Clinical trial NCT02066961: A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
Official title: A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
Keywords: metastatic prostate cancer
castration-resistant prostate cancer
prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-02-20
Enrollment: 1533
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.

Brief summary: The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

Detailed description: Each subject will be followed from the time of enrollment for a minimum of 3 years and a maximum of up to 6 years or until death, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of prostate adenocarcinoma
* Will receive a new intervention at the time of study entry, for the treatment of:

  * Biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50 ng/mL (2 consecutive values) within 6 months prior to study entry; or
  * Castration-resistant prostate cancer; or
  * Metastatic prostate cancer at initial diagnosis of prostate cancer

Exclusion Criteria:

* Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
* Life expectancy of \<1 year due to comorbidities

Primary outcomes:
measure: Patterns of disease management
timeFrame: up to 72 months
measure: Clinical outcomes
timeFrame: up to 72 months
Secondary outcomes:
measure: Factors influencing physician treatment decisions
timeFrame: up to 72 months
measure: Documentation of healthcare resource utilization used to manage treatment-related complications
timeFrame: up to 72 months
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Site
city: Algiers
country: Algeria
facility: Site
city: Blida
country: Algeria
facility: Site
city: Buenos Aires
country: Argentina
facility: Site
city: Cabal
country: Argentina
facility: Site
city: La Pampa
country: Argentina
facility: Site
city: Port Macquarie
country: Australia
facility: Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Site
state: New South Wales
city: Kurralta Park
country: Australia
facility: Site
state: South Australia
city: Parkville
country: Australia
facility: Site
state: Victoria
city: Richmond
country: Australia
facility: Site
state: Victoria
city: Wien
country: Austria
facility: Site
city: Belo Horizonte
country: Brazil
facility: Site
state: MG
city: Ijuí
country: Brazil
facility: Site
state: RS
city: Passo Fundo
country: Brazil
facility: Site
state: RS
city: Porto Alegre
country: Brazil
facility: Site
state: RS
city: São Paulo
country: Brazil
facility: Site
state: SP
city: Caxias do Sul
country: Brazil
facility: Site
city: Santo André
country: Brazil
facility: Site
city: Granby
country: Canada
facility: Site
state: Quebec
city: Quebec
country: Canada
facility: Site
city: Bogota
country: Colombia
facility: Site
state: DC
city: Bogotá
country: Colombia
facility: Site
state: DC
city: Cali
country: Colombia
facility: Site
city: Cairo
country: Egypt
facility: Site
city: Cairo
country: Egypt
facility: Site
city: Cairo
country: Egypt
facility: Site
city: Besançon
country: France
facility: Site
city: Lille
country: France
facility: Site
city: Nimes
country: France
facility: Site
city: Pierre Benite
country: France
facility: Site
city: Poitiers
country: France
facility: Site
city: Saint Mande
country: France
facility: Site
city: Suresnes
country: France
facility: Site
city: Berlin
country: Germany
facility: Site
city: Freiburg
country: Germany
facility: Site
city: Hamburg
country: Germany
facility: Site
city: Jena
country: Germany
facility: Site
city: Nürtingen
country: Germany
facility: Site
city: Rostock
country: Germany
facility: Site
city: Ulm
country: Germany
facility: Site
city: Jakarta
country: Indonesia
facility: Site
city: Beer Ya'akov
country: Israel
facility: Site
state: Zerifin
city: Haifa
country: Israel
facility: Site
city: Brescia
country: Italy
facility: Site
city: Cremona
country: Italy
facility: Site
city: Milano
country: Italy
facility: Site
city: Orbassano
country: Italy
facility: Site
city: Anyang
country: Korea, Republic of
facility: Site
city: Busan
country: Korea, Republic of
facility: Site
city: Busan
country: Korea, Republic of
facility: Site
city: Incheon
country: Korea, Republic of
facility: Site
city: Seoul
country: Korea, Republic of
facility: Site
city: Seoul
country: Korea, Republic of
facility: Site
city: Seoul
country: Korea, Republic of
facility: Site
city: Suwon
country: Korea, Republic of
facility: Site
city: Beirut
country: Lebanon
facility: Site
state: BA
city: Beirut
country: Lebanon
facility: Site
state: BA
city: Durango
country: Mexico
facility: Site
city: Amsterdam
country: Netherlands
facility: Site
city: Nijmegen
country: Netherlands
facility: Site
city: Hamilton
country: New Zealand
facility: Site
state: Waikato
city: Christchurch
country: New Zealand
facility: Site
city: Tauranga
country: New Zealand
facility: Site
city: Tauranga
country: New Zealand
facility: Site
city: Muscat
country: Oman
facility: Site
city: Miraflores
country: Peru
facility: Site
state: Lima
city: Lima
country: Peru
facility: Site
city: Lima
country: Peru
facility: Site
city: Makati
country: Philippines
facility: Site
city: Pasig
country: Philippines
facility: Site
city: San Juan
country: Philippines
facility: Site
city: Riyadh
country: Saudi Arabia
facility: Site
city: Singapore
country: Singapore
facility: Site
city: Singapore
country: Singapore
facility: Site
city: Singapore
country: Singapore
facility: Site
city: Singapore
country: Singapore
facility: Site
city: Vall d'Hebron 119-129
country: Spain
facility: Site
state: Barcelona
city: Madrid
country: Spain
facility: Site
city: Sabadell
country: Spain
facility: Site
city: Guishan Township
country: Taiwan
facility: Site
state: Taoyuan County
city: Kaohsiung
country: Taiwan
facility: Site
city: Kaohsiung
country: Taiwan
facility: Site
city: Taichung
country: Taiwan
facility: Site
city: Taipei
country: Taiwan
facility: Site
city: Taipei
country: Taiwan
facility: Site
city: Bangkok
country: Thailand
facility: Site
city: Phayathai
country: Thailand
facility: Site
city: Songkla
country: Thailand
facility: Site
city: Hull
country: United Kingdom
facility: Site
city: London
country: United Kingdom
facility: Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Site
city: Sunderland
country: United Kingdom
facility: Site
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Senior Medical Director
role: STUDY_DIRECTOR
References: