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Incidence of Second Primary Malignancies in Prostate Cancer Patients With Bone Metastases - an Observational Retrospective Cohort Study in Sweden (SMARCOS)

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ClinicalTrials.gov Identifier: NCT02963675
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)

Condition or disease
Prostatic Neoplasms

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
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Study Type : Observational
Actual Enrollment : 15953 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Second Primary MAlignancies in pRostate Cancer Patients With bOne Metastases - an Observational Retrospective Cohort Study in Sweden (SMARCOS)
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Group 1
Prostate cancer patients with bone metastases (mPC)
Group 2
Castration-resistant prostate cancer patients with bone metastases (mCRPC)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    Site-specific ICD-10 code groups from the range of all neoplasm codes C00 - D48

  2. Overall survival [ Time Frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients ]
  3. Pathologic fracture [ Time Frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients ]
    ICD-10 codes: M49.5, M84.4, M90.7

  4. Spinal cord compression [ Time Frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients ]
    ICD-10 codes: M43.9, M48.5, G95.2, G95.8

  5. Surgery to bone [ Time Frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients ]
    Based on the Nordic Medico-Statistical Committee (NOMESCO) classification of surgical procedure codes (NCSP codes)

  6. Radiation to bone [ Time Frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients ]
    Based on NCSP codes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
Criteria

Inclusion Criteria:mPC population; if the following criteria are fulfilled:

A.) PC diagnosis in 1.1.1998 - 31.12.2011 B.) Bone metastases diagnosis in 1.1.1999 - 31.12.2011 mCRPC population; if the following criteria are fulfilled:

  1. PC diagnosis in 1.1.1998 - 31.12.2011
  2. Bone metastases diagnosis in 1.1.2007 - 31.12.2011

  3. One of the following in 1.1.2006 - 31.12.2011 and before or at the same time with bone metastases diagnosis:

    1. Discontinuation of the initial chemical castration (androgen deprivation therapy, ADT), change of the agent or modality of ADT, or start of treatment for advanced PC after the primary ADT (including chemotherapy or mitoxantrone)
    2. Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards
    3. Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone).
    4. In a sensitivity analysis, also those who have had at least 6 months since the initiation of castration treatment before cohort entry date (bone metastases diagnosis) are included in the mCRPC population.

Exclusion Criteria:

  • 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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963675


Locations
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Sweden
Multiple Locations, Sweden
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02963675    
Other Study ID Numbers: 18105
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases