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

Prostatic Neoplasms Clinical Trial

— REALIST-PRO  

Official title:

Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230059
• Other study ID #: CR100943
• Secondary ID: 212082PCR0001
• Status: Completed
• Phase: Phase 0
• First received: August 29, 2014
• Last updated: September 24, 2014
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• No Intervention
Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Treated With Chemotherapy in First Line Therapy	Participants treated with chemotherapy in first line therapy will be reported.	Day 1	No
Primary	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.	Day 1	No
Primary	Percentage of Participants Treated With Chemotherapy in Second Line Therapy	Participants who were treated with chemotherapy in second line therapy will be reported.	Day 1	No
Primary	Percentage of Participants Treated With Other Therapies in Second Line Therapy	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.	Day 1	No
Secondary	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).	Day 1	No
Secondary	Number of Participants with Comorbidities	Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.	Day 1	No
Secondary	Blood Prostate Specific Antigen (PSA) levels	Blood PSA levels will be reported.	Day 1	No
Secondary	Number of participants With Bone or Visceral Metastasis	Participants with bone or visceral metastasis will be reported.	Day 1	No
Secondary	Assessment of Pain Related With Disease	Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).	Day 1	No
Secondary	Number of Participants With Gleason score	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).	Day 1	No
Secondary	Percentage of Participants With Skeletal Related Events (SREs)	SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.	Day 1	No
Secondary	Number of Participants who were used to define mCRPC Criteria	Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.	Day 1	No
Secondary	Percentage of Participants Who Received Therapies After Second Line	Participants who received therapies after second line will be reported.	Day 1	No
Secondary	Overall Survival		Day 1	No

External Links

•   To learn how to participate in this trial please click here.