One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
PANDA
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
1 other identifier
interventional
285
1 country
29
Brief Summary
One month degarelix/comparator treatment for prostate cancer in Chinese population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Jan 2013
Shorter than P25 for phase_3 prostate-cancer
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 23, 2015
June 1, 2015
2.3 years
December 5, 2012
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Day 28 to Day 364
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
Degarelix
EXPERIMENTALDegarelix 240/80 mg
Goserelin
ACTIVE COMPARATORGoserelin 3.6 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
Chongqing, Chongqing Municipality, China
1st Afilliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, China
1st Hospital Affiliated to Zhejiang University Medical School
Hangzhou, Zhejiang, China
Beijing Hospital of Ministry of Health
Beijing, China
Peking Union Hospital
Beijing, China
Peking University 3rd Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
1st Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Hunan Province People's Hospital
Changsha, China
People's Hospital of Sichuan
Chengdu, 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
Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Huashan Hospital of Fudan University
Shanghai, China
Shanghai 5th People's Hospital affilicated to Fudan University
Shanghai, China
Shanghai Changhai Hospital
Shanghai, China
1st Hospital Affiliated to China Medical University
Shenyang, China
2nd Hospital Affiliated to Suzhou University
Suzhou, China
2nd Hospital of Tianjin Medical University
Tianjin, 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
Related Publications (1)
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.
PMID: 34350976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2012
First Posted
December 6, 2012
Study Start
January 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06