Clinical trial · Observational
Incidence of Second Primary Malignancies in Prostate Cancer Patients With Bone Metastases - an Observational Retrospective Cohort Study in Sweden
Incidence of Second Primary MAlignancies in pRostate Cancer Patients With bOne Metastases - an Observational Retrospective Cohort Study in Sweden (SMARCOS)
- 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 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 Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)
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
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Prostate cancer patients with bone metastases (mPC)
- label
- Group 2
- description
- Castration-resistant prostate cancer patients with bone metastases (mCRPC)
Primary outcomes (1)
- measure
- Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
- timeFrame
- Up to 15 years
Secondary outcomes (6)
- measure
- Incidences of any site-specific second primary malignancies
- timeFrame
- Up to 15 years for mPC patients and up to 7 years for mCRPC patients
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. 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) 2. Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards 3. Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone). 4. 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).
References
Publications (0)
Data not yet available