Trial Condition(s):

Prostatic Neoplasms

Second primary cancers in patients with castration resistant prostate cancer (BOCARP)

Bayer Identifier:

18044

ClinicalTrials.gov Identifier:

NCT02702908

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride.

Inclusion Criteria
- Members of the mPC cohort will have to fulfill all of the following criteria:
 -- Valid information on sex, age and the region of residence
 -- A period of at least 12 months of continuous insurance preceding cohort entry
 -- Diagnosis of PC (ICD-10 Code C61) in the study period (01-Jan-2004 to 31-Dec-2011)
 -- Diagnosis of bone metastases (ICD-10 Code C79.5) in the enrolment period (01-Jan-2005 to 31-Dec-2011)
 -- In addition to the criteria of the mPC cohort, members of the mCRPC will additionally have to fulfill: 
 -- One of the following in the enrolment period and before or at the same time with bone metastases
 --- Discontinuation of the initial chemical castration, change of the agent or modality of the Androgen deprivation therapy (ADT), or start of treatment for advanced Prostate cancer (PC) after the primary ADT.
 --- Surgical castration and initiation of ADT treatment
--- Treatment with medication specific to mCRPC.
Exclusion Criteria
- Patients will be excluded from the mPC and from the mCRPC populations if they meet one of the following criteria:
 -- First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
 -- Use of any radiopharmaceuticals for bone metastases (e.g., samarium, strontium, rhenium, radium)

Trial Summary

Enrollment Goal
6442
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 

Trial Design