Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC)

NCT ID: NCT02230059

Last Updated: 2014-09-25

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

382 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to assess the treatment patterns in participants with metastatic castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall survival will be observed.

Detailed Description

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This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes), longitudinal (correlational research study that involves repeated observations of the same variables over long periods of time) and retrospective (study looking back over past experience) study to describe the treatment patterns in mCRPC. Treatment patterns will be assessed by collecting medical charts from participants diagnosed with mCRPC in or prior 2009. Primarily, percentage of participants who received therapy as first line treatment will be assessed. All adverse events associated with the use of Sponsor drugs will be reported.

Conditions

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Prostatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Metastatic Castration-resistant Prostate Cancer

Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

No Intervention

Intervention Type OTHER

Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Interventions

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No Intervention

Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Report of previous surgical or medical castration
* Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging in or before 2009. If lymph node metastasis is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter

Exclusion Criteria

* Participation in any investigational drug or device study or early access programme
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Brasília, , Brazil

Site Status

Curitiba, , Brazil

Site Status

Distrito Federal, , Brazil

Site Status

Florianópolis, , Brazil

Site Status

Goiânia, , Brazil

Site Status

Ijuí, , Brazil

Site Status

Jaú, , Brazil

Site Status

Porto Alegre, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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212082PCR0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100943

Identifier Type: -

Identifier Source: org_study_id

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