Capri, Pro-Capri

Title: Castration-resistant prostate cancer registry: An observational study in the Netherlands

Hypothesis: 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. Fortunately, several new treatments for CRPC have been registered (abiraterone, cabazitaxel) or are expected to be registered in the next two years (enzalutamide (MDV 3100), radium-223 (Alpharadin) and several drugs in phase 3 trials. 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 know 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.

Patient population: 1500 patients, that is approximately 15% of all CRPC patients in the Netherlands, will be included. The inclusion period will be from 1-1-2010 to 31-12-2013. Data collection will continue to at least 31-12-2014.

Update (Pro)Capri, 16-02-2016.

Trialregister for more information.

Title Patient Reported Outcomes in the Castration-resistant Prostate cancer RegIstry PRO-CAPRI

Hypothesis: 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.

Two populagtions are eligible for inclusion:
1. Patients newly diagnosed with CRPC. CRPC is defined by either the treating doctor/physician, or by the definition (prostate cancer that is progressing despite medical or surgical castration (i.e. castrate levels of testosterone (¡Ü 50 ng/dL or <1,7 nmol/L). If no testosterone has been measured, treatment with surgical castration or medical castration (LHRH-agonists or ¨Cantagonists) has to be initiated prior to progression of prostate cancer. Because anti-androgen withdrawal response may occur in patients treated with combined androgen blockade (medical or surgical castration plus continuous anti-androgen), progression must be evaluated after discontinuation of anti-androgens for 4 to 8 weeks. Progression is defined as either progression according to the treating doctor/physician; or PSA progression, that is two rising PSA values at a minimum of 1-week intervals with a minimum starting value of 2,0 ng/ml (= 2,0 ¦Ìg/L); or radiologic progression, that is the appearance of two or more new lesions on bone scintigraphy or measurable disease (local or nodal or visceral progression)).

2. Patients diagnosed with CRPC after 1-1-2010 and now start the first post-docetaxel treatment line.

The time window for inclusion is three months from the diagnosis of CRPC, and three weeks before and three weeks after the start of the first second-line treatment after docetaxel.

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