One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
- Registration Number
- NCT01744366
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
One month degarelix/comparator treatment for prostate cancer in Chinese population
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 285
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix Degarelix Degarelix 240/80 mg Goserelin Goserelin Goserelin 3.6 mg
- Primary Outcome Measures
Name Time Method Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) Day 28 to Day 364
- Secondary Outcome Measures
Name Time Method Proportion of patients with testosterone levels ≤0.5 ng/mL at Day 3 Percentage change in prostate-specific antigen (PSA) from baseline to Day 28 Changes in testosterone and PSA levels Day 0 to 364 Significant changes in laboratory values Day 0 to Day 364 Significant changes in vital signs Day 0 to Day 364 Significant changes in body weight Day 0 to Day 364 Frequency and severity of adverse events Day 0 to Day 364 Cumulative probability of no PSA failure Day 0 to Day 364 PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir
Trial Locations
- Locations (29)
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
🇨🇳Chongqing, Chongqing, China
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
🇨🇳Xi'an, Shanxi, China
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
1st Afilliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
2nd Hospital Affiliated to Suzhou University
🇨🇳Suzhou, China
2nd Hospital of Tianjin Medical University
🇨🇳Tianjin, China
Peking University People's Hospital
🇨🇳Beijing, China
Peking Union Hospital
🇨🇳Beijing, China
People's Hospital of Sichuan
🇨🇳Chengdu, China
Beijing Hospital of Ministry of Health
🇨🇳Beijing, China
Hunan Province People's Hospital
🇨🇳Changsha, China
Peking University 3rd Hospital
🇨🇳Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, China
1st Hospital of Jilin University
🇨🇳Changchun, China
2nd Hospital Affiliated to Zhejiang University Medical School
🇨🇳Hangzhou, China
1st Hospital of Lanzhou University
🇨🇳Lanzhou, China
1st Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
1st Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanghai 5th People's Hospital affilicated to Fudan University
🇨🇳Shanghai, China
Shanghai Changhai Hospital
🇨🇳Shanghai, China
Huashan Hospital of Fudan University
🇨🇳Shanghai, China
1st Hospital Affiliated to China Medical University
🇨🇳Shenyang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
1st People's Hospital of Wuxi
🇨🇳Wuxi, China
1st Hospital Affiliated to Zhejiang University Medical School
🇨🇳Hangzhou, Zhejiang, China
Drum Tower Hospital Affiliated to Nanjing University Medical School
🇨🇳Nanjing, China