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

Bayer86 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Radium-223-dichloride (Xofigo, BAY88-8223)DRUG

according to Summary of Product Characteristics

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Many Locations

Multiple Locations, Germany

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: Up to 60 months

Secondary Outcomes

Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients

Time frame: Up to 60 months

Estimation of the incidence of pathological fractures.

Time frame: Up to 60 months

Time to next tumor treatment(s) (TTNT)

Time frame: Up to 24 months

Incidence of treatment-emergent adverse events (TEAE)

Time frame: 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.

Time frame: Up to 60 months

Activities of daily living assessed according to the Katz-Index

Time frame: 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

Time frame: Up to 7 months

Estimation of the non-pathological fractures

Time frame: Up to 60 months

Data from ClinicalTrials.gov

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