Phase 2
Completed N=129
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
Source: ClinicalTrials.gov NCT00819247 ↗Enrolled (actual)
129
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Number of Participants With Testosterone <0.5 Nanogram/Milliliter — 38; 32; 27; 38 participants
Summary
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Testosterone <0.5 Nanogram/Milliliter |
38; 32; 27; 38; 36; 33 | — |
| SECONDARY Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 |
28; 27; 20 | — |
| SECONDARY Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 |
29; 29; 25 | — |
| SECONDARY Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Normal Prostate-specific Antigen Levels During the Study |
18; 18; 16; 18; 18; 17 | — |
| SECONDARY The Number of Participants With Abnormal Liver Function Tests |
13; 14; 12; 0; 1; 1 | — |
| SECONDARY Percentage Change in Vital Signs and Body Weight |
0.0; -0.6; 0.0; -3.7; -2.4; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent before any trial related activity
- Proven prostate cancer with a need for endocrine treatment
- Testosterone level within the normal range for the age
Exclusion Criteria
- Previous or current hormonal treatment of prostate cancer
- Candidate for prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions or Quincke's Oedema
- Hypersensitivity towards any component of FE200486
- Cancer disease within the last ten years except for prostate cancer and some skin cancers
- Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- Mental incapacity or language barrier
- Having received an investigational product within the last 12 weeks preceding the trial
- Previous participation in this trial
Data sourced from ClinicalTrials.gov (NCT00819247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.