Prostatic NeoplasmsSMARCOSNCT02963675
Incidence of Second Primary Malignancies in Prostate Cancer Patients With Bone Metastases - an Observational Retrospective Cohort Study in Sweden
An observational study of Prostatic Neoplasms, run by Bayer at 1 site in Sweden.
Trial summary
This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 15,953 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2016to 31 Mar 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PC diagnosis in 1.1.1998 - 31.12.2013 and with bone metastases diagnosis or bone-directed treatments in 1.1.1998 - 31.12.2013 will be initially included into the large study population. From this initial population, the main analyses will concentrate on the following two populations: * Prostate cancer patients with bone metastases (mPC), and * Castration-resistant prostate cancer patients with bone metastases (mCRPC)
Who may be able to join
None listed.
Who cannot join
- First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
- Permanent residence not in Sweden or patient otherwise not contributing to the registers at least a year before the diagnosis of bone metastases (patient counted not contributing also if database existence less than a year before cohort entry), or
- Use of any radiopharmaceuticals for bone metastases (ATC code): Samarium (V10BX02), strontium (V10BX01), rhenium (V10BX03) or radium (V10XX03).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Second Primary MAlignancies in pRostate Cancer Patients With bOne Metastases - an Observational Retrospective Cohort Study in Sweden (SMARCOS)
This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)
Read the detailed description
Prostate cancer (PC) is the most common non-cutaneous malignancy in men. Once it becomes metastatic, it poses a serious threat to the patients' quality of life and survival. The most common site of metastases is the skeletal system: Among castration-resistant prostate cancer patients bone metastases are involved in over 90% of metastatic cases.
The development of new treatments has led to improved quality of life and prolonged lifetime among castration-resistant prostate cancer patients with metastases (mCRPC). A recent randomized clinical trial indicated significant improvement in survival and quality of life among patients with bone metastases treated with alpha emitter radium-223 as compared with placebo. To further evaluate the safety profile of Radium-223 in patients with castration resistant prostate cancer with bone metastases, Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (the REASSURE study), an international prospective observational single-arm cohort study was implemented as a post-marking requirement requested by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
In the case that new treatments improve the length and quality of life substantially, it can be challenging to obtain an appropriate comparison group in the post-authorization phase. This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival are of particular interest. Information from this study will serve as a historical reference for the REASSURE study
- Conditions
- Prostatic Neoplasms
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
external unexposed reference group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Prostate cancer patients with bone metastases (mPC) | |
| Group 2 | Castration-resistant prostate cancer patients with bone metastases (mCRPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Measured: Up to 15 years
Secondary outcomes (6)
Incidences of any site-specific second primary malignancies
Site-specific ICD-10 code groups from the range of all neoplasm codes C00 - D48
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Overall survival
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Pathologic fracture
ICD-10 codes: M49.5, M84.4, M90.7
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Spinal cord compression
ICD-10 codes: M43.9, M48.5, G95.2, G95.8
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Surgery to bone
Based on the Nordic Medico-Statistical Committee (NOMESCO) classification of surgical procedure codes (NCSP codes)
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Radiation to bone
Based on NCSP codes
Measured: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start15 Nov 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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
- 15,953 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
- NCT02963675
- Sponsor's protocol ID
- 18105
- Acronym
- SMARCOS
- Status last verified
- Feb 2018
- First submitted
- 10 Nov 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Second Primary MAlignancies in pRostate Cancer Patients With bOne Metastases - an Observational Retrospective Cohort Study in Sweden (SMARCOS)
- ClinicalTrials.gov ID
- NCT02963675
- Acronym / sponsor ID
- SMARCOS / 18105
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,953 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Nov 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 obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)
Detailed description
Prostate cancer (PC) is the most common non-cutaneous malignancy in men. Once it becomes metastatic, it poses a serious threat to the patients' quality of life and survival. The most common site of metastases is the skeletal system: Among castration-resistant prostate cancer patients bone metastases are involved in over 90% of metastatic cases.
The development of new treatments has led to improved quality of life and prolonged lifetime among castration-resistant prostate cancer patients with metastases (mCRPC). A recent randomized clinical trial indicated significant improvement in survival and quality of life among patients with bone metastases treated with alpha emitter radium-223 as compared with placebo. To further evaluate the safety profile of Radium-223 in patients with castration resistant prostate cancer with bone metastases, Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (the REASSURE study), an international prospective observational single-arm cohort study was implemented as a post-marking requirement requested by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
In the case that new treatments improve the length and quality of life substantially, it can be challenging to obtain an appropriate comparison group in the post-authorization phase. This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival are of particular interest. Information from this study will serve as a historical reference for the REASSURE study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Prostate cancer patients with bone metastases (mPC) |
| Group 2 | – | –Castration-resistant prostate cancer patients with bone metastases (mCRPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PC diagnosis in 1.1.1998 - 31.12.2013 and with bone metastases diagnosis or bone-directed treatments in 1.1.1998 - 31.12.2013 will be initially included into the large study population. From this initial population, the main analyses will concentrate on the following two populations: * Prostate cancer patients with bone metastases (mPC), and * Castration-resistant prostate cancer patients with bone metastases (mCRPC)
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
- Permanent residence not in Sweden or patient otherwise not contributing to the registers at least a year before the diagnosis of bone metastases (patient counted not contributing also if database existence less than a year before cohort entry), or
- Use of any radiopharmaceuticals for bone metastases (ATC code): Samarium (V10BX02), strontium (V10BX01), rhenium (V10BX03) or radium (V10XX03).
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 |
|---|---|---|
| external unexposed reference group | Other | Group 1, Group 2 |
Primary outcome
Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Time frame: Up to 15 years
6 secondary outcomes
Incidences of any site-specific second primary malignancies
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Overall survival
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Pathologic fracture
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Spinal cord compression
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Surgery to bone
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Radiation to bone
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
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 12 Feb 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 Prostatic Neoplasms, run by Bayer at 1 site in Sweden.
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 0 inclusion and 3 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 12 Feb 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 Sweden. 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?
Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. (time frame: Up to 15 years). 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 12 Feb 2018.