Onderzoek naar kwaliteit van leven en zorggebruik bij gevorderde prostaat kanker

Background of the study:
The annual incidence of castration-resistant prostate cancer (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. Cancer has a great impact on health related quality of life (HRQOL). Fortunately, several new treatments for CRPC have been registered. These treatments have a palliative nature, comparable survival benefits and considerable costs. Especially when survival benefits are comparable, patient reported outcomes are essential to optimize patient selection for treatment in the general medical oncology practice. Moreover, patient reported outcomes are essential for economic evaluations. This study will provide knowledge of HRQOL outcomes and indirect costs in the daily practice of CRPC treatment. These outcomes will help patients and clinicians in clinical decision making, to determine optimal treatment strategies and guide future development of guidelines, from both a clinical and economical perspective.

Objective of the study: The objectives are to determine generic, cancer-generic and prostate cancer-specific HRQOL and costs outside the hospital in CRPC patients during treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone and enzalutamide) in daily practice.

Study design: PRO-CAPRI is a prospective, observational, multi-center, cohort side study of the CAstration-resistant Prostate cancer RegIstry (CAPRI), an observational study in the Netherlands (NL3440). In September 2012, the observational CAPRI registry has been started. Clinical and economical outcomes are registered from 3600 CRPC patients, retrospectively included since 01-01-2010 in 20 hospitals from the Netherlands. The CAPRI and PRO-CAPRI outcomes will be combined for analysis.

Study population: A sample of the CAPRI population (CRPC patients). In 10 CAPRI hospitals, all CRPC patients will be identified and checked for eligibility. Newly diagnosed CRPC patients and patients starting a post-docetaxel treatment line are eligible. Informed consent is an inclusion criterium, and patients must be able to complete the questionnaires. A total of 200 patients will be included, and followed over time.

Primary study parameters/outcome of the study:
to determine the HRQOL at baseline and changes over time during CRPC treatment a. generic HRQOL by EQ VAS score and EQ-5D index value b. cancer specific HRQOL by EORTC QLQ-C30 score c. prostate cancer specific HRQOL by EORTC QLQ-PR25 score

Secundary study parameters/outcome of the study (if applicable): to determine a. indirect non-medical costs during CRPC treatment (productivity losses due to absenteeism) b. direct medical costs outside the hospital during CRPC treatment (medical resource use outside the hospital and informal care), and c. self-reported pain by BPI-SF pain severity and interference

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): Since the only intervention is a self-administered questionnaire, risks are negligible. The questionnaires take approximately 30 minutes to complete. Every three months the questionnaires will be repeated.

The annual incidence of castration-resistant prostate cancer (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. Cancer has a great impact on
health related quality of life (HRQOL). Fortunately, several new treatments for CRPC have been registered. These treatments have a palliative nature, comparable survival benefits and considerable costs. Especially when survival benefits are comparable, patient reported outcomes are essential to optimize patient selection for treatment in the general medical oncology practice. Moreover, patient reported outcomes are essential for economic evaluations. This study will provide knowledge of HRQOL outcomes and indirect costs in the daily practice of CRPC treatment. These outcomes will help patients and clinicians in clinical decision making, to determine optimal treatment strategies and guide future development of guidelines, from both a clinical and economical perspective.

t=0,3,6,9,12,15,18,21,24 months

Repeated HRQOL and cost assessment by questionnaires (EQ-5D, QLQ-C30, QLQ-PR25, BPI-SF and a selection of iMTA cost questionnaires every three months, starting at baseline.