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

NCT ID: NCT01744366

Last Updated: 2015-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Degarelix

Degarelix 240/80 mg

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Goserelin

Goserelin 3.6 mg

Group Type ACTIVE_COMPARATOR

Goserelin

Intervention Type DRUG

Interventions

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Degarelix

Intervention Type DRUG

Goserelin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army

Chongqing, Chongqing Municipality, China

Site Status

1st Afilliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine

Xi’an, Shanxi, China

Site Status

1st Hospital Affiliated to Zhejiang University Medical School

Hangzhou, Zhejiang, China

Site Status

Beijing Hospital of Ministry of Health

Beijing, , China

Site Status

Peking Union Hospital

Beijing, , China

Site Status

Peking University 3rd Hospital

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

1st Hospital of Jilin University

Changchun, , China

Site Status

Hunan Cancer Hospital

Changsha, , China

Site Status

Hunan Province People's Hospital

Changsha, , China

Site Status

People's Hospital of Sichuan

Chengdu, , China

Site Status

2nd Hospital Affiliated to Zhejiang University Medical School

Hangzhou, , China

Site Status

1st Hospital of Lanzhou University

Lanzhou, , China

Site Status

1st Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

1st Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status

Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Huashan Hospital of Fudan University

Shanghai, , China

Site Status

Shanghai 5th People's Hospital affilicated to Fudan University

Shanghai, , China

Site Status

Shanghai Changhai Hospital

Shanghai, , China

Site Status

1st Hospital Affiliated to China Medical University

Shenyang, , China

Site Status

2nd Hospital Affiliated to Suzhou University

Suzhou, , China

Site Status

2nd Hospital of Tianjin Medical University

Tianjin, , China

Site Status

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status

Zhongnan Hospital of Wuhan University

Wuhan, , China

Site Status

1st People's Hospital of Wuxi

Wuxi, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34350976 (View on PubMed)

Other Identifiers

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000006

Identifier Type: -

Identifier Source: org_study_id

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