No registrations found.
ID
Source
Brief title
Health condition
castration-resistant prostate cancer
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
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).
Study objective
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.
Study design
Every participating hospital was visited for data entry at least annually.
Intervention
N/A
M.C.P. Kuppen
Amsterdam 1007 MB
The Netherlands
+31 (0)10 408 8555
kuppen@eshpm.eur.nl
M.C.P. Kuppen
Amsterdam 1007 MB
The Netherlands
+31 (0)10 408 8555
kuppen@eshpm.eur.nl
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 and before 01-01-2016.
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3440 |
| NTR-old | NTR3591 |
| Other | METC VUmc : 2012/272 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
H.M. Westgeest et al 2019. Second line cabazitaxel treatment in castration-resistant prostate cancer (CRPC) clinical trials compared to standard of care in CAPRI: an observational study in the Netherlands.Clinical Genitourinary Cancer(2019), doi: https://doi.org/10.1016/j.clgc.2019.05.018.