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

Prostate Cancer Clinical Trial

— ASPIRE-PCa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066961
• Other study ID #: ONC-MA-1001
• Status: Completed
• Start date: December 31, 2013
• Est. completion date: November 14, 2019

Study information

• Verified date: December 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1533
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Metastatic Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Algeria	Site	Algiers
Algeria	Site	Algiers
Algeria	Site	Blida
Argentina	Site	Buenos Aires
Argentina	Site	Cabal
Argentina	Site	La Pampa
Australia	Site	Kurralta Park	South Australia
Australia	Site	Parkville	Victoria
Australia	Site	Port Macquarie	New South Wales
Australia	Site	Richmond	Victoria
Australia	Site	Tweed Heads	New South Wales
Austria	Site	Wien
Brazil	Site	Belo Horizonte	MG
Brazil	Site	Caxias do Sul
Brazil	Site	Ijuí	RS
Brazil	Site	Passo Fundo	RS
Brazil	Site	Porto Alegre	RS
Brazil	Site	Santo André
Brazil	Site	São Paulo	SP
Canada	Site	Granby	Quebec
Canada	Site	Quebec
Colombia	Site	Bogota	DC
Colombia	Site	Bogotá	DC
Colombia	Site	Cali
Egypt	Site	Cairo
Egypt	Site	Cairo
Egypt	Site	Cairo
France	Site	Besançon
France	Site	Lille
France	Site	Nimes
France	Site	Pierre Benite
France	Site	Poitiers
France	Site	Saint Mande
France	Site	Suresnes
Germany	Site	Berlin
Germany	Site	Freiburg
Germany	Site	Hamburg
Germany	Site	Jena
Germany	Site	Nürtingen
Germany	Site	Rostock
Germany	Site	Ulm
Indonesia	Site	Jakarta
Israel	Site	Beer Ya'akov	Zerifin
Israel	Site	Haifa
Italy	Site	Brescia
Italy	Site	Cremona
Italy	Site	Milano
Italy	Site	Orbassano
Korea, Republic of	Site	Anyang
Korea, Republic of	Site	Busan
Korea, Republic of	Site	Busan
Korea, Republic of	Site	Incheon
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Seoul
Korea, Republic of	Site	Suwon
Lebanon	Site	Beirut	BA
Lebanon	Site	Beirut	BA
Mexico	Site	Durango
Netherlands	Site	Amsterdam
Netherlands	Site	Nijmegen
New Zealand	Site	Christchurch
New Zealand	Site	Hamilton	Waikato
New Zealand	Site	Tauranga
New Zealand	Site	Tauranga
Oman	Site	Muscat
Peru	Site	Lima
Peru	Site	Lima
Peru	Site	Miraflores	Lima
Philippines	Site	Makati
Philippines	Site	Pasig
Philippines	Site	San Juan
Saudi Arabia	Site	Riyadh
Singapore	Site	Singapore
Singapore	Site	Singapore
Singapore	Site	Singapore
Singapore	Site	Singapore
Spain	Site	Madrid
Spain	Site	Sabadell
Spain	Site	Vall d'Hebron 119-129	Barcelona
Taiwan	Site	Guishan Township	Taoyuan County
Taiwan	Site	Kaohsiung
Taiwan	Site	Kaohsiung
Taiwan	Site	Taichung
Taiwan	Site	Taipei
Taiwan	Site	Taipei
Thailand	Site	Bangkok
Thailand	Site	Phayathai
Thailand	Site	Songkla
United Kingdom	Site	Hull
United Kingdom	Site	London
United Kingdom	Site	Newcastle upon Tyne
United Kingdom	Site	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

Algeria,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Colombia,  Egypt,  France,  Germany,  Indonesia,  Israel,  Italy,  Korea, Republic of,  Lebanon,  Mexico,  Netherlands,  New Zealand,  Oman,  Peru,  Philippines,  Saudi Arabia,  Singapore,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of disease management	Description of disease assessment methods, physician referral patterns and treatments	up to 72 months
Primary	Clinical outcomes	Evidence of disease progression and development of symptomatic disease	up to 72 months
Secondary	Factors influencing physician treatment decisions	Reason/s for treatment choices and trigger/s for treatment changes	up to 72 months
Secondary	Documentation of healthcare resource utilization used to manage treatment-related complications		up to 72 months