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

Prostatic Neoplasms, Castration-Resistant Clinical Trial

— URANIS  

Official title:

URANIS -Data Collection in Urological Centers During Treatment With Ra-223 Dichloride (Xofigo) Within the Framework of a Non-interventional Study Assessing Overall Survival (OS) and Effectiveness Predictors of Ra-223 Dichloride Treated mCRPC Patients in a Real Life Setting in Germany.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450812
• Other study ID #: 18043
• Secondary ID: XF 1503EUPAS2479
• Status: Completed
• Start date: May 28, 2015
• Est. completion date: September 17, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 17, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Radium-223-dichloride (Xofigo, BAY88-8223)
according to Summary of Product Characteristics

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		Up to 60 months
Secondary	Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients		Up to 60 months
Secondary	Estimation of the incidence of pathological fractures.		Up to 60 months
Secondary	Time to next tumor treatment(s) (TTNT)		Up to 24 months
Secondary	Incidence of treatment-emergent adverse events (TEAE)		Up to 30 days after last administration of Radium-223
Secondary	Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire	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.	Up to 60 months
Secondary	Activities of daily living assessed according to the Katz-Index		Up to 7 months
Secondary	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
Secondary	Estimation of the non-pathological fractures		Up to 60 months
Secondary	Estimation of the bone associated events		Up to 60 months

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