Clinical trial · Observational
Second Primary Cancers in Patients With Castration Resistant Prostate Cancer
Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)
NCT02702908CI-TRIAL-00031273BOCARPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- mPC
- description
- Prostate cancer patients with bone metastases (mPC)
- label
- mCRPC
- description
- Patients with castration-resistant prostate cancer with bone metastases (mCRPC)
Primary outcomes (1)
- measure
- Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
- timeFrame
- Up to 10 years
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- Up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.