- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01744366
One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population (PANDA)
June 22, 2015 updated by: Ferring Pharmaceuticals
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
One month degarelix/comparator treatment for prostate cancer in Chinese population
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
285
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Peking Union Hospital
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Beijing, China
- Peking University People's Hospital
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Beijing, China
- Peking University 3rd Hospital
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Beijing, China
- Beijing Hospital of Ministry of Health
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Changchun, China
- 1st Hospital of Jilin University
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Changsha, China
- Hunan Cancer Hospital
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Changsha, China
- Hunan Province People's Hospital
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Chengdu, China
- People's Hospital of Sichuan
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Hangzhou, China
- 2nd Hospital Affiliated to Zhejiang University Medical School
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Lanzhou, China
- 1st Hospital of Lanzhou University
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Nanchang, China
- 1st Affiliated Hospital of Nanchang University
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Nanjing, China
- 1st Affiliated Hospital of Nanjing Medical University
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Nanjing, China
- Drum Tower Hospital Affiliated to Nanjing University Medical School
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Shanghai, China
- Fudan University Shanghai Cancer Center
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Shanghai, China
- Shanghai Changhai Hospital
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Shanghai, China
- Huashan Hospital of Fudan University
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Shanghai, China
- Shanghai 5th People's Hospital affilicated to Fudan University
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Shenyang, China
- 1st Hospital Affiliated to China Medical University
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Suzhou, China
- 2nd Hospital Affiliated to Suzhou University
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Tianjin, China
- 2nd Hospital of Tianjin Medical University
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Wuhan, China
- Zhongnan Hospital of Wuhan University
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Wuhan, China
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Wuxi, China
- 1st People's Hospital of Wuxi
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Beijing
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Beijing, Beijing, China
- Cancer Institute & Hospital. Chinese Academy of Medical Sciences
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Chongqing
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Chongqing, Chongqing, China
- Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
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Guangdong
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Guangzhou, Guangdong, China
- 1st Afilliated Hospital of Guangzhou Medical College
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Hubei
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Wuhan, Hubei, China
- Renmin Hospital of Wuhan University
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Shanxi
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Xi'an, Shanxi, China
- 2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
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Zhejiang
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Hangzhou, Zhejiang, China
- 1st Hospital Affiliated to Zhejiang University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Degarelix
Degarelix 240/80 mg
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Active Comparator: Goserelin
Goserelin 3.6 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Time Frame: Day 28 to Day 364
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Day 28 to Day 364
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with testosterone levels ≤0.5 ng/mL
Time Frame: at Day 3
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at Day 3
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Percentage change in prostate-specific antigen (PSA)
Time Frame: from baseline to Day 28
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from baseline to Day 28
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Changes in testosterone and PSA levels
Time Frame: Day 0 to 364
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Day 0 to 364
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Significant changes in laboratory values
Time Frame: Day 0 to Day 364
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Day 0 to Day 364
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Significant changes in vital signs
Time Frame: Day 0 to Day 364
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Day 0 to Day 364
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Significant changes in body weight
Time Frame: Day 0 to Day 364
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Day 0 to Day 364
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Frequency and severity of adverse events
Time Frame: Day 0 to Day 364
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Day 0 to Day 364
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Cumulative probability of no PSA failure
Time Frame: Day 0 to Day 364
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PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir
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Day 0 to Day 364
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 5, 2012
First Submitted That Met QC Criteria
December 5, 2012
First Posted (Estimate)
December 6, 2012
Study Record Updates
Last Update Posted (Estimate)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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