Status:
COMPLETED
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
20+ years
Phase:
PHASE3
Brief Summary
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01220869
Start Date
December 1 2010
End Date
October 1 2012
Last Update
April 13 2025
Active Locations (10)
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1
Changhua Christian Hospital
Changhua, Taiwan
2
Chang Gung Medical Foundation, Chiayi Branch
Chiayi City, Taiwan
3
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
4
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan