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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix; Drug: Goserelin

• Registration Number: NCT01744366
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 285

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

• 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)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, 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

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

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