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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744366
• Other study ID #: 000006
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2012
• Last updated: June 22, 2015
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

• Goserelin

Locations

Country	Name	City	State
China	Beijing Hospital of Ministry of Health	Beijing
China	Cancer Institute & Hospital. Chinese Academy of Medical Sciences	Beijing	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	Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army	Chongqing	Chongqing
China	1st Afilliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	1st Hospital Affiliated to Zhejiang University Medical School	Hangzhou	Zhejiang
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	Renmin Hospital of Wuhan University	Wuhan	Hubei
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	2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative probability of testosterone at castrate level (=0.5 ng/mL)		Day 28 to Day 364	No
Secondary	Proportion of patients with testosterone levels =0.5 ng/mL		at Day 3	No
Secondary	Percentage change in prostate-specific antigen (PSA)		from baseline to Day 28	No
Secondary	Changes in testosterone and PSA levels		Day 0 to 364	No
Secondary	Significant changes in laboratory values		Day 0 to Day 364	Yes
Secondary	Significant changes in vital signs		Day 0 to Day 364	Yes
Secondary	Significant changes in body weight		Day 0 to Day 364	Yes
Secondary	Frequency and severity of adverse events		Day 0 to Day 364	Yes
Secondary	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	Day 0 to Day 364	No