Clinical trial NCT01071915: Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
Official title: An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean 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
Collaborators: name: Ferring Pharmaceuticals Korea, Ltd.
First posted: 2010-02-19
Enrollment: 157
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
timeFrame: Day 28 to Day 196
Secondary outcomes:
measure: Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
timeFrame: At day 3
measure: Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
timeFrame: To Day 28
measure: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
timeFrame: Day 56 to Day 196
measure: Cumulative Probability of no PSA Failure From Day 28 to Day 196
timeFrame: To Day 196
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: To Day 196
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: To Day 196
Other outcomes:
Locations:
city: Pyungchon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyunggi-do
city: Mulgeum-eup
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyungnam
city: Daegu
country: Korea, Republic of
facility: Kyoungbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System (Sevrance Hospital)
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Gangnam Sevrance
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: