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

Completed

• Conditions: Prostate Cancer Metastatic; Bone Metastases

• Registration Number: NCT03223727
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study Start: 2015-10-30
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-21
• Primary Completion: 2022-02-03
• Study Completion: 2023-02-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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)
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
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).

Trial Locations

Locations (2)

The Netherlands Cancer Intitute; 🇳🇱 Amsterdam, Netherlands

Franciscus Gasthuis & Vlietland; 🇳🇱 Rotterdam, Netherlands