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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report mostly incidence and mortality data, only in selected countries or regions, and their content is frequently outdated.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

hgrosch1@its.jnj.com

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

Zusammenfassung der Ergebnisse