Phase 3
Completed N=157
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT01071915 ↗Enrolled (actual)
157
Serious AEs
11.5%
Results posted
Feb 2013
Primary outcomePrimary: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 — 96.7 percent probability
Summary
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 |
96.7 | — |
| SECONDARY Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 |
97.4 | — |
| SECONDARY Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 |
-79.7 | — |
| SECONDARY Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 |
96.7 | — |
| SECONDARY Cumulative Probability of no PSA Failure From Day 28 to Day 196 |
97.3 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables |
73; 5; 1; 1; 19; 1 | — |
| SECONDARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
6; 0; 12; 1; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has given written informed consent before any trial-related activity is performed.
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
- Is a male patient aged 18 years or older
- Has a screening serum testosterone level >1.5 ng/mL
- Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
- Has a screening PSA value of ≥2 ng/mL
- Has a life expectancy of at least 12 months
Exclusion Criteria
- Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
- Is currently treated with a 5-α-reductase inhibitor
- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- Has hypersensitivity towards any component of the investigational medicinal product
- A marked baseline prolongation of QT/QTcF interval
- A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
- Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
- Has a known or suspect hepatic, symptomatic biliary disease
- Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
- Has other clinically significant laboratory abnormalities
- Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
- Has a mental incapacity or language barriers precluding adequate understanding or co- operation
- Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
- Has previously participated in any degarelix trial
Data sourced from ClinicalTrials.gov (NCT01071915). 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.