Trial Condition(s):
Prostatic Neoplasms, Castration-Resistant
Non-interventional study with Ra-223 dichloride assessing overall survival and effectiveness predictors for mCRPC patients in a real life setting in Germany (URANIS)
Bayer Identifier:
18043
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall survival (OS)Timeframe: Up to 60 months
Secondary Outcome
- Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patientsTimeframe: Up to 60 months
- Estimation of the incidence of pathological fractures.Timeframe: Up to 60 months
- Time to next tumor treatment(s) (TTNT)Timeframe: Up to 24 months
- Incidence of treatment-emergent adverse events (TEAE)Timeframe: 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) questionnaireThe 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.Timeframe: Up to 60 months
- Activities of daily living assessed according to the Katz-IndexTimeframe: 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) questionnaireTimeframe: Up to 7 months
- Estimation of the non-pathological fracturesTimeframe: Up to 60 months
- Estimation of the bone associated eventsTimeframe: Up to 60 months
Additional Information
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