|- candidate number||13252|
|- NTR Number||NTR3591|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-aug-2012|
|- Secondary IDs||2012/272 METC VUmc|
|- Public Title||Castration-resistant prostate cancer registry: An observational study in the Netherlands.|
Gevorderd, castratie-resistent prostaatkanker: Een observationele studie in Nederland.
|- Scientific Title||Castration-resistant prostate cancer registry: An observational study in the Netherlands.|
|- hypothesis||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 for CRPC have been registered (abiraterone, cabazitaxel) or are expected to be registered in the next two years (enzalutamide (MDV3100), 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 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.|
|- Healt Condition(s) or Problem(s) studied||Castration-resistant prostate cancer|
|- Inclusion criteria||1. Patients with castration-resistant prostate cancer, as 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 (<1,7 nmol/L). If no testosterone has been measured, treatment with surgical castration or medical castration (LHRH-agonists or -antagonists) has to be initiated prior to progression of prostate cancer;|
2. Patients diagnosed with CRPC after 01-01-2010.
|- Exclusion criteria||Lack of follow up (i.e. a second opinion without treatment (typically 1 or 2 outpatient clinic visits) or a single diagnostic procedure without treatment).|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2012|
|- planned closingdate||31-dec-2014|
|- Target number of participants||1500|
|- Primary outcome||To investigate treatment patterns and outcomes in CRPC in daily practice:|
1. Response and adverse events of systemic anti-cancer agents in CRPC (including Progression Free Survival (PFS) and Overall Survival (OS));
2. Resource use and costs of systemic anti-cancer agents in CRPC;
3. Patient reported outcomes (including health related quality of life) (in side study).
|- Secondary outcome||1. Supportive care use in daily practice (surgery, radiotherapy, radionucleides, bone resorption inhibitors, supportive drugs);|
2. Referral patterns and second opinion rate;
3. Reasons for treatment decisions (such as patient preference, comorbidity, age);
4. Variation in subgroups: Geographic regions, type of hospital, age groups, treatment groups.
|- Timepoints||Every participating hospital will be visited for data entry at least annually.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. H.M. Westgeest|
|- CONTACT for SCIENTIFIC QUERIES||Prof. PhD. C.A. Uyl-de Groot|
|- Sponsor/Initiator ||Erasmus University Rotterdam, Institute for Medical Technology Assessment|
(Source(s) of Monetary or Material Support)
|Janssen-Cilag BV en Sanofi-aventis Netherlands BV|
|- Brief summary||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.
To investigate treatment patterns, resource use and outcomes (response, adverse events) of CRPC treatment in daily practice.
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.
A retrospective observational, non-controlled, non-randomized registry.
20 hospitals will participate, balanced geographically and by type of hospital, with the aim to provide a representative selection of all CRPC patients in the Netherlands.
Data will be identified and abstracted from patient records in participating hospitals by trained employees of the institute of Medical Technology Assessment (iMTA). A web-based eCRF will 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).
|- Main changes (audit trail)|
|- RECORD||23-aug-2012 - 1-aug-2013|