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

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Other: No Intervention

• Registration Number: NCT02230059
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Status Verified: 2014-09
• Study First Posted: 2014-09-03
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 382

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

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Exclusion Criteria

• Participation in any investigational drug or device study or early access programme

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic Castration-resistant Prostate Cancer	No Intervention	Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Treated With Chemotherapy in First Line Therapy	Day 1	Participants treated with chemotherapy in first line therapy will be reported.
Percentage of Participants Treated With Other Therapies in First Line Therapy	Day 1	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.
Percentage of Participants Treated With Chemotherapy in Second Line Therapy	Day 1	Participants who were treated with chemotherapy in second line therapy will be reported.
Percentage of Participants Treated With Other Therapies in Second Line Therapy	Day 1	Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.

Secondary Outcome Measures

Name	Time	Method
Eastern Cooperative Oncology Group (ECOG) Performance Status	Day 1	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).
Number of Participants with Comorbidities	Day 1	Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.
Blood Prostate Specific Antigen (PSA) levels	Day 1	Blood PSA levels will be reported.
Number of participants With Bone or Visceral Metastasis	Day 1	Participants with bone or visceral metastasis will be reported.
Assessment of Pain Related With Disease	Day 1	Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).
Percentage of Participants With Skeletal Related Events (SREs)	Day 1	SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.
Number of Participants who were used to define mCRPC Criteria	Day 1	Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.
Percentage of Participants Who Received Therapies After Second Line	Day 1	Participants who received therapies after second line will be reported.
Number of Participants With Gleason score	Day 1	Gleason scoring is used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a Baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).
Overall Survival	Day 1