Phase 3
Completed N=620
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Source: ClinicalTrials.gov NCT00451958 ↗Enrolled (actual)
620
Serious AEs
27.2%
Results posted
Mar 2013
Primary outcomePrimary: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight — 3; 6; 3; 6 participants
Summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
3; 6; 3; 6; 3; 6 | — |
| PRIMARY Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables |
11; 9; 6; 5; 1; 6 | — |
| SECONDARY Percentage of Participants With no Prostate-specific Antigen (PSA) Progression |
100; 99.5; 98.6; 100; 91.1; 85.8 | — |
| SECONDARY Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards |
99.5; 100; 98.6; 97.6; 97.2; 98.3 | — |
| SECONDARY Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 |
0.076; 0.074; 0.084; 0.068; 0.076; 0.066 | — |
| SECONDARY Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 |
0.4; 0.4; 0.4; 0.3; 0.35; 0.4 | — |
| SECONDARY Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 |
0.035; 0.035; 0.035; 0.035; 0.035; 0.035 | — |
| SECONDARY Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 |
4.8; 4.4; 2.7; 2.8; 2.6; 2.6 | — |
Eligibility Criteria
Inclusion/Exclusion Criteria:
- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Signed informed consent
- The patients must have completed the FE 200486 CS21 Study.
Data sourced from ClinicalTrials.gov (NCT00451958). 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.