Phase 3
Completed N=620
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
Source: ClinicalTrials.gov NCT00295750 ↗Enrolled (actual)
620
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 — 98.3; 97.2; 96.4 percentage of patients
Summary
The study was a three-arm, active-control, multi-centre, parallel group study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 |
98.3; 97.2; 96.4 | — |
| SECONDARY Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment |
0.5; 0.0; 80.1 | <0.0001 sig |
| SECONDARY Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 |
95.5; 96.1; 0 | <0.0001 sig |
| SECONDARY Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 |
1; 3; 0; 84; 85; 49 | — |
| SECONDARY Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 |
-64.6; -63.4; -17.9; -82.3; -84.9; -66.7 | <0.0001 sig |
| SECONDARY Participants Grouped by Time to Prostate-specific Antigen Failure |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) |
73; 80; 73; 32; 45; 38 | — |
| SECONDARY The Mean Value of QTc Interval as Measured by Electrocardiogram |
403; 407; 404; 404; 411; 405 | — |
| SECONDARY Participants With Markedly Abnormal Change in Vital Signs and Body Weight |
12; 8; 6; 20; 16; 23 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Baseline testosterone >1.5 ng/mL.
- Life expectancy of at least 12 months.
Data sourced from ClinicalTrials.gov (NCT00295750). 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.