A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

NCT ID: NCT02236637

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-14
• Study Completion Date: 2018-11-21

Brief Summary

The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. 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 profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

Detailed Description

This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases. Observational methodology will be used to capture data. The decision of patients to take part in the registry will not influence their medical care. Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice. Only data available from routine clinical practice will be collected. It is expected that approximately 3,000 patients will participate in this registry. To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment. The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site. The anticipated duration of patient enrollment is 2.5 years. The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled. The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry. Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice. Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment. This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance. During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mCRPC patients

Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate Patients with documented metastatic prostate cancer Patients with documented castration resistance Patients either: Initiating a new systemic mCRPC treatment; or considered to be in surveillance according to clinical practice Sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (ICF), per local regulations.

Exclusion Criteria

Any patient who is withdrawn from the registry for any reason may not re-enter the registry

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salzburg, , Austria

Vienna, , Austria

Aalst, , Belgium

Antwerp, , Belgium

Bonheiden, , Belgium

Brasschaat, , Belgium

Bruges, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Kortrijk, , Belgium

Liège, , Belgium

Ostend, , Belgium

Ottignies, , Belgium

Roeselare, , Belgium

Turnhout, , Belgium

Angers, , France

Avignon, , France

Béziers, , France

Brest, , France

Gap, , France

Hyères, , France

La Tronche, , France

Marseille, , France

Metz, , France

Montpellier, , France

Nancy, , France

Paris, , France

Périgueux, , France

Pierre-Bénite, , France

Pringy, , France

Reims, , France

Rennes, , France

Saint-Grégoire, , France

Saint-Mandé, , France

Saint-Quentin, , France

Toulouse, , France

Tours, , France

Augsburg, , Germany

Bad Saarow, , Germany

Bautzen, , Germany

Berlin, , Germany

Braunschweig, , Germany

Chemnitz, , Germany

Duisburg, , Germany

Erkrath, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Holzminden, , Germany

Jena, , Germany

Kiel, , Germany

Kirchheim, , Germany

Nürtingen, , Germany

Remscheid, , Germany

Reutlingen, , Germany

Rostock, , Germany

Schwerin, , Germany

Sindelfingen, , Germany

Tübingen, , Germany

Ulm, , Germany

Weiden, , Germany

Wilhelmshaven, , Germany

Würselen, , Germany

Beer Yaakov, , Israel

Beersheba, , Israel

Haifa, , Israel

Holon, , Israel

Tel Aviv, , Israel

Luxembourg, , Luxembourg

Niedercorn, , Luxembourg

Bydgoszcz, , Poland

Gdynia, , Poland

Krakow, , Poland

Lodz, , Poland

Opole, , Poland

Poznañ, , Poland

Warsaw, , Poland

Braga, , Portugal

Coimbra, , Portugal

Evora, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Setúbal, , Portugal

Moscow, , Russia

Obninsk, , Russia

Omsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Ufa, , Russia

Yekaterinburg, , Russia

Celje, , Slovenia

Ljubljana, , Slovenia

Slovenj Gradec, , Slovenia

A Coruña, , Spain

Asturias, , Spain

Barakaldo Vizcaya, , Spain

Barcelona, , Spain

Bilbao Vizcaya, , Spain

Girona, , Spain

Langreo, , Spain

Palma de Mallorca, , Spain

Pontevedra, , Spain

Sabadell, , Spain

Salamanca, , Spain

Santiago de Compostela, , Spain

Valladolid, , Spain

Zaragoza, , Spain

Borås, , Sweden

Gothenburg, , Sweden

Malmo, , Sweden

Örebro, , Sweden

Östersund, , Sweden

Stockholm, , Sweden

Umeå, , Sweden

Vaxjo, , Sweden

Västerås, , Sweden

Aarau, , Switzerland

Winterthur, , Switzerland

Ankara, , Turkey (Türkiye)

Edirne, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Kayseri, , Turkey (Türkiye)

Kocaeli, , Turkey (Türkiye)

Turkey, , Turkey (Türkiye)

Ashton-under-Lyne, , United Kingdom

Barnstaple, , United Kingdom

Blackburn, , United Kingdom

Bournemouth, , United Kingdom

Bradford, , United Kingdom

Brighton Sussex, , United Kingdom

Burton, , United Kingdom

Crewe, , United Kingdom

Huddersfield, , United Kingdom

Lancaster, , United Kingdom

Leeds Yorks, , United Kingdom

London, , United Kingdom

N/a N/a, , United Kingdom

Plymouth, , United Kingdom

Scunthorpe, , United Kingdom

Steeton, , United Kingdom

Stoke-on-Trent, , United Kingdom

Taunton, , United Kingdom

Torquay, , United Kingdom

Wakefield, , United Kingdom

Wigan, , United Kingdom

York, , United Kingdom

Countries

Austria; Belgium; France; Germany; Israel; Luxembourg; Poland; Portugal; Russia; Slovenia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettre S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.

Reference Type: DERIVED

PMID: 35841526 (View on PubMed)

Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.

Reference Type: DERIVED

PMID: 33826036 (View on PubMed)

Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.

Reference Type: DERIVED

PMID: 32500294 (View on PubMed)

Other Identifiers

212082PCR4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100857

Identifier Type: -

Identifier Source: org_study_id