A Study of Degarelix in Taiwanese Patients With Prostate Cancer
An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
1 other identifier
interventional
110
1 country
10
Brief Summary
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Dec 2010
Shorter than P25 for phase_3 prostate-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 6, 2013
CompletedApril 13, 2025
December 1, 2013
1.8 years
October 13, 2010
October 14, 2013
March 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.
From Day 28 to Day 168
Secondary Outcomes (3)
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Day 3
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
From Day 0 to Day 28
Cumulative Probability of no PSA Failure
Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168
Other Outcomes (1)
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis
From Day 28 to Day 168
Study Arms (1)
Degarelix
EXPERIMENTALInterventions
Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Changhua Christian Hospital
Changhua, Taiwan
Chang Gung Medical Foundation, Chiayi Branch
Chiayi City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi-Mei Foundation Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkuo
Taoyuan District, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 14, 2010
Study Start
December 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
April 13, 2025
Results First Posted
December 6, 2013
Record last verified: 2013-12