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NCT Number: NCT02450812

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

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.

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Key information

Conditions

Prostatic Neoplasms, Castration-Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

according to Summary of Product Characteristics

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 60 months

Secondary outcomes

  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

    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.

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: URANIS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 21, 2015
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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