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One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population (PANDA)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Degarelix
Goserelin
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute & Hospital. Chinese Academy of Medical Sciences
  • Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
  • 1st Afilliated Hospital of Guangzhou Medical College
  • Renmin Hospital of Wuhan University
  • 2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
  • 1st Hospital Affiliated to Zhejiang University Medical School
  • Beijing Hospital of Ministry of Health
  • Peking Union Hospital
  • Peking University 3rd Hospital
  • Peking University People's Hospital
  • 1st Hospital of Jilin University
  • Hunan Cancer Hospital
  • Hunan Province People's Hospital
  • People's Hospital of Sichuan
  • 2nd Hospital Affiliated to Zhejiang University Medical School
  • 1st Hospital of Lanzhou University
  • 1st Affiliated Hospital of Nanchang University
  • 1st Affiliated Hospital of Nanjing Medical University
  • Drum Tower Hospital Affiliated to Nanjing University Medical School
  • Fudan University Shanghai Cancer Center
  • Huashan Hospital of Fudan University
  • Shanghai 5th People's Hospital affilicated to Fudan University
  • Shanghai Changhai Hospital
  • 1st Hospital Affiliated to China Medical University
  • 2nd Hospital Affiliated to Suzhou University
  • 2nd Hospital of Tianjin Medical University
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Zhongnan Hospital of Wuhan University
  • 1st People's Hospital of Wuxi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Degarelix

Goserelin

Arm Description

Degarelix 240/80 mg

Goserelin 3.6 mg

Outcomes

Primary Outcome Measures

Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)

Secondary Outcome Measures

Proportion of patients with testosterone levels ≤0.5 ng/mL
Percentage change in prostate-specific antigen (PSA)
Changes in testosterone and PSA levels
Significant changes in laboratory values
Significant changes in vital signs
Significant changes in body weight
Frequency and severity of adverse events
Cumulative probability of no PSA failure
PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir

Full Information

First Posted
December 5, 2012
Last Updated
June 22, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01744366
Brief Title
One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
Acronym
PANDA
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Arm Description
Degarelix 240/80 mg
Arm Title
Goserelin
Arm Type
Active Comparator
Arm Description
Goserelin 3.6 mg
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Type
Drug
Intervention Name(s)
Goserelin
Primary Outcome Measure Information:
Title
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Time Frame
Day 28 to Day 364
Secondary Outcome Measure Information:
Title
Proportion of patients with testosterone levels ≤0.5 ng/mL
Time Frame
at Day 3
Title
Percentage change in prostate-specific antigen (PSA)
Time Frame
from baseline to Day 28
Title
Changes in testosterone and PSA levels
Time Frame
Day 0 to 364
Title
Significant changes in laboratory values
Time Frame
Day 0 to Day 364
Title
Significant changes in vital signs
Time Frame
Day 0 to Day 364
Title
Significant changes in body weight
Time Frame
Day 0 to Day 364
Title
Frequency and severity of adverse events
Time Frame
Day 0 to Day 364
Title
Cumulative probability of no PSA failure
Description
PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir
Time Frame
Day 0 to Day 364

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
1st Afilliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
1st Hospital Affiliated to Zhejiang University Medical School
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Hospital of Ministry of Health
City
Beijing
Country
China
Facility Name
Peking Union Hospital
City
Beijing
Country
China
Facility Name
Peking University 3rd Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
1st Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
Hunan Province People's Hospital
City
Changsha
Country
China
Facility Name
People's Hospital of Sichuan
City
Chengdu
Country
China
Facility Name
2nd Hospital Affiliated to Zhejiang University Medical School
City
Hangzhou
Country
China
Facility Name
1st Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
1st Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
1st Affiliated Hospital of Nanjing Medical University
City
Nanjing
Country
China
Facility Name
Drum Tower Hospital Affiliated to Nanjing University Medical School
City
Nanjing
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Shanghai 5th People's Hospital affilicated to Fudan University
City
Shanghai
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Facility Name
1st Hospital Affiliated to China Medical University
City
Shenyang
Country
China
Facility Name
2nd Hospital Affiliated to Suzhou University
City
Suzhou
Country
China
Facility Name
2nd Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
1st People's Hospital of Wuxi
City
Wuxi
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34350976
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.
Results Reference
derived

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One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population

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