Study Completed

Prostatic Neoplasms

Bayer Identifier:

18044

ClinicalTrials.gov Identifier:

NCT02702908

EudraCT Number:

Not Available

EU CT Number:

Not Available

Second primary cancers in patients with castration resistant prostate cancer

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

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

March 2016 - October 2017

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany

Primary Outcome

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

Secondary Outcome

Overall survival
Time Frame:
Up to 10 years
Safety Issue:
No

Trial design

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

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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.