Prostatic NeoplasmsNCT02788409
Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
An observational study of Prostatic Neoplasms, run by Bayer at 1 site in United States.
Trial summary
This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Not applicable for study
- How many people
- 2,234 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2016to 9 May 2018
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: The cohort will include men who are enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date, have a primary site code of prostate cancer in SEER data, have surgical castration or androgen deprivation therapy after prostate cancer diagnosis, have evidence that prostate cancer was resistant to the castration as indicated by starting a second-line systemic therapy, and have an cohort entry date of 01 January 2006 or later on which they are aged 65 years or older. All eligible subjects will be selected; there will be no sampling. (The probability of selecting each eligible patient is equal to 1)
Who may be able to join
- Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
- Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition [ICD-O-3] topography code C61.9) in SEER data
- Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
- Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
- Cohort entry date 01 January 2006 or later
- Age 65 years or older in the US on the cohort entry date
Who cannot join
- Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
- Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
- Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
- Any claim for treatment with Xofigo on or before the cohort entry date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.
Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.
Read the detailed description
Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.
To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.
- Conditions
- Prostatic Neoplasms
- Being tested
- Not applicable for study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable for studyOther
Provide external perspective on background second primary cancer incidence rates for REASSURE study.
| Study group | Role | What they receive |
|---|---|---|
| Medicare CRPC | Men in the US older than 65 years old having CRPC Receives: Other: Not applicable for study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of second primary malignancy
Measured: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Incidence rates of skeletal-related events
Measured: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Secondary outcomes (3)
Proportion with a history of bone metastasis at cohort entry
Measured: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Proportion who met the definition of castration based solely on Part D data
Measured: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Overall survival
Measured: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start15 May 2016
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- 2,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788409
- Sponsor's protocol ID
- 18673
- Status last verified
- May 2019
- First submitted
- 27 May 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
- ClinicalTrials.gov ID
- NCT02788409
- Acronym / sponsor ID
- 18673
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,234 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 15 May 2016 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 2 Jun 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.
This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.
Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.
Detailed description
Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.
To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicare CRPC | – | Other: Not applicable for studyMen in the US older than 65 years old having CRPC |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The cohort will include men who are enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date, have a primary site code of prostate cancer in SEER data, have surgical castration or androgen deprivation therapy after prostate cancer diagnosis, have evidence that prostate cancer was resistant to the castration as indicated by starting a second-line systemic therapy, and have an cohort entry date of 01 January 2006 or later on which they are aged 65 years or older. All eligible subjects will be selected; there will be no sampling. (The probability of selecting each eligible patient is equal to 1)
Key inclusion criteria (6 listed)
- Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
- Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition [ICD-O-3] topography code C61.9) in SEER data
- Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
- Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
- Cohort entry date 01 January 2006 or later
Key exclusion criteria (4 listed)
- Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
- Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
- Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
- Any claim for treatment with Xofigo on or before the cohort entry 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 |
|---|---|---|
| Not applicable for studyProvide external perspective on background second primary cancer incidence rates for REASSURE study. | Other | Medicare CRPC |
Primary outcome
Incidence rate of second primary malignancy
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Incidence rates of skeletal-related events
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
3 secondary outcomes
Proportion with a history of bone metastasis at cohort entry
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Proportion who met the definition of castration based solely on Part D data
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Overall survival
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
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 8 May 2019.
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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, 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 4 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 8 May 2019. 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?
Incidence rate of second primary malignancy (time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013). The study lists 2 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 8 May 2019.