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

NCT03223727 | Completed

• 1 other identifier: m15RTO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer Metastatic; Bone Metastases

Keywords

Radium-223

Outcome Measures

Primary Outcomes (2)

• Efficacy of treatment on pain outcomes, as mentioned by the patient

  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

  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 Outcomes (5)

• Symptomatic Skeletal Event

  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.

  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)

• Biomarkers

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

Interventions

Blood tests DIAGNOSTIC_TEST

Blood tests for several bone markers (see summary)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Bayer: collaborator

Study Sites (2)

The Netherlands Cancer Intitute

Amsterdam, 1066CX, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Extra blood will be collected at baseline, 1st, 2nd, 3rd and 6th (or last) Radium-223 treatment. Changes in serum and blood levels of biomarkers of bone metabolism and levels of blood osteoclast precursors in Radium-223 treated patients will e evaluated for their potential to predict treatment outcome.

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Andre Bergman, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: July 21, 2017
• Study Start: October 30, 2015
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

NL (2)