Castration-resistant prostate cancer registry: An observational study in the Netherlands.
Gevorderd, castratie-resistent prostaatkanker: Een observationele studie in Nederland.

Rationale:
The annual incidence of CRPC in the Netherlands is estimated at 2868 patients. Recent developments in anti-cancer agents have proven to be of clinical benefit, at the expense of increased budgetary impact. However, little is known about the clinical effectiveness and cost-effectiveness in daily practice. These insights will contribute to improvement of quality of care in CRPC treatment.

Study Objectives:
To investigate treatment patterns, resource use and outcomes (response, adverse events) of CRPC treatment in daily practice.

Patient population:
3,600 patients, that is approximately 15% of all CRPC patients in the Netherlands, were included. The inclusion period was from 1-1-2010 to 31-12-2015. Data collection ended at 31-12-2017.

Study design:
A retrospective observational, non-controlled, non-randomized registry.

Study centers:
20 hospitals participated, balanced geographically and by type of hospital, with the aim to provide a representative selection of all CRPC patients in the Netherlands.

Methodology:
Data were identified and abstracted from patient records in participating hospitals by trained employees of the institute of Medical Technology Assessment (iMTA). A web-based eCRF was be used for data collection.

Plans for data analysis:
Including, but not limited to: Pre-planned interim analyses; Clinical effectiveness in daily practice (PFS, OS); Serious adverse drug reaction rate; Resource use description;
Subgroup analysis (age groups, treatment strategy, geographic regions); Cost-effectiveness analysis (economic decision model).

The annual incidence of castration-resistant prostate cander (CRPC) in the Netherlands is estimated at 2868 patients. After development of CRPC, survival with best supportive care is not expected to exceed 12 months. Fortunately, several new treatments (cabazitaxel, abiraterone acetate plus prednisone, enzalutamide and radium-223) for CRPC have been registered. Since the new drugs have different mode of action and can be given in sequence, survival is extended to over 24 months for patients who have access to these treatments. Little is known about treatment patterns (including differences of outcomes between regions and changes in patterns over time), the factors that influence choice of treatment, patient reported outcomes and clinical effectiveness as well as cost effectiveness in daily practice.

Every participating hospital was visited for data entry at least annually.

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