Phase 2
Completed N=133
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Source: ClinicalTrials.gov NCT00468286 ↗Enrolled (actual)
133
Serious AEs
13.5%
Results posted
Mar 2011
Primary outcomePrimary: Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 — 89.0; 93.3 percentage of participants
Summary
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 |
89.0; 93.3 | — |
| SECONDARY Serum Levels of Testosterone Over Time |
0.1; 0.1; 0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364 |
89.0; 93.3 | — |
| SECONDARY Probability of no PSA Failure |
93.5; 94.6 | — |
| SECONDARY Serum Levels of PSA Over Time |
3.5; 3.1; 1.2; 1.2; 0.4; 0.7 | — |
| SECONDARY Serum Levels of Follicle Stimulating Hormone (FSH) Over Time |
0.3; 0.4; 0.6; 0.5; 1.6; 1.0 | — |
| SECONDARY Serum Levels of Luteinizing Hormone (LH) Over Time |
0.1; 0.1; 0.1; 0.1; 0.3; 0.2 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Liver Function Tests |
22; 21; 33; 23; 3; 1 | — |
Eligibility Criteria
Inclusion / Exclusion Criteria:
- Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- Eastern Cooperative Oncology Group (ECOG) score of ≤2.
- Screening prostate-specific antigen (PSA) level ≥ ng/mL.
Data sourced from ClinicalTrials.gov (NCT00468286). 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.