Prostatic Neoplasms, Castration-ResistantNavigantNCT02899104
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in United States.
Trial summary
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC. 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?
- Xofigo (Radium-223 dichloride, BAY88-8223)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 31 Mar 2019
- 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: mCRPC patients treated with Xofigo from 10 centers in the US
Who may be able to join
- Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
- Patients were at least 18 years of age as of the first diagnosis for mCRPC.
- Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
- First injection of Radium-223 must have started between periods
- 1-January-2014 to 30-June-2014 or 15-November-2014 to present.
- Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.
Who cannot join
- Patients who received Radium-223 as part in an interventional clinical trial
- Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
Read the detailed description
This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
- Being tested
- Xofigo (Radium-223 dichloride, BAY88-8223)
- 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.
Xofigo (Radium-223 dichloride, BAY88-8223)Drug
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 dichloride | Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223. Receives: Drug: Xofigo (Radium-223 dichloride, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining factors that drive physician decision for treatment selection.
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.
Measured: Up to 9 months
Secondary outcomes (23)
Most common treatment sequences
Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
Measured: Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
Measured: Up to 9 months
Mean Xofigo dose
Mean dose of each treatment received in the respective sequence
Measured: Up to 9 months
Duration of Xofigo treatment
Mean number of treatment cycles
Measured: Up to 9 months
Overall survival (OS)
Collect outcomes for patients following treatment for mCRPC including changes in overall survival
Measured: Up to 9 months
Time to radiographic progression
Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression
Measured: Up to 9 months
Time to PSA (Prostate specific antigen) progression
Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
Measured: Up to 9 months
Most common SRE (Skeletal Related Event)
The SRE occurring in the highest number of participants will be described.
Measured: Up to 9 months
Most common clinical intervention
Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
Measured: Up to 9 months
Time to first SSE(Symptomatic Skeletal Events)
Time to first SSE outcome will be analysed using the Kaplan Meier method
Measured: Up to 9 months
Reasons for discontinuation
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.
Measured: Up to 9 months
Change in laboratory values from baseline
for hemoglobin, platelets, neutrophils
Measured: Up to 9 months
Radiological progression free survival (rPFS)
change in laboratory values from baseline for radiological progression free survival (rPFS)
Measured: Up to 9 months
Time to alkaline phosphatase (ALP) progression
change in laboratory values from baseline for ALP
Measured: Up to 9 months
Time to visceral metastasis
time from baseline to the appearance of visceral metastasis
Measured: Up to 9 months
Time to onset of first subsequent treatment
or start of any other treatment for mCRPC
Measured: Up to 9 months
Pain
Based on chart reported pain
Measured: Up to 9 months
Most common symptoms
The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia
Measured: Up to 9 months
Type of physician
Define type of physicians that treat of mCRPC
Measured: Up to 9 months
Change in PSA from baseline to 12 weeks, and baseline to discontinuation
Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Measured: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Resource utilization
Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
Measured: Up to 9 months
Change in ALP from baseline to 12 weeks, and baseline to discontinuation
Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Measured: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Change in LDH from baseline to 12 weeks, and baseline to discontinuation
Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Measured: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start15 Jun 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 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
- NCT02899104
- Sponsor's protocol ID
- 18919
- Acronym
- Navigant
- Status last verified
- Mar 2020
- First submitted
- 19 Jul 2016
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
- ClinicalTrials.gov ID
- NCT02899104
- Acronym / sponsor ID
- Navigant / 18919
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 14 Sep 2016 (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.
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
Detailed description
This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride | – | Drug: Xofigo (Radium-223 dichloride, BAY88-8223)Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mCRPC patients treated with Xofigo from 10 centers in the US
Key inclusion criteria (6 listed)
- Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
- Patients were at least 18 years of age as of the first diagnosis for mCRPC.
- Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
- First injection of Radium-223 must have started between periods
- 1-January-2014 to 30-June-2014 or 15-November-2014 to present.
Key exclusion criteria (2 listed)
- Patients who received Radium-223 as part in an interventional clinical trial
- Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
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 |
|---|---|---|
| Xofigo (Radium-223 dichloride, BAY88-8223)Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. | Drug | Radium-223 dichloride |
Primary outcome
Determining factors that drive physician decision for treatment selection.
Time frame: Up to 9 months
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.
23 secondary outcomes
Most common treatment sequences
Time frame: Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
Time frame: Up to 9 months
Mean Xofigo dose
Time frame: Up to 9 months
Duration of Xofigo treatment
Time frame: Up to 9 months
Overall survival (OS)
Time frame: Up to 9 months
Time to radiographic progression
Time frame: Up to 9 months
Time to PSA (Prostate specific antigen) progression
Time frame: Up to 9 months
Most common SRE (Skeletal Related Event)
Time frame: Up to 9 months
Most common clinical intervention
Time frame: Up to 9 months
Time to first SSE(Symptomatic Skeletal Events)
Time frame: Up to 9 months
Reasons for discontinuation
Time frame: Up to 9 months
Change in laboratory values from baseline
Time frame: Up to 9 months
Radiological progression free survival (rPFS)
Time frame: Up to 9 months
Time to alkaline phosphatase (ALP) progression
Time frame: Up to 9 months
Time to visceral metastasis
Time frame: Up to 9 months
Time to onset of first subsequent treatment
Time frame: Up to 9 months
Pain
Time frame: Up to 9 months
Most common symptoms
Time frame: Up to 9 months
Type of physician
Time frame: Up to 9 months
Change in PSA from baseline to 12 weeks, and baseline to discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Resource utilization
Time frame: Up to 9 months
Change in ALP from baseline to 12 weeks, and baseline to discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Change in LDH from baseline to 12 weeks, and baseline to discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
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 31 Mar 2020.
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Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
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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 United States.
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 6 inclusion and 2 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 31 Mar 2020. 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 United States. 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?
Determining factors that drive physician decision for treatment selection. (time frame: Up to 9 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 31 Mar 2020.