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Prostate Cancer MetastaticROTORNCT03223727

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

An observational study of Prostate Cancer Metastatic and Bone Metastases, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic, Bone Metastases
What is being tested?
Blood tests
How many people
100 participants
Where
2 sitesNetherlands
Study dates
30 Oct 2015to 3 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • The Netherlands Cancer Intitute

    Amsterdam, 1066CX

  • Franciscus Gasthuis & Vlietland

    Rotterdam

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Blood tests
Keywords
Radium-223

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood testsDiagnostic test

    Blood tests for several bone markers (see summary)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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)

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

Secondary outcomes (5)

  1. Symptomatic Skeletal Event

    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).

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

  2. Clinical Parameters assessed by the WHO PS.

    Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS)

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

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).

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

  4. Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    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).

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

  5. Biomarkers

    Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start30 Oct 2015
  3. Primary completion3 Feb 2022
  4. Study completion3 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223727
Sponsor's protocol ID
m15RTO
Acronym
ROTOR
Status last verified
Apr 2023
First submitted
4 Apr 2017
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer Metastatic and Bone Metastases, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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