C61
Conditions
Interventions
Group 1: Retrospective analysis of cancer registry data of prostate cancer cases from the diagnosis years 2014-2024 (observational study)
Sponsors
IQVIA Commercial GmbH & Co. OHG
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. ICD-10 C61 2. Diagnosis years 2014-2024 3. Place of residence at diagnosis in the federal state of the requested registry (‘residence-related cases’) 4. At least one day survival / follow-up time 5. Minimum age of 18 years at diagnosis
Exclusion criteria
Exclusion criteria: 1. the case is known to the registry exclusively on the basis of a. a death certificate (DCO case) b. a pathology report c. a progress report d. a report to the tumour conference e. a combination of the aforementioned notification types 2. unknown vital status at the end of the follow-up period 3. patients who have experienced another cancer either up to 5 years before or within the time window up to 5 years after the diagnosis of prostate cancer (excluding non-melanotic skin tumours, ICD-10 C44)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival from date of diagnosis overall and stratified by stage, metastasis (yes/no) and, in the case of metastasis, by hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Description of socio-demographic and clinical characteristics 2) Description of the treatment patterns 3) Description of the longitudinal ‘lines of treatment’ (LoT) treatment sequences 4) Description of overall survival (OS) from the start of the 1st, 2nd, 3rd and 4th LoT 5) Description of progression-free survival (PFS) from the start of the 1st, 2nd, 3rd and 4th LoT 6) Description of the time to next treatment from start (TTNT) of the 1st, 2nd, 3rd and 4th LoTs 7) Description of the time to next treatment or death (TTNTD) from the start of the 1st, 2nd, 3rd and 4th LoTs 8) Description of the overall tumour response, i.e. the number of patients who achieved complete or partial remission or relapsed after treatment, and the number of patients with progression or recurrence at the site of the local/primary tumour, lymph nodes or distant metastases 9) Description of the response to surgery, i.e. the local residual status for the primary tumour and the overall residual status, for all prostate cancer patients overall, stratified by UICC stage 10) Description of the number and proportion of patients who experienced adverse events due to SACT and radiotherapy (events are recorded in the cancer registry if they occur within 90 days of the start of treatment), by type of adverse event and severity | — |
Countries
Germany
Contacts
Public ContactAnnika Waldmann
Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
Outcome results
None listed