Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases (PARABO)

November 1, 2021 updated by: Bayer

PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers

This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.

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.

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.
363

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

  • Germany
      • Multiple Locations, Germany

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

The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.

Description

Inclusion Criteria:

  • Adult male patients diagnosed with CRPC with symptomatic bone metastases without known visceral metastases
  • Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

Exclusion Criteria:

  • Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo

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: Cohort
  • Time Perspectives: Prospective

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
Male patients with a diagnosis of CRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223 has been made by the attending physician according to his/her medical practice.
Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)
Dosage and treatment duration according to the decision of the treating physician

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
Pain response
Time Frame: Up to 6 months
Determined by the worst pain item on the Brief Pain Inventory - Short Form (BPI-SF) patient questionnaire. A clinically meaningful pain response is defined as an improvement of two points from the baseline BPI-SF worst pain score at any post-baseline assessment.
Up to 6 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
Change of pain over time
Time Frame: Up to 6 months from baseline
Determined by evaluating the worst pain item as well as the subscale scores for pain severity and pain interference as determined by patient responses on the BPI-SF questionnaire.
Up to 6 months from baseline
Change in bone pain related quality of life
Time Frame: Up to 6 months from baseline
As determined by patient responses on the bone pain specific Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain (FACT-BP) questionnaire
Up to 6 months from baseline
Pain control rate
Time Frame: Up to 6 months
As determined by the worst pain item on the BPI-SF patient questionnaire. Pain control is defined as no increase by two points from the baseline BPI-SF worst pain score.
Up to 6 months
Pain progression rate
Time Frame: Up to 6 months
As determined by the worst pain item on the BPI-SF patient questionnaire. Pain progression is defined as an increase by two points from the baseline BPI-SF worst pain score at any post baseline assessment.
Up to 6 months
Time to first pain progression
Time Frame: Up to 6 months
Defined as the time between the first injection of Radium-223 until an increase in the BPI-SF worst pain item by at least two points
Up to 6 months
Time to first opioid use
Time Frame: Up to 5.5 years
Up to 5.5 years
Summary description of covariates on pain response
Time Frame: Up to 6 months
The following covariates will be analyzed: opioid use, assessment of extent of bone metastases, location of bone metastases,level of alkaline phosphatase at baseline, PSA (Prostate Specific Antigen) level at baseline, WHO pain score at baseline, pretreatment with chemotherapy (yes/no), pretreatment with deep androgen ablation by treatment with abiraterone or enzalutamide (yes/no), extent of bone uptake in known lesions, BSI
Up to 6 months
Relation between bone uptake in known lesions and pain palliation
Time Frame: Up to 6 months
Only in patients with bone scan prior to start of treatment and a second scan during or within 6 weeks after end of Radium-223 treatment
Up to 6 months
Dosage of Radium-223
Time Frame: Up to 5 months
Up to 5 months
Number of injections of Radium-223
Time Frame: Up to 5 months
Up to 5 months
Course of blood count presented as percentage of patients below limit for further injections according to the local product information
Time Frame: Up to 5 months
Up to 5 months
Number of participants with Treatment-emergent Adverse Events (TEAE)
Time Frame: Up to 6 months
Up to 6 months
Time to next tumor treatment(s) (TTNT)
Time Frame: Up to 5.5 years
Defined as the time from the first application of Radium-223 until start of next mCRPC treatment including e.g. chemotherapy and/or hormonal treatment
Up to 5.5 years
Time to first symptomatic skeletal event (SSE)
Time Frame: Up to 5.5 years
Defined as the time between the first injection of Radium-223 until the occurrence of first SSE defined as the first use of external beam radiation therapy to relieve skeletal symptoms, new symptomatic pathological vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Up to 5.5 years
Overall survival
Time Frame: Up to 5.5 years
Defined as the time interval from the start of Radium-223 therapy to death, due to any cause. Patients alive at the end of the study will be censored at the last date known to be alive.
Up to 5.5 years
Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC)
Time Frame: Up to 6 months
Evaluated by comparing BSI values before and after Radium-223 treatment as well as by investigating the association of BSI with other outcome parameters like OS
Up to 6 months
Effect of concomitant drug treatment on pain, quality of life, and overall survival
Time Frame: Up to 5.5 years
Exploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)
Up to 5.5 years
Time from castration resistance to treatment with Radium-223
Time Frame: First treatment
Time from verified castration resistance to first injection of Radium-223
First treatment
Description of covariates on duration of therapy
Time Frame: Up to 6 months
Description of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.
Up to 6 months
Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections
Time Frame: Up to 6 months
(e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)
Up to 6 months
Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up
Time Frame: Up to 5.5 years
Up to 5.5 years

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.
March 19, 2015

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.
May 20, 2020

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.
July 15, 2020

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).
March 20, 2015

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.
March 20, 2015

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.
March 25, 2015

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.
November 2, 2021

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.
November 1, 2021

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.
October 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 17550
  • XF1412DE (Other Identifier: Company internal)

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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