check_circleStudy Completed
Prostatic Neoplasms, Castration-Resistant
Bayer Identifier:
18043
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Non-interventional study with Ra-223 dichloride assessing overall survival and effectiveness predictors for mCRPC patients in a real life setting in Germany
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.
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
86Trial Dates
May 2015 - September 2020Phase
N/ACould I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Germany |
Primary Outcome
- Overall survival (OS)date_rangeTime Frame:Up to 60 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patientsdate_rangeTime Frame:Up to 60 monthsenhanced_encryptionNoSafety Issue:
- Estimation of the incidence of pathological fractures.date_rangeTime Frame:Up to 60 monthsenhanced_encryptionNoSafety Issue:
- Time to next tumor treatment(s) (TTNT)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Incidence of treatment-emergent adverse events (TEAE)date_rangeTime Frame:Up to 30 days after last administration of Radium-223enhanced_encryptionYesSafety Issue:
- 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.date_rangeTime Frame:Up to 60 monthsenhanced_encryptionNoSafety Issue:
- Activities of daily living assessed according to the Katz-Indexdate_rangeTime Frame:Up to 7 monthsenhanced_encryptionNoSafety Issue:
- Body function assessed in dimensions of “mobility”, “self-care” and “domestic life” using the Medical Oncology Status in Europe Survey (MOSES) questionnairedate_rangeTime Frame:Up to 7 monthsenhanced_encryptionNoSafety Issue:
- Estimation of the non-pathological fracturesdate_rangeTime Frame:Up to 60 months
- Estimation of the bone associated eventsdate_rangeTime Frame:Up to 60 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A