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Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany

NCT ID: NCT02450812

Last Updated: 2021-11-02

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

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-28

Study Completion Date

2020-09-17

Brief Summary

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This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.

Detailed Description

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Conditions

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Prostatic Neoplasms, Castration-Resistant

Keywords

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mCRPC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Radium-223-dichloride (Xofigo, BAY88-8223)

patients with mCRPC with symptomatic bone metastases

Radium-223-dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

according to Summary of Product Characteristics

Interventions

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Radium-223-dichloride (Xofigo, BAY88-8223)

according to Summary of Product Characteristics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases
* Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

Exclusion Criteria

-Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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XF 1503

Identifier Type: OTHER

Identifier Source: secondary_id

EUPAS24796

Identifier Type: OTHER

Identifier Source: secondary_id

18043

Identifier Type: -

Identifier Source: org_study_id