NCT02963675

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 Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,953

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

November 10, 2016

Last Update Submit

February 8, 2018

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.

    Up to 15 years

Secondary Outcomes (6)

  • Incidences of any site-specific second primary malignancies

    Up to 15 years for mPC patients and up to 7 years for mCRPC patients

  • Overall survival

    Up to 15 years for mPC patients and up to 7 years for mCRPC patients

  • Pathologic fracture

    Up to 15 years for mPC patients and up to 7 years for mCRPC patients

  • Spinal cord compression

    Up to 15 years for mPC patients and up to 7 years for mCRPC patients

  • Surgery to bone

    Up to 15 years for mPC patients and up to 7 years for mCRPC patients

  • +1 more secondary outcomes

Study Arms (2)

Group 1

Prostate cancer patients with bone metastases (mPC)

Group 2

Castration-resistant prostate cancer patients with bone metastases (mCRPC)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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:
  • PC diagnosis in 1.1.1998 - 31.12.2011
  • Bone metastases diagnosis in 1.1.2007 - 31.12.2011
  • One of the following in 1.1.2006 - 31.12.2011 and before or at the same time with bone metastases diagnosis:
  • 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)
  • Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards
  • Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone).
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

November 15, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

SE(1)