Clinical trial NCT01220869: A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 110
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
timeFrame: From Day 28 to Day 168
Secondary outcomes:
measure: Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
timeFrame: Day 3
measure: Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
timeFrame: From Day 0 to Day 28
measure: Cumulative Probability of no PSA Failure
timeFrame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168
Other outcomes:
measure: Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis
timeFrame: From Day 28 to Day 168
Locations:
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi
country: Taiwan
facility: Chang Gung Medical Foundation, Chiayi Branch
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Foundation Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkuo
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: