Clinical trial NCT01744366: One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
Official title: An Open-label, Multi-centre, Randomised, Parallel-group Trial, Comparing Efficacy and Safety of Degarelix One-month Dosing Regimen With Goserelin in Chinese 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: 2012-12-06
Enrollment: 285
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One month degarelix/comparator treatment for prostate cancer in Chinese population


Eligibility criteria: Inclusion Criteria:

* Chinese male over 18 years
* Adenocarcinoma of the prostate
* Relevant disease status based on lab values and as judged by the physician
* Life expectancy of at least a year

Exclusion Criteria:

* Previous hormonal treatment for prostate cancer
* Considered to be candidate for curative therapy
* Risk or history of any serious or significant health condition
* Has received an investigational drug within the last 28 days and no previous treatment with degarelix

Primary outcomes:
measure: Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
timeFrame: Day 28 to Day 364
Secondary outcomes:
measure: Proportion of patients with testosterone levels ≤0.5 ng/mL
timeFrame: at Day 3
measure: Percentage change in prostate-specific antigen (PSA)
timeFrame: from baseline to Day 28
measure: Changes in testosterone and PSA levels
timeFrame: Day 0 to 364
measure: Significant changes in laboratory values
timeFrame: Day 0 to Day 364
measure: Significant changes in vital signs
timeFrame: Day 0 to Day 364
measure: Significant changes in body weight
timeFrame: Day 0 to Day 364
measure: Frequency and severity of adverse events
timeFrame: Day 0 to Day 364
measure: Cumulative probability of no PSA failure
timeFrame: Day 0 to Day 364
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital. Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
state: Chongqing
city: Guangzhou
country: China
facility: 1st Afilliated Hospital of Guangzhou Medical College
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Xi'an
country: China
facility: 2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
state: Shanxi
city: Hangzhou
country: China
facility: 1st Hospital Affiliated to Zhejiang University Medical School
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health
city: Beijing
country: China
facility: Peking Union Hospital
city: Beijing
country: China
facility: Peking University 3rd Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: 1st Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Hunan Province People's Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan
city: Hangzhou
country: China
facility: 2nd Hospital Affiliated to Zhejiang University Medical School
city: Lanzhou
country: China
facility: 1st Hospital of Lanzhou University
city: Nanchang
country: China
facility: 1st Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: 1st Affiliated Hospital of Nanjing Medical University
city: Nanjing
country: China
facility: Drum Tower Hospital Affiliated to Nanjing University Medical School
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai 5th People's Hospital affilicated to Fudan University
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shenyang
country: China
facility: 1st Hospital Affiliated to China Medical University
city: Suzhou
country: China
facility: 2nd Hospital Affiliated to Suzhou University
city: Tianjin
country: China
facility: 2nd Hospital of Tianjin Medical University
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Wuxi
country: China
facility: 1st People's Hospital of Wuxi
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.