check_circleStudy Completed

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

18043

ClinicalTrials.gov Identifier:

NCT02450812

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • -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


  • -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
86
Trial Dates
May 2015 - September 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    No
  • Estimation of the incidence of pathological fractures.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to next tumor treatment(s) (TTNT)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of treatment-emergent adverse events (TEAE)
    date_rangeTime Frame:
    Up to 30 days after last administration of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    No
  • Activities of daily living assessed according to the Katz-Index
    date_rangeTime Frame:
    Up to 7 months
    enhanced_encryption
    Safety Issue:
    No
  • Body function assessed in dimensions of “mobility”, “self-care” and “domestic life” using the Medical Oncology Status in Europe Survey (MOSES) questionnaire
    date_rangeTime Frame:
    Up to 7 months
    enhanced_encryption
    Safety Issue:
    No
  • Estimation of the non-pathological fractures
    date_rangeTime Frame:
    Up to 60 months
  • Estimation of the bone associated events
    date_rangeTime Frame:
    Up to 60 months

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
N/A

Additional Information

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