Phase 3
Completed N=110
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT01220869 ↗Enrolled (actual)
110
Serious AEs
8.2%
Results posted
Dec 2013
Primary outcomePrimary: Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 — 97.2 Percentage of participants
Summary
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 |
97.2 | — |
| SECONDARY Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3 |
93.5 | — |
| SECONDARY Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 |
-92.4 | — |
| SECONDARY Cumulative Probability of no PSA Failure |
100; 100; 100; 99.1; 98.1; 96.2 | — |
Eligibility Criteria
Inclusion Criteria
- 20 years or older
- Has a histological confirmed prostate cancer
- Has a screening serum testosterone above 1.5 ng/mL
- Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
- Has a screening PSA value of ≥2 ng/mL
- Has a life expectancy of at least 168 days
Exclusion Criteria
- Current or previous hormone therapy
- Is currently treated with 5-α-reductase inhibitor
- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
- Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
- 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
Data sourced from ClinicalTrials.gov (NCT01220869). 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.