ROTOR: Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
- 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)
- 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).
- 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).
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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At the physicians discretion
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Age 18 year and older.
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Written informed consent
Exclusion Criteria:
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Previous treatment with Radium-223.
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Participation in another Radium-223 study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Netherlands Cancer Intitute | Amsterdam | Netherlands | 1066CX | |
| 2 | Franciscus Gasthuis & Vlietland | Rotterdam | Netherlands |
Sponsors and Collaborators
- The Netherlands Cancer Institute
- Bayer
Investigators
- Principal Investigator: Andre Bergman, MD, PhD, The Netherlands Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- m15RTO