: degarelix |
| |
| |
| |
| Recruiting |
| 200 |
| January 2013 |
| November 2012 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Has given written informed consent before any trial-related activity is performed.
- Has prostate cancer, and is in need of this type of treatment.
Exclusion Criteria:
- Has had previous or is currently under hormonal treatment of prostate cancer.
- Is considered to be candidate for radical prostatectomy or radiotherapy.
- Has a history of severe uncontrolled asthma and/or other severe allergic reactions.
- Has hypersensitivity towards any component of degarelix.
- Has had cancer within the last five years except prostate cancer and some types of skin cancer.
- Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.
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| Male |
| 18 Years and older |
| No |
|
|
| Belgium, France, Germany, Italy, Netherlands, Spain |
| |
| NCT00801242 |
| Hjort, Director, Ferring Pharmaceuticals |
| FE200486 CS29, EudraCT No: 2008-003931-19 |
| Ferring Pharmaceuticals |
|
| Study Director: |
Clinical Development Support |
Ferring Pharmaceuticals |
|
|
| Ferring Pharmaceuticals |
| September 2009 |