Prostatic Neoplasms, Castration-ResistantURANISNCT02450812
Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- Radium-223-dichloride (Xofigo, BAY88-8223)
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 28 May 2015to 17 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -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 locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Radium-223-dichloride (Xofigo, BAY88-8223)
- Keywords
- mCRPC
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223-dichloride (Xofigo, BAY88-8223)Drug
according to Summary of Product Characteristics
| Study group | Role | What they receive |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | patients with mCRPC with symptomatic bone metastases Receives: Drug: Radium-223-dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Up to 60 months
Secondary outcomes (9)
Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients
Measured: Up to 60 months
Estimation of the incidence of pathological fractures.
Measured: Up to 60 months
Time to next tumor treatment(s) (TTNT)
Measured: Up to 24 months
Incidence of treatment-emergent adverse events (TEAE)
Measured: Up to 30 days after last administration of Radium-223
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.
Measured: Up to 60 months
Activities of daily living assessed according to the Katz-Index
Measured: Up to 7 months
Body function assessed in dimensions of "mobility", "self-care" and "domestic life" using the Medical Oncology Status in Europe Survey (MOSES) questionnaire
Measured: Up to 7 months
Estimation of the non-pathological fractures
Measured: Up to 60 months
Estimation of the bone associated events
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study start28 May 2015
- Primary completion30 Jun 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450812
- Sponsor's protocol ID
- 18043
- Other IDs
- XF 1503, EUPAS24796
- Acronym
- URANIS
- Status last verified
- Oct 2021
- First submitted
- 19 May 2015
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02450812
- Acronym / sponsor ID
- URANIS / 18043
- Keywords
- mCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 May 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223) | – | Drug: Radium-223-dichloride (Xofigo, BAY88-8223)patients with mCRPC with symptomatic bone metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223-dichloride (Xofigo, BAY88-8223)according to Summary of Product Characteristics | Drug | Radium-223-dichloride (Xofigo, BAY88-8223) |
Primary outcome
Overall survival (OS)
Time frame: Up to 60 months
9 secondary outcomes
Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients
Time frame: Up to 60 months
Estimation of the incidence of pathological fractures.
Time frame: Up to 60 months
Time to next tumor treatment(s) (TTNT)
Time frame: Up to 24 months
Incidence of treatment-emergent adverse events (TEAE)
Time frame: Up to 30 days after last administration of Radium-223
Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire
Time frame: Up to 60 months
Activities of daily living assessed according to the Katz-Index
Time frame: Up to 7 months
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
Estimation of the non-pathological fractures
Time frame: Up to 60 months
Estimation of the bone associated events
Time frame: Up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.