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.
3 other identifiers
observational
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedStudy Start
First participant enrolled
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2020
CompletedNovember 2, 2021
October 1, 2021
5.1 years
May 19, 2015
November 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Up to 60 months
Secondary Outcomes (9)
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
Up to 60 months
- +4 more secondary outcomes
Study Arms (1)
Radium-223-dichloride (Xofigo, BAY88-8223)
patients with mCRPC with symptomatic bone metastases
Interventions
according to Summary of Product Characteristics
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Many Locations
Multiple Locations, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 21, 2015
Study Start
May 28, 2015
Primary Completion
June 30, 2020
Study Completion
September 17, 2020
Last Updated
November 2, 2021
Record last verified: 2021-10