- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02236637
A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care
A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Aalst, Belgia
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Antwerpen, Belgia
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Bonheiden, Belgia
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Brasschaat, Belgia
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Brugge, Belgia
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Edegem, Belgia
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Gent, Belgia
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Kortrijk, Belgia
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Liège, Belgia
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Oostende, Belgia
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Ottignies, Belgia
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Roeselare, Belgia
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Turnhout, Belgia
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Ekaterinbourg, Den russiske føderasjonen
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Moscow N/a, Den russiske føderasjonen
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Obninsk, Den russiske føderasjonen
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Omsk, Den russiske føderasjonen
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Rostov-on-Don, Den russiske føderasjonen
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St.-Petersburg, Den russiske føderasjonen
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Ufa, Den russiske føderasjonen
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Angers, Frankrike
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Avignon Cedex 9, Frankrike
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Brest, Frankrike
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Béziers, Frankrike
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GAP, Frankrike
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Hyeres, Frankrike
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La Tronche, Frankrike
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Marseille, Frankrike
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Metz, Frankrike
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Montpellier, Frankrike
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Nancy, Frankrike
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Paris, Frankrike
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Perigueux, Frankrike
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Pierre Benite Cedex, Frankrike
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Pringy, Frankrike
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Reims Cedex, Frankrike
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Rennes cedex 09, Frankrike
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Saint Mande, Frankrike
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St Gregoire Cedex, Frankrike
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St Quentin Cedex, Frankrike
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Toulouse, Frankrike
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Tours Cedex, Frankrike
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Beer Sheva, Israel
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Beer Yaakov, Israel
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Haifa, Israel
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Holon, Israel
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Tel-Aviv, Israel
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Luxembourg, Luxembourg
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Niederkorn, Luxembourg
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Bydgoszcz, Polen
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Gdynia, Polen
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Krakow, Polen
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Lodz, Polen
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Opole, Polen
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Poznañ, Polen
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Warsaw, Polen
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Warszawa, Polen
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Braga, Portugal
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Coimbra, Portugal
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Evora, Portugal
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Lisboa, Portugal
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Porto, Portugal
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Setubal, Portugal
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Celje, Slovenia
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Ljubljana, Slovenia
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Slovenj Gradec, Slovenia
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Asturias, Spania
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Barakaldo Vizcaya, Spania
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Barcelona, Spania
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Bilbao Vizcaya, Spania
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Girona, Spania
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La Coruña, Spania
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Langreo, Spania
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Palma De Mallorca, Spania
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Pontevedra, Spania
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Sabadell, Spania
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Salamanca, Spania
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Santiago de Compostela, Spania
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Valladolid, Spania
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Zaragoza, Spania
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Ashton Under Lyne, Storbritannia
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Barnstaple, Storbritannia
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Blackburn, Storbritannia
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Bournemouth, Storbritannia
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Bradford, Storbritannia
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Brighton Sussex, Storbritannia
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Burton, Storbritannia
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Crewe, Storbritannia
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Huddersfield, Storbritannia
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Lancaster, Storbritannia
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Leeds Yorks, Storbritannia
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London, Storbritannia
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N/a N/a, Storbritannia
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Plymouth, Storbritannia
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Scunthorpe, Storbritannia
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Steeton, Storbritannia
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Stoke On Trent, Storbritannia
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Taunton, Storbritannia
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Torquay, Storbritannia
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Wakefield, Storbritannia
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Wigan, Storbritannia
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York, Storbritannia
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Aarau, Sveits
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Winterthur, Sveits
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Borås, Sverige
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Göteborg, Sverige
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Malmö, Sverige
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Stockholm, Sverige
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Umeå, Sverige
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Västerås, Sverige
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Växjö, Sverige
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Örebro, Sverige
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Östersund, Sverige
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Ankara, Tyrkia
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Edirne, Tyrkia
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Istanbul, Tyrkia
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Izmir, Tyrkia
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Kayseri, Tyrkia
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Kocaeli, Tyrkia
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Turkey, Tyrkia
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Augsburg, Tyskland
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Bad Saarow, Tyskland
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Bautzen, Tyskland
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Berlin, Tyskland
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Braunschweig, Tyskland
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Chemnitz, Tyskland
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Duisburg, Tyskland
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Erkrath, Tyskland
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Frankfurt, Tyskland
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Hamburg, Tyskland
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Holzminden, Tyskland
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Jena, Tyskland
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Kiel, Tyskland
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Kirchheim, Tyskland
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Nürtingen, Tyskland
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Remscheid, Tyskland
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Reutlingen, Tyskland
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Rostock, Tyskland
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Schwerin, Tyskland
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Sindelfingen, Tyskland
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Tübingen, Tyskland
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Ulm, Tyskland
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Weiden, Tyskland
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Wilhelmshaven, Tyskland
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Würselen, Tyskland
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Salzburg, Østerrike
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Vienna, Østerrike
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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mCRPC patients
Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Sequencing of treatment initiation, termination, and duration
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinical Benefit
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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).
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Medical Resource Utilization
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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'.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Overall Survival
Tidsramme: At treatment initiation/termination or every 3 months from baseline to 3 years
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At treatment initiation/termination or every 3 months from baseline to 3 years
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Radiologic Assessment
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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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.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Prior prostate cancer treatment
Tidsramme: At baseline
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Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.
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At baseline
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Reason for start and rationale for choice of treatment
Tidsramme: At treatment initiation during maximum 3 years
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At treatment initiation during maximum 3 years
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Reason for treatment discontinuation
Tidsramme: At treatment discontinuation during maximum 3 years
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At treatment discontinuation during maximum 3 years
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR100857
- 212082PCR4001 (Annen identifikator: Janssen Pharmaceutica NV - CTMS ID)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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