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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02230059

CR100943

212082PCR0001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 382 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

382 participants in 1 patient group

Metastatic Castration-resistant Prostate Cancer

Description:

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

Treatment:

Other: No Intervention