Phase 3
Completed N=848
A Trial of Degarelix in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00946920 ↗Enrolled (actual)
848
Serious AEs
10.7%
Results posted
Jun 2014
Primary outcomePrimary: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix — 90.0 percentage of participants
Summary
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix |
90.0 | — |
| PRIMARY Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin |
85.0; 5.3 | — |
| SECONDARY Serum Levels of Testosterone Over Time |
0.10; 0.16; 0.09; 0.10; 0.09; 0.09 | — |
| SECONDARY Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time |
-77; -57; -89; -86; -90; -86 | — |
| SECONDARY Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline |
0.52; 0.27; 0.18; -0.87 | — |
| SECONDARY Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline |
-1.06; -0.21; -2.31; -1.74; -2.47; -2.45 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Has a histological confirmed prostate cancer Gleason graded).
- Has a screening testosterone above 2.2 ng/mL.
- Rising prostate-specific antigen (PSA).
- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
- Has a life expectancy of at least one year.
Exclusion Criteria
- Current or previous hormone therapy.
- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Has a heart insufficiency.
- Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
- Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
Data sourced from ClinicalTrials.gov (NCT00946920). 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.