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

Janssen Research & Development, LLC382 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

382

Conditions

Prostatic Neoplasms

Interventions

No InterventionOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Brasília, Brazil

Unnamed facility

Curitiba, Brazil

Unnamed facility

Distrito Federal, Brazil

Unnamed facility

Florianópolis, Brazil

Outcomes

Primary Outcomes

Percentage of Participants Treated With Chemotherapy in First Line Therapy

Participants treated with chemotherapy in first line therapy will be reported.

Time frame: Day 1

Percentage of Participants Treated With Other Therapies in First Line Therapy

Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.

Time frame: Day 1

Percentage of Participants Treated With Chemotherapy in Second Line Therapy

Participants who were treated with chemotherapy in second line therapy will be reported.

Time frame: Day 1

Percentage of Participants Treated With Other Therapies in Second Line Therapy

Time frame: Day 1

Secondary Outcomes

Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (best) to grade 5 (worst).

Time frame: Day 1

Number of Participants with Comorbidities

Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.

Time frame: Day 1

Data from ClinicalTrials.gov

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