Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany

Completed

• Conditions: Prostatic Neoplasms, Castration-Resistant
• Interventions: Drug: Radium-223-dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT02450812
• Lead Sponsor: Bayer

Brief Summary

This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-21
• Study Start: 2015-05-28
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

• Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases
• Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

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Exclusion Criteria

-Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223-dichloride (Xofigo, BAY88-8223)	Radium-223-dichloride (Xofigo, BAY88-8223)	patients with mCRPC with symptomatic bone metastases

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 60 months

Secondary Outcome Measures

Name	Time	Method
Estimation of the non-pathological fractures	Up to 60 months
Estimation of the bone associated events	Up to 60 months
Estimation of the incidence of pathological fractures.	Up to 60 months
Time to next tumor treatment(s) (TTNT)	Up to 24 months
Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire	Up to 60 months	The FACT-P questionnaire version 4 is a 39-item questionnaire consisting of five domains; 'Physical well-being', 'Social/Family well-being', 'Emotional well-being', 'Functional well-being' and 'Additional concerns' (consisting of items relating specifically to prostate cancer and/or its treatment) and uses a 0-4 Likert-scale.
Body function assessed in dimensions of "mobility", "self-care" and "domestic life" using the Medical Oncology Status in Europe Survey (MOSES) questionnaire	Up to 7 months
Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients	Up to 60 months
Incidence of treatment-emergent adverse events (TEAE)	Up to 30 days after last administration of Radium-223
Activities of daily living assessed according to the Katz-Index	Up to 7 months

Trial Locations

Locations (1)

Many Locations; 🇩🇪 Multiple Locations, Germany