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

Bone Metastases Clinical Trial

— ROTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223727
• Other study ID #: m15RTO
• Status: Completed
• Start date: October 30, 2015
• Est. completion date: February 3, 2023

Study information

• Verified date: April 2023
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Blood tests
Blood tests for several bone markers (see summary)

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Intitute	Amsterdam
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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).	through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Secondary	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)	through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Secondary	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).	through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Secondary	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).	through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Secondary	Biomarkers	Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy	through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)