Clinical trial NCT02450812: Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: mCRPC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients
timeFrame: Up to 60 months
measure: Estimation of the incidence of pathological fractures.
timeFrame: Up to 60 months
measure: Time to next tumor treatment(s) (TTNT)
timeFrame: Up to 24 months
measure: Incidence of treatment-emergent adverse events (TEAE)
timeFrame: Up to 30 days after last administration of Radium-223
measure: Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire
timeFrame: Up to 60 months
measure: Activities of daily living assessed according to the Katz-Index
timeFrame: Up to 7 months
measure: Body function assessed in dimensions of "mobility", "self-care" and "domestic life" using the Medical Oncology Status in Europe Survey (MOSES) questionnaire
timeFrame: Up to 7 months
measure: Estimation of the non-pathological fractures
timeFrame: Up to 60 months
measure: Estimation of the bone associated events
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: