Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223 (ROTOR)

April 17, 2023 updated by: The Netherlands Cancer Institute

Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223

This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

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

Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers).

Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres).

All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.

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.
100

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

  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • The Netherlands Cancer Intitute
      • Rotterdam, Netherlands
        • Franciscus Gasthuis & Vlietland

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

Sampling Method

Probability Sample

Study Population

Men with prostate cancer and bone metastasis, which are to be treated with Radium-223.

Description

Inclusion Criteria:

  • At the physicians discretion
  • Age 18 year and older.
  • Written informed consent

Exclusion Criteria:

  • Previous treatment with Radium-223.
  • Participation in another Radium-223 study.

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

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
Efficacy of treatment on pain outcomes, as mentioned by the patient
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication).
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Efficacy of treatment by patient records
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)

But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits).

All of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission)
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)

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
Symptomatic Skeletal Event
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
To evaluate the efficacy of Radium-223 treatment in a nonstudy population by effects on Symptomatic Skeletal Event (SSE). Through patient records and questionnairs (FACT-P, BPI-S and use of painmedication).
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Clinical Parameters assessed by the WHO PS.
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS)
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate of the treatment after Radium-223 the treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Biomarkers
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)

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.
The Netherlands Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

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.
October 30, 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.
February 3, 2022

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.
February 3, 2023

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).
April 4, 2017

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.
July 17, 2017

First Posted (Actual)

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.
July 21, 2017

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.
April 18, 2023

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.
April 17, 2023

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.
April 1, 2023

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.
  • m15RTO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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