Clinical trial NCT02236637: A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care
Official title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Adenocarcinoma of the Prostate
Registry
metastatic castration-resistant prostate cancer
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 3050
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Sequencing of treatment initiation, termination, and duration
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Secondary outcomes:
measure: Clinical Benefit
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
measure: Medical Resource Utilization
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
measure: European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
measure: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
measure: Overall Survival
timeFrame: At treatment initiation/termination or every 3 months from baseline to 3 years
measure: Radiologic Assessment
timeFrame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
measure: Prior prostate cancer treatment
timeFrame: At baseline
measure: Reason for start and rationale for choice of treatment
timeFrame: At treatment initiation during maximum 3 years
measure: Reason for treatment discontinuation
timeFrame: At treatment discontinuation during maximum 3 years
Other outcomes:
Locations:
city: Salzburg
country: Austria
city: Vienna
country: Austria
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Bonheiden
country: Belgium
city: Brasschaat
country: Belgium
city: Brugge
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Liège
country: Belgium
city: Oostende
country: Belgium
city: Ottignies
country: Belgium
city: Roeselare
country: Belgium
city: Turnhout
country: Belgium
city: Angers
country: France
city: Avignon Cedex 9
country: France
city: Brest
country: France
city: Béziers
country: France
city: GAP
country: France
city: Hyeres
country: France
city: La Tronche
country: France
city: Marseille
country: France
city: Metz
country: France
city: Montpellier
country: France
city: Nancy
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Pierre Benite Cedex
country: France
city: Pringy
country: France
city: Reims Cedex
country: France
city: Rennes cedex 09
country: France
city: Saint Mande
country: France
city: St Gregoire Cedex
country: France
city: St Quentin Cedex
country: France
city: Toulouse
country: France
city: Tours Cedex
country: France
city: Augsburg
country: Germany
city: Bad Saarow
country: Germany
city: Bautzen
country: Germany
city: Berlin
country: Germany
city: Braunschweig
country: Germany
city: Chemnitz
country: Germany
city: Duisburg
country: Germany
city: Erkrath
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Holzminden
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Kirchheim
country: Germany
city: Nürtingen
country: Germany
city: Remscheid
country: Germany
city: Reutlingen
country: Germany
city: Rostock
country: Germany
city: Schwerin
country: Germany
city: Sindelfingen
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Weiden
country: Germany
city: Wilhelmshaven
country: Germany
city: Würselen
country: Germany
city: Beer Sheva
country: Israel
city: Beer Yaakov
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Tel-Aviv
country: Israel
city: Luxembourg
country: Luxembourg
city: Niederkorn
country: Luxembourg
city: Bydgoszcz
country: Poland
city: Gdynia
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Opole
country: Poland
city: Poznañ
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Braga
country: Portugal
city: Coimbra
country: Portugal
city: Evora
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Setubal
country: Portugal
city: Ekaterinbourg
country: Russian Federation
city: Moscow N/a
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: St.-Petersburg
country: Russian Federation
city: Ufa
country: Russian Federation
city: Celje
country: Slovenia
city: Ljubljana
country: Slovenia
city: Slovenj Gradec
country: Slovenia
city: Asturias
country: Spain
city: Barakaldo Vizcaya
country: Spain
city: Barcelona
country: Spain
city: Bilbao Vizcaya
country: Spain
city: Girona
country: Spain
city: La Coruña
country: Spain
city: Langreo
country: Spain
city: Palma De Mallorca
country: Spain
city: Pontevedra
country: Spain
city: Sabadell
country: Spain
city: Salamanca
country: Spain
city: Santiago de Compostela
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
city: Borås
country: Sweden
city: Göteborg
country: Sweden
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Västerås
country: Sweden
city: Växjö
country: Sweden
city: Örebro
country: Sweden
city: Östersund
country: Sweden
city: Aarau
country: Switzerland
city: Winterthur
country: Switzerland
city: Ankara
country: Turkey
city: Edirne
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Kocaeli
country: Turkey
city: Turkey
country: Turkey
city: Ashton Under Lyne
country: United Kingdom
city: Barnstaple
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Bradford
country: United Kingdom
city: Brighton Sussex
country: United Kingdom
city: Burton
country: United Kingdom
city: Crewe
country: United Kingdom
city: Huddersfield
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leeds Yorks
country: United Kingdom
city: London
country: United Kingdom
city: N/a N/a
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Scunthorpe
country: United Kingdom
city: Steeton
country: United Kingdom
city: Stoke On Trent
country: United Kingdom
city: Taunton
country: United Kingdom
city: Torquay
country: United Kingdom
city: Wakefield
country: United Kingdom
city: Wigan
country: United Kingdom
city: York
country: United Kingdom
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.