check_circleStudy Completed

Prostatic Neoplasms

Bayer Identifier:

18105

ClinicalTrials.gov Identifier:

NCT02963675

EudraCT Number:

Not Available

EU CT Number:

Not Available
Incidence of second primary malignancies in prostate cancer patients with bone metastases – an observational retrospective cohort study in Sweden

Trial purpose

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 Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • 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:
    a.) 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)
    b.) Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards
    c.) Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone).
    d.) 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.
  • - 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 summary

Enrollment Goal
15953
Trial Dates
November 2016 - March 2017
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Sweden

Primary Outcome

  • Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
    date_rangeTime Frame:
    Up to 15 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Incidences of any site-specific second primary malignancies
    Site-specific ICD-10 code groups from the range of all neoplasm codes C00 – D48
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No
  • Pathologic fracture
    ICD-10 codes: M49.5, M84.4, M90.7
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No
  • Spinal cord compression
    ICD-10 codes: M43.9, M48.5, G95.2, G95.8
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No
  • Surgery to bone
    Based on the Nordic Medico-Statistical Committee (NOMESCO) classification of surgical procedure codes (NCSP codes)
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No
  • Radiation to bone
    Based on NCSP codes
    date_rangeTime Frame:
    Up to 15 years for mPC patients and up to 7 years for mCRPC patients
    enhanced_encryption
    Safety Issue:
    No

Trial design

Incidence of Second primary MAlignancies in pRostate Cancer patients with bOne metastases – an observational retrospective cohort study in Sweden (SMARCOS)
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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