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

7 november 2019 uppdaterad av: Janssen Pharmaceutica N.V., Belgium

A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

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.

Studieöversikt

Status

Avslutad

Betingelser

Prostatacancer

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

3050

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Belgien
- - Aalst, Belgien
  - Antwerpen, Belgien
  - Bonheiden, Belgien
  - Brasschaat, Belgien
  - Brugge, Belgien
  - Edegem, Belgien
  - Gent, Belgien
  - Kortrijk, Belgien
  - Liège, Belgien
  - Oostende, Belgien
  - Ottignies, Belgien
  - Roeselare, Belgien
  - Turnhout, Belgien
Frankrike
- - Angers, Frankrike
  - Avignon Cedex 9, Frankrike
  - Brest, Frankrike
  - Béziers, Frankrike
  - GAP, Frankrike
  - Hyeres, Frankrike
  - La Tronche, Frankrike
  - Marseille, Frankrike
  - Metz, Frankrike
  - Montpellier, Frankrike
  - Nancy, Frankrike
  - Paris, Frankrike
  - Perigueux, Frankrike
  - Pierre Benite Cedex, Frankrike
  - Pringy, Frankrike
  - Reims Cedex, Frankrike
  - Rennes cedex 09, Frankrike
  - Saint Mande, Frankrike
  - St Gregoire Cedex, Frankrike
  - St Quentin Cedex, Frankrike
  - Toulouse, Frankrike
  - Tours Cedex, Frankrike
Israel
- - Beer Sheva, Israel
  - Beer Yaakov, Israel
  - Haifa, Israel
  - Holon, Israel
  - Tel-Aviv, Israel
Kalkon
- - Ankara, Kalkon
  - Edirne, Kalkon
  - Istanbul, Kalkon
  - Izmir, Kalkon
  - Kayseri, Kalkon
  - Kocaeli, Kalkon
  - Turkey, Kalkon
Luxemburg
- - Luxembourg, Luxemburg
  - Niederkorn, Luxemburg
Polen
- - Bydgoszcz, Polen
  - Gdynia, Polen
  - Krakow, Polen
  - Lodz, Polen
  - Opole, Polen
  - Poznañ, Polen
  - Warsaw, Polen
  - Warszawa, Polen
Portugal
- - Braga, Portugal
  - Coimbra, Portugal
  - Evora, Portugal
  - Lisboa, Portugal
  - Porto, Portugal
  - Setubal, Portugal
Ryska Federationen
- - Ekaterinbourg, Ryska Federationen
  - Moscow N/a, Ryska Federationen
  - Obninsk, Ryska Federationen
  - Omsk, Ryska Federationen
  - Rostov-on-Don, Ryska Federationen
  - St.-Petersburg, Ryska Federationen
  - Ufa, Ryska Federationen
Schweiz
- - Aarau, Schweiz
  - Winterthur, Schweiz
Slovenien
- - Celje, Slovenien
  - Ljubljana, Slovenien
  - Slovenj Gradec, Slovenien
Spanien
- - Asturias, Spanien
  - Barakaldo Vizcaya, Spanien
  - Barcelona, Spanien
  - Bilbao Vizcaya, Spanien
  - Girona, Spanien
  - La Coruña, Spanien
  - Langreo, Spanien
  - Palma De Mallorca, Spanien
  - Pontevedra, Spanien
  - Sabadell, Spanien
  - Salamanca, Spanien
  - Santiago de Compostela, Spanien
  - Valladolid, Spanien
  - Zaragoza, Spanien
Storbritannien
- - Ashton Under Lyne, Storbritannien
  - Barnstaple, Storbritannien
  - Blackburn, Storbritannien
  - Bournemouth, Storbritannien
  - Bradford, Storbritannien
  - Brighton Sussex, Storbritannien
  - Burton, Storbritannien
  - Crewe, Storbritannien
  - Huddersfield, Storbritannien
  - Lancaster, Storbritannien
  - Leeds Yorks, Storbritannien
  - London, Storbritannien
  - N/a N/a, Storbritannien
  - Plymouth, Storbritannien
  - Scunthorpe, Storbritannien
  - Steeton, Storbritannien
  - Stoke On Trent, Storbritannien
  - Taunton, Storbritannien
  - Torquay, Storbritannien
  - Wakefield, Storbritannien
  - Wigan, Storbritannien
  - York, Storbritannien
Sverige
- - Borås, Sverige
  - Göteborg, Sverige
  - Malmö, Sverige
  - Stockholm, Sverige
  - Umeå, Sverige
  - Västerås, Sverige
  - Växjö, Sverige
  - Örebro, Sverige
  - Östersund, Sverige
Tyskland
- - Augsburg, Tyskland
  - Bad Saarow, Tyskland
  - Bautzen, Tyskland
  - Berlin, Tyskland
  - Braunschweig, Tyskland
  - Chemnitz, Tyskland
  - Duisburg, Tyskland
  - Erkrath, Tyskland
  - Frankfurt, Tyskland
  - Hamburg, Tyskland
  - Holzminden, Tyskland
  - Jena, Tyskland
  - Kiel, Tyskland
  - Kirchheim, Tyskland
  - Nürtingen, Tyskland
  - Remscheid, Tyskland
  - Reutlingen, Tyskland
  - Rostock, Tyskland
  - Schwerin, Tyskland
  - Sindelfingen, Tyskland
  - Tübingen, Tyskland
  - Ulm, Tyskland
  - Weiden, Tyskland
  - Wilhelmshaven, Tyskland
  - Würselen, Tyskland
Österrike
- - Salzburg, Österrike
  - Vienna, Österrike

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Sannolikhetsprov

Studera befolkning

Approximately 3,000 patients will be enrolled in this registry. Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance. Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
mCRPC patients Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Sequencing of treatment initiation, termination, and duration Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Clinical Benefit Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Medical Resource Utilization Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L)) Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival Tidsram: At treatment initiation/termination or every 3 months from baseline to 3 years		At treatment initiation/termination or every 3 months from baseline to 3 years
Radiologic Assessment Tidsram: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Prior prostate cancer treatment Tidsram: At baseline	Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.	At baseline
Reason for start and rationale for choice of treatment Tidsram: At treatment initiation during maximum 3 years		At treatment initiation during maximum 3 years
Reason for treatment discontinuation Tidsram: At treatment discontinuation during maximum 3 years		At treatment discontinuation during maximum 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 juni 2013

Primärt slutförande (Faktisk)

21 november 2018

Avslutad studie (Faktisk)

21 november 2018

Studieregistreringsdatum

Först inskickad

8 september 2014

Först inskickad som uppfyllde QC-kriterierna

9 september 2014

Första postat (Uppskatta)

10 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

CR100857
212082PCR4001 (Annan identifierare: Janssen Pharmaceutica NV - CTMS ID)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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