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 Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)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

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:
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.
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).

Trial summary

Enrollment Goal

15953

Trial Dates

November 2016 - March 2017

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
Time Frame:
Up to 15 years
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
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Safety Issue:
No
Overall survival
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Safety Issue:
No
Pathologic fracture
ICD-10 codes: M49.5, M84.4, M90.7
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Safety Issue:
No
Spinal cord compression
ICD-10 codes: M43.9, M48.5, G95.2, G95.8
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Safety Issue:
No
Surgery to bone
Based on the Nordic Medico-Statistical Committee (NOMESCO) classification of surgical procedure codes (NCSP codes)
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Safety Issue:
No
Radiation to bone
Based on NCSP codes
Time Frame:
Up to 15 years for mPC patients and up to 7 years for mCRPC patients
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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