Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer ) (Navigant)

March 30, 2020 updated by: Bayer

Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223

Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Whippany, New Jersey, United States, 07981
        • Whippany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

mCRPC patients treated with Xofigo from 10 centers in the US

Description

Inclusion Criteria:

  • Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
  • Patients were at least 18 years of age as of the first diagnosis for mCRPC.
  • Patients must have received at least one intravenous injection of Radium-223 (Xofigo).

  • First injection of Radium-223 must have started between periods

    1-January-2014 to 30-June-2014 or 15-November-2014 to present.

  • Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.

Exclusion Criteria:

  • Patients who received Radium-223 as part in an interventional clinical trial
  • Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Radium-223 dichloride
Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223.
Drug: Xofigo (Radium-223 dichloride, BAY88-8223)
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determining factors that drive physician decision for treatment selection.
Time Frame: Up to 9 months
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.
Up to 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Most common treatment sequences
Time Frame: Up to 9 months
Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
Time Frame: Up to 9 months
Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
Up to 9 months
Mean Xofigo dose
Time Frame: Up to 9 months
Mean dose of each treatment received in the respective sequence
Up to 9 months
Duration of Xofigo treatment
Time Frame: Up to 9 months
Mean number of treatment cycles
Up to 9 months
Overall survival (OS)
Time Frame: Up to 9 months
Collect outcomes for patients following treatment for mCRPC including changes in overall survival
Up to 9 months
Time to radiographic progression
Time Frame: Up to 9 months
Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression
Up to 9 months
Time to PSA (Prostate specific antigen) progression
Time Frame: Up to 9 months
Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
Up to 9 months
Most common SRE (Skeletal Related Event)
Time Frame: Up to 9 months
The SRE occurring in the highest number of participants will be described.
Up to 9 months
Most common clinical intervention
Time Frame: Up to 9 months
Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
Up to 9 months
Time to first SSE(Symptomatic Skeletal Events)
Time Frame: Up to 9 months
Time to first SSE outcome will be analysed using the Kaplan Meier method
Up to 9 months
Reasons for discontinuation
Time Frame: Up to 9 months
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.
Up to 9 months
Change in laboratory values from baseline
Time Frame: Up to 9 months
for hemoglobin, platelets, neutrophils
Up to 9 months
Radiological progression free survival (rPFS)
Time Frame: Up to 9 months
change in laboratory values from baseline for radiological progression free survival (rPFS)
Up to 9 months
Time to alkaline phosphatase (ALP) progression
Time Frame: Up to 9 months
change in laboratory values from baseline for ALP
Up to 9 months
Time to visceral metastasis
Time Frame: Up to 9 months
time from baseline to the appearance of visceral metastasis
Up to 9 months
Time to onset of first subsequent treatment
Time Frame: Up to 9 months
or start of any other treatment for mCRPC
Up to 9 months
Pain
Time Frame: Up to 9 months
Based on chart reported pain
Up to 9 months
Most common symptoms
Time Frame: Up to 9 months
The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia
Up to 9 months
Type of physician
Time Frame: Up to 9 months
Define type of physicians that treat of mCRPC
Up to 9 months
Change in PSA from baseline to 12 weeks, and baseline to discontinuation
Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Resource utilization
Time Frame: Up to 9 months
Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
Up to 9 months
Change in ALP from baseline to 12 weeks, and baseline to discontinuation
Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Change in LDH from baseline to 12 weeks, and baseline to discontinuation
Time Frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Baseline and 12 weeks,Baseline and through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18919

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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