Skip to main content
OpenTrials
Completed

NCT Number: NCT03223727

Treatment Outcomes in a Non-study Population of Symptomatic 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Metastatic Bone Metastases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

The Netherlands Cancer Intitute, Amsterdam, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood tests

Diagnostic Test

Blood tests for several bone markers (see summary)

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. 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).

  2. 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)

  3. 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).

  4. 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).

  5. 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

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: ROTOR

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2017
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.