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

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ClinicalTrials.gov Identifier: NCT02230059
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Other: No Intervention

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.

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Study Type : Observational
Actual Enrollment : 382 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)
Study Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Metastatic Castration-resistant Prostate Cancer
Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
Other: No Intervention
Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230059


Locations
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Brazil
Brasilia, Brazil
Curitiba, Brazil
Distrito Federal, Brazil
Florianopolis, Brazil
Goiania, Brazil
Ijuí, Brazil
Jau, Brazil
Porto Alegre, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02230059     History of Changes
Other Study ID Numbers: CR100943
212082PCR0001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Janssen Research & Development, LLC:
Prostatic Neoplasms
observational Study
Metastatic castration-resistant prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases