Prostatic Neoplasms, Castration-Resistant
Conditions
Keywords
mCRPC
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.
Interventions
according to Summary of Product Characteristics
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 60 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients | Up to 60 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 | — |
| Activities of daily living assessed according to the Katz-Index | Up to 7 months | — |
Countries
Germany
Outcome results
None listed