A prospective registry of patients with a confirmed diagnosis of Adenocarcinoma of the prostate presenting with metastatic castrate-resistant prostate cancer
Titel der Studie/Acronym
A prospective registry of patients with a confirmed diagnosis of Adenocarcinoma of the prostate presenting with metastatic castrate-resistant prostate cancer
Zielsetzung/Fragestellung
Current national and regional prostate cancer patient registries, such as NORDCAN1 and EUROCARE2, report mostly incidence and mortality data, only in selected countries or regions, and their content is frequently outdated. Moreover, those registries are not sufficiently robust to enable comprehensive assessment of the effectiveness and safety of new treatment strategies, or to evaluate the impact on associated costs or on a patient´s quality of life.
Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness and safety profiles emerge outside of a clinical trial setting.
Data capture will occur across multidisciplinary functions in different countries to facilitate this understanding; this might provide a better understanding of the clinical characteristics and treatment strategy. Data outside the clinical setting are increasingly requested to support the continued recommendation and reimbursement of products by health authorities.
An observational registry in patients with mCRPC will allow for compilation of these important data. The resulting data analysis will facilityte clearer understanding of the optimal use of treatments for mCRPC, aid in evaluating the benefits of these treatments for patients in routine clinical practice, and provide for future health economic, pharmacoepidemiologic, and outcomes research.
1: NORDCAN wesite: http://www-dep.iarc.fr/nordcan/English/frame.asp. Accessed February 10, 2012
2: EUROpean CAncer Registry-based registry on survival and CARE of cancer patients. EUROCARE website: http://www.eurocare.it/. Accessed February 10, 2011
Indikation
- Prostatakarzinom, kastrationsresistent (CRPC)
Wirkstoff
- Abirateroneacetate (deutsch)
Handelsname(n)
Zytiga
Studie von Zulassungsbehörde gefordert oder von G-BA oder anderer Institution empfohlen
Nein
Studientyp
Rein exploratorische Untersuchung
Art der Studienzentren
Klinik, Praxis/niedergelassener Bereich
Untersuchung wird nur in D durchgeführt
Nein
Untersuchung wird auch in anderen Ländern mit gleichem Beobachtungsplan durchgeführt
Ja
primäre Zielgröße(n)
The objective of this prospective, observational registry is to document the characteristics and management of patients with mCRPC in routine clinical practice, independent of treatment used.
This will based on documentation and description of the following:
- Sequencing of treatment initiation, termination and duration;
- Realtive effectiveness of treatments;
- Definined medical resource utilization and quality-of-life parameters;
- Safety profile;
- Follow-up for survival
The registry is designed to generate data for informatiove purpose and as a resource for future analysis. Thus, the results will be presented desciptively and no formal hypotheses will be pre-specified.
Angaben zur Fallzahlbegründung
The Goal of the targetted 3.000-patient enrollment is to collect data on a large population that is representative of patients with mCRPC in the Europe/Middle East/Arfrica region. This cohort will be used to examine the population of mCRPC patients and current treatment patterns.
The registry is designed to generate data for informative purpose; eg. to be used in cost-effectiveness calculation. As a result, it is descriptive rather than comparative and no formal hypotheses are to be tested in this registry. The sample size is, therefore, mainly determined by pragmatic considerations.
Geplante Anzahl vorgesehener Studienzentren: für die Untersuchung insgesamt
200
Geplante Anzahl vorgesehener Studienzentren: Anzahl in Deutschland
24
Anzahl Studienzentren: für die Untersuchung insgesamt
179
Anzahl Studienzentren: Anzahl in Deutschland
25
Geplante Patientenzahl: für die Untersuchung insgesamt
3000
Geplante Patientenzahl: Anzahl in Deutschland
300
Patientenzahl: für die Untersuchung insgesamt
3000
Patientenzahl: Anzahl in Deutschland
394
Geplante Patientenzahl pro Praxis/Zentrum
15
Anpassungen der Dauer der Studie
60 Monate
Vergleichsgruppen: Therapie(n)/Prozedur(en)
Any treatment of mCRPC according with approved local labeling
Beginn der Studie
24.06.2013
Geplante Beobachtungsdauer je Patient
3 Jahre
Geplante Dauer der Studie
66 Monate
Studiennummer
212082PCR4001
Kontaktperson
Grosch, Dr. Hans-Wilhelm
Local Trial Manager
Janssen-Cilag GmbH
Johnson & Johnson Platz 1
41470 Neuss
Deutschland
Telefon: +49 2137955489
Telefax: +49 2137955488
Unternehmen
Janssen-Cilag GmbH
Johnson & Johnson Platz 1
41470 Neuss
Deutschland
Stand der Information
05.02.2020
Status der Studie
Studie bereits abgeschlossen