Registry of Treatment Outcomes of Symptomatic Metastasized Castration Resistant Prostate Cancer Treated With Radium-223 (ROTOR)

April 14, 2022 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

Radium-223 is the 5th treatment for metastasized castration resistant prostate cancer with a proven overall survival benefit. The improved survival of Radium-223 over placebo was demonstrated in the ALSYMPCA trial, which included a miscellaneous patient population both docetaxel pretreated and non-pretreated. This registry aims to describe non-study patients treated with Radium-223 and prospectively evaluate treatment outcomes of patients with and without docetaxel pretreatment. Analgesic use and patient reported pain scores, efficacy of the subsequent therapy and overall survival will be evaluated. Moreover, clinical and explorative serum and blood biomarkers of Radium-223 efficacy will be explored.

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

Every year approximately 12,000 men are diagnosed with prostate cancer in the Netherlands and approximately 2,400 die of this disease. When prostate cancer is limited to the prostate, patients can be operated or radiated with a curative intention, however, metastasized disease is incurable. Initially, prostate cancer responds to testosterone at castration level and treatment with androgen receptor signaling inhibitors. However, after an average of 24 months, prostate cancer will reach a castration resistant stage (mCRPC), which is associated with high morbidity and mortality. Since the introduction of Docetaxel in 2004, multiple treatments for mCRPC have become available. All these treatments have a proven beneficial effect on quality of life and all expand life expectancy. An important clinical problem is that approximately 50% of older patients are not able or not willing to receive docetaxel treatment. These patients are also not eligible for treatments of docetaxel refractory disease. Therefore, there is a need for effective treatments with little site effects.

In the phase 3, ALSYMPCA study 921 patients were randomized between Rad-223 (Xofigo®) and placebo in a 2:1 distribution1. Patients with symptomatic bone metastases, limited lymph node involvement, adequate bone marrow, kidney and liver functions were included in this trial. Patients were previously treated with docetaxel or could not receive docetaxel, declined docetaxel or docetaxel was not available. At a planned interim analysis after 538 deaths, the primary end point overall survival (OS) was 14.9 months in the Radium-223 treated arm and 11.3 months in the placebo arm (HR 0.70; 95% CI 0.58-0.83). All secondary end points were at the favor of Radium-223 treated patients, including time to first skeletal related event, quality of life and various biochemical end points. However, patient reported pain scores were not collected in the trial. Radium-223 treatment was well tolerated, with the most prominent side effects (all grades) thrombocytopenia 12 and 6%, neutropenia 5 and 1% and diarrhea 25 and 15% in the Radium-223 and placebo arm, respectively.

A post-hoc analysis showed an equal efficacy of Radium-223 treatment in docetaxel pre-treated patients as in docetaxel naïve patients.

In this registry the investigators aim to evaluate the efficacy of Radium-223 treatment and first subsequent therapy in a non-study population. Various parameters will be collected, including changes in patient reported pain score. Moreover, changes in serum and blood levels of biomarkers of bone metabolism and levels of blood osteoclast precursors in Radium-223 treated patients will be evaluated for their potential to predict 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.
300

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
      • 's Hertogenbosch, Netherlands
        • Jeroen Bosch Hospital
      • Alkmaar, Netherlands
        • Noordwest Ziekenhuisgroep
      • Almelo, Netherlands
        • Zorggroep Twente
      • Amsterdam, Netherlands, 1066CX
        • The Netherlands Cancer Intitute
      • Arnhem, Netherlands
        • Rijnstate
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Hospital
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Gouda, Netherlands
        • Groene Hart ziekenhuis
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Heerlen, Netherlands, 6401 CX
        • Atrium Medisch Centrum Parkstad
      • Hoofddorp, Netherlands
        • Spaarne Gasthuis
      • Nieuwegein, Netherlands
        • Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3045 PM
        • Franciscus Gasthuis-Vlietland
      • The Hague, Netherlands
        • Haga ziekenhuis
      • The Hague, Netherlands
        • MC Haaglanden
      • Utrecht, Netherlands
        • Universitair Medisch Centrum Utrecht
      • Zwolle, Netherlands
        • Isala Klinieken
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3818 ES
        • Meander Medical Center

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

Patients with metastasized castration resistant prostate cancer (mCRPC), who have bone metastases and no visceral metastases and receive Radium-223 according to the physician's discretion

Description

Inclusion Criteria:

  • At the physicians discretion

Exclusion Criteria:

  • At the physicians discretion
  • Radium-223 treatment in combination with another life-prolonging agent

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

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
Reported analgesic use and pain outcome
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 reported analgesic use and pain outcome, assessed by BPI-S, FACT-P and questionnaire about analgesic use.
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
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)
Efficacy on clinical parameters of treatment with Radium-223
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)
Efficacy of subsequent treatment on clinical parameters
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate the subsequent treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS) But also by patient records (recors of bonescans, CT scans, blood measurements, out-patient clinic visits).
through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Symptomatic Skeletal Events
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)
Evaluate the efficacy of Radium-223 by patient records
Time Frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Records of bonescans, CT scans, blood measurements, this will all be combined in one reported value; Progressve 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)

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.
January 17, 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 1, 2015

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 1, 2018

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 15, 2022

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 14, 2022

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.
July 1, 2017

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.
  • m14ROT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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