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

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.

Study Overview

• Status: Completed
• Conditions: Bone Metastases; Prostate Cancer Metastatic
• Intervention / Treatment: Diagnostic test: Blood tests

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • The Netherlands Cancer Intitute
  • Rotterdam, Netherlands
    • Franciscus Gasthuis & Vlietland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2015
• Primary Completion (Actual): February 3, 2022
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Radium-223
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: m15RTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No