Bone Metastases, Prostate Cancer Metastatic
Conditions
Keywords
Radium-223
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.
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.
Interventions
DIAGNOSTIC_TESTBlood tests
Blood tests for several bone markers (see summary)
Sponsors
Bayer
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment on pain outcomes, as mentioned by the patient | 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). |
| Efficacy of treatment by patient records | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS) |
| Biomarkers | 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 |
| 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) | 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). |
| 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) | Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events). |
| Symptomatic Skeletal Event | 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). |
Countries
Netherlands
Outcome results
None listed