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Completed

NCT Number: NCT02230059

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Brasília, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Percentage of Participants Treated With Chemotherapy in First Line Therapy

    Time frame: Day 1

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

  2. Percentage of Participants Treated With Other Therapies in First Line Therapy

    Time frame: 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.

  3. Percentage of Participants Treated With Chemotherapy in Second Line Therapy

    Time frame: Day 1

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

  4. Percentage of Participants Treated With Other Therapies in Second Line Therapy

    Time frame: 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 outcomes

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: 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).

  2. Number of Participants with Comorbidities

    Time frame: Day 1

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

  3. Blood Prostate Specific Antigen (PSA) levels

    Time frame: Day 1

    Blood PSA levels will be reported.

  4. Number of participants With Bone or Visceral Metastasis

    Time frame: Day 1

    Participants with bone or visceral metastasis will be reported.

  5. Assessment of Pain Related With Disease

    Time frame: Day 1

    Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).

  6. Number of Participants With Gleason score

    Time frame: 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).

  7. Percentage of Participants With Skeletal Related Events (SREs)

    Time frame: Day 1

    SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.

  8. Number of Participants who were used to define mCRPC Criteria

    Time frame: Day 1

    Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.

  9. Percentage of Participants Who Received Therapies After Second Line

    Time frame: Day 1

    Participants who received therapies after second line will be reported.

  10. Overall Survival

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: REALIST-PRO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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