Prostate CancerNCT02518698
Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
An observational study of Prostate Cancer, run by Bayer at 1 site in United States.
Trial summary
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments. Read more about this study
- Who is it for?
- Ages 55 to 88 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 1,163 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2015to 30 Sep 2017
- 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 55 to 88 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Castrated resistant prostate cancer patients with bone metastases
Who may be able to join
- First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
- Members age ≥ 55 to 89 years at index
- Medicare members with medical and pharmacy coverage; and
- Continuously enrolled during the pre- and post-index periods.
Who cannot join
- Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
- Members age ≥ 89 years of age at index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.
- Conditions
- Prostate Cancer
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Keywords
- Castrated resistant prostate cancer, Patients with bone metastases
- Medical subject headings
- Prostatic Neoplasms
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
Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / Treatment patterns | Patients with castrated resistant prostate cancer and 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 of mCRPC patients
mCRPC: Metastatic castrate-resistant prostate cancer
Measured: Up to 24 months
Number of skeletal related events (SREs) of the mCRPC patients
Measured: Up to 30 months
Type of skeletal related events (SREs) of the mCRPC patients
Measured: Up to 30 months
Number of patients with mCRPC with bone metastases
Measured: Up to 24 months
Type of treatments associated with mCRPC
Treatments could include chemotherapy or bone radiation
Measured: Up to 24 months
Duration for each treatment identified
Measured: Up to 30 months
Distribution of providers by treatment
Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)
Measured: Up to 30 months
Clinical and demographic characteristics of the mCRPC patients
Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use
Measured: Up to 12 months
Treatment patterns of mCRPC patients with bone metastases
Measured: Up to 30 months
Progression of the disease of mCRPC patients
Measured: Up to 12 months
Secondary outcomes (4)
All-cause healthcare resource utilization for mCRPC patients
Using all post-index medical and pharmacy claims, compute the count of physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services, and count of pharmacy claims
Measured: Up to 30 months
mCRPC-specific healthcare resource utilization for mCRPC patients
Healthcare resource utilization will be measured using all post-index medical and pharmacy claims to create counts for physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services and counts of pharmacy claims
Measured: Up to 30 months
All-cause healthcare costs for mCRPC patients
Healthcare costs will be determined using all post-index medical and pharmacy claims. The all-cause total (medical + pharmacy), medical and pharmacy costs will be computed. A family of general linear model analysis will be performed (medical, pharmacy, and total costs)
Measured: Up to 30 months
mCRPC-specific healthcare costs for mCRPC patients
Healthcare costs will be determined using all post-index medical and pharmacy claims where a diagnosis of mCRPC appears in any of the nine diagnosis positions. The mCRPC specific total (Medical + pharmacy), medical and pharmacy costs associated with these claims will be computed.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study start31 Aug 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Retrospective
- Enrolment
- 1,163 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
- NCT02518698
- Sponsor's protocol ID
- 18273
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT02518698
- Acronym / sponsor ID
- 18273
- Conditions
- Prostate Cancer
- Keywords
- Castrated resistant prostate cancer, Patients with bone metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,163 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 10 Aug 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.
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / Treatment patterns | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients with castrated resistant prostate cancer and bone metastases |
Who may qualify
- Ages
- 55 to 88 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Castrated resistant prostate cancer patients with bone metastases
Key inclusion criteria (4 listed)
- First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
- Members age ≥ 55 to 89 years at index
- Medicare members with medical and pharmacy coverage; and
- Continuously enrolled during the pre- and post-index periods.
Key exclusion criteria (2 listed)
- Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
- Members age ≥ 89 years of age at index date
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)Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223) | Drug | Cohort 1 / Treatment patterns |
Primary outcome
Overall survival of mCRPC patients
Time frame: Up to 24 months
mCRPC: Metastatic castrate-resistant prostate cancer
Number of skeletal related events (SREs) of the mCRPC patients
Time frame: Up to 30 months
Type of skeletal related events (SREs) of the mCRPC patients
Time frame: Up to 30 months
Number of patients with mCRPC with bone metastases
Time frame: Up to 24 months
Type of treatments associated with mCRPC
Time frame: Up to 24 months
Treatments could include chemotherapy or bone radiation
Duration for each treatment identified
Time frame: Up to 30 months
Distribution of providers by treatment
Time frame: Up to 30 months
Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)
Clinical and demographic characteristics of the mCRPC patients
Time frame: Up to 12 months
Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use
Treatment patterns of mCRPC patients with bone metastases
Time frame: Up to 30 months
Progression of the disease of mCRPC patients
Time frame: Up to 12 months
4 secondary outcomes
All-cause healthcare resource utilization for mCRPC patients
Time frame: Up to 30 months
mCRPC-specific healthcare resource utilization for mCRPC patients
Time frame: Up to 30 months
All-cause healthcare costs for mCRPC patients
Time frame: Up to 30 months
mCRPC-specific healthcare costs for mCRPC patients
Time frame: Up to 30 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 18 Sep 2018.
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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 Prostate Cancer, 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 4 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 18 Sep 2018. 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?
Overall survival of mCRPC patients (time frame: Up to 24 months). The study lists 10 primary outcomes in all. 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 18 Sep 2018.