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

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.

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Drug: Radium-223-dichloride (Xofigo, BAY88-8223)

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of mCRPC patients with symptomatic bone metastases without known visceral metastases for whom the attending physician decided according to his/her medical practice to treat the patient with Radium-223 dichloride.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radium-223-dichloride (Xofigo, BAY88-8223); patients with mCRPC with symptomatic bone metastases	Drug: Radium-223-dichloride (Xofigo, BAY88-8223); according to Summary of Product Characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients		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
Incidence of treatment-emergent adverse events (TEAE)		Up to 30 days after last administration of Radium-223
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
Activities of daily living assessed according to the Katz-Index		Up to 7 months
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
Estimation of the non-pathological fractures		Up to 60 months
Estimation of the bone associated events		Up to 60 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2015
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): September 17, 2020

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: mCRPC
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 18043; XF 1503 (Other Identifier: NIS); EUPAS24796 (Other Identifier: ENCePP)