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

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ClinicalTrials.gov Identifier: NCT02450812
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Prostatic Neoplasms, Castration-Resistant Drug: Radium-223-dichloride (Xofigo, BAY88-8223)

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : May 28, 2015
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Radium-223-dichloride (Xofigo, BAY88-8223)
patients with mCRPC with symptomatic bone metastases
Drug: Radium-223-dichloride (Xofigo, BAY88-8223)
according to Summary of Product Characteristics




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 60 months ]

Secondary Outcome Measures :
  1. Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients [ Time Frame: Up to 60 months ]
  2. Estimation of the incidence of pathological fractures. [ Time Frame: Up to 60 months ]
  3. Time to next tumor treatment(s) (TTNT) [ Time Frame: Up to 24 months ]
  4. Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: Up to 30 days after last administration of Radium-223 ]
  5. Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire [ Time Frame: Up to 60 months ]
  6. Activities of daily living assessed according to the Katz-Index [ Time Frame: Up to 7 months ]
  7. 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 ]
  8. Estimation of the non-pathological fractures [ Time Frame: Up to 60 months ]
  9. Estimation of the bone associated events [ Time Frame: Up to 60 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450812


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
Germany
Many Locations Recruiting
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02450812     History of Changes
Other Study ID Numbers: 18043
XF 1503 ( Other Identifier: NIS )
EUPAS24796 ( Other Identifier: ENCePP )
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

Keywords provided by Bayer:
mCRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents