Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )

NCT ID: NCT02899104

Last Updated: 2020-03-31

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-03-31

Brief Summary

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Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

Detailed Description

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This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

Conditions

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Prostatic Neoplasms, Castration-Resistant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radium-223 dichloride

Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223.

Xofigo (Radium-223 dichloride, BAY88-8223)

Intervention Type DRUG

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Interventions

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Xofigo (Radium-223 dichloride, BAY88-8223)

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
* Patients were at least 18 years of age as of the first diagnosis for mCRPC.
* Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
* First injection of Radium-223 must have started between periods

1-January-2014 to 30-June-2014 or 15-November-2014 to present.
* Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.

Exclusion Criteria

* Patients who received Radium-223 as part in an interventional clinical trial
* Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
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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Whippany

Whippany, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18919

Identifier Type: -

Identifier Source: org_study_id

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