NCT03223597

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 15, 2022

Status Verified

July 1, 2017

Enrollment Period

15 days

First QC Date

April 4, 2017

Last Update Submit

April 14, 2022

Conditions

Prostate Cancer MetastaticBone Metastases

Keywords

Radium-223quality of lifePain

Outcome Measures

Primary Outcomes (1)

  • Reported analgesic use and pain outcome

    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 Outcomes (6)

  • Efficacy on clinical parameters of treatment with Radium-223

    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

    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

    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

    through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)

  • Symptomatic Skeletal Events

    through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)

  • +1 more secondary outcomes

Interventions

Radium-223 dichlorideDRUG

Registry of patients who receive Radium-223.

Also known as: Xofigo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • At the physicians discretion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Meander Medical Center

Amersfoort, Utrecht, 3818 ES, Netherlands

Location

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Zorggroep Twente

Almelo, Netherlands

Location

The Netherlands Cancer Intitute

Amsterdam, 1066CX, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf Hospital

Delft, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Atrium Medisch Centrum Parkstad

Heerlen, 6401 CX, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, Netherlands

Location

Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Franciscus Gasthuis-Vlietland

Rotterdam, 3045 PM, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

MC Haaglanden

The Hague, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Pain

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andre Bergman, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

July 21, 2017

Study Start

January 17, 2015

Primary Completion

February 1, 2015

Study Completion

March 1, 2018

Last Updated

April 15, 2022

Record last verified: 2017-07

Locations

NL(20)