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
ASPIRE-PCa
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
1 other identifier
observational
1,533
26 countries
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2013
Longer than P75 for all trials
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2013
CompletedFirst Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2019
CompletedDecember 20, 2019
December 1, 2019
5.9 years
February 18, 2014
December 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patterns of disease management
Description of disease assessment methods, physician referral patterns and treatments
up to 72 months
Clinical outcomes
Evidence of disease progression and development of symptomatic disease
up to 72 months
Secondary Outcomes (2)
Factors influencing physician treatment decisions
up to 72 months
Documentation of healthcare resource utilization used to manage treatment-related complications
up to 72 months
Study Arms (3)
Cohort 1
Subjects with biochemical failure experience after primary treatment and have high-risk disease
Cohort 2
Subjects with a medical diagnosis of castration-resistant prostate cancer
Cohort 3
Subjects with an initial diagnosis of metastatic prostate cancer
Eligibility Criteria
Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.
You may qualify if:
- 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
You may not qualify if:
- Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
- Life expectancy of \<1 year due to comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Site
Algiers, 16005, Algeria
Site
Algiers, 16006, Algeria
Site
Blida, BP 190, Algeria
Site
Buenos Aires, 1060, Argentina
Site
La Pampa, 6300, Argentina
Site
Paraje Cabal, C1120AAT, Argentina
Site
Port Macquarie, New South Wales, 2444, Australia
Site
Tweed Heads, New South Wales, 2485, Australia
Site
Kurralta Park, South Australia, 5037, Australia
Site
Parkville, Victoria, 3050, Australia
Site
Richmond, Victoria, 3121, Australia
Site
Vienna, 1090, Austria
Site
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Site
IjuĂ, Rio Grande do Sul, 98700-000, Brazil
Site
Passo Fundo, Rio Grande do Sul, Brazil
Site
Porto Alegre, Rio Grande do Sul, 90110, Brazil
Site
SĂ£o Paulo, SĂ£o Paulo, 01246-000, Brazil
Site
Caxias do Sul, 95070-560, Brazil
Site
Santo André, 09060-650, Brazil
Site
Granby, Quebec, J2G8Z9, Canada
Site
Québec, Quebec, G1R 2J6, Canada
Site
BogotĂ¡, DC, 110221, Colombia
Site
BogotĂ¡, DC, 111321, Colombia
Site
Cali, 76001, Colombia
Site
Cairo, 11566, Egypt
Site
Cairo, 11796, Egypt
Site
Cairo, 12411, Egypt
Site
Besançon, 25030, France
Site
Lille, 59037, France
Site
Nîmes, 30029, France
Site
Pierre-BĂ©nite, 69310, France
Site
Poitiers, 86021, France
Site
Saint-Mandé, 94163, France
Site
Suresnes, 92151, France
Site
Berlin, 14197, Germany
Site
Freiburg im Breisgau, 79106, Germany
Site
Hamburg, 20246, Germany
Site
Jena, 7743, Germany
Site
NĂ¼rtingen, 72622, Germany
Site
Rostock, 18107, Germany
Site
Ulm, 89075, Germany
Site
Jakarta, 10430, Indonesia
Site
Beer Ya'akov, Zerifin, 70300, Israel
Site
Haifa, 31096, Israel
Site
Brescia, 25123, Italy
Site
Cremona, 26100, Italy
Site
Milan, 20133, Italy
Site
Orbassano, 10043, Italy
Site
Beirut, BA, 116301, Lebanon
Site
Beirut, BA, 166830, Lebanon
Site
Durango, 34000, Mexico
Site
Amsterdam, 1105 AZ, Netherlands
Site
Nijmegen, 6525 GA, Netherlands
Site
Hamilton, Waikato Region, 3204, New Zealand
Site
Christchurch, 8013, New Zealand
Site
Tauranga, 3140, New Zealand
Site
Tauranga, 622, New Zealand
Site
Muscat, Oman
Site
Miraflores, Lima region, Lima18, Peru
Site
Lima, Lima 01, Peru
Site
Lima, Lima 18, Peru
Site
Makati, 1229, Philippines
Site
Pasig, 1600, Philippines
Site
San Juan City, 1502, Philippines
Site
Riyadh, 11411, Saudi Arabia
Site
Singapore, 119228, Singapore
Site
Singapore, 169610, Singapore
Site
Singapore, 258499, Singapore
Site
Singapore, 308433, Singapore
Site
Anyang, 431-070, South Korea
Site
Busan, 602-714, South Korea
Site
Busan, 602739, South Korea
Site
Incheon, 405-760, South Korea
Site
Seoul, 110-746, South Korea
Site
Seoul, 137-701, South Korea
Site
Seoul, 139-872, South Korea
Site
Suwon, 442-723, South Korea
Site
Vall d'Hebron 119-129, Barcelona, 8035, Spain
Site
Madrid, 28050, Spain
Site
Sabadell, 8208, Spain
Site
Guishan Township, Taoyuan County, 333, Taiwan
Site
Kaohsiung City, 807, Taiwan
Site
Kaohsiung City, 81362, Taiwan
Site
Taichung, 40447, Taiwan
Site
Taipei, 10002, Taiwan
Site
Taipei, 11211, Taiwan
Site
Bangkok, 10400, Thailand
Site
Phayathai, 10400, Thailand
Site
Songkhla, 90110, Thailand
Site
Hull, HU17 8SX, United Kingdom
Site
London, SE1 9RT, United Kingdom
Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
Site
Sunderland, SR4 7TP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2014
First Posted
February 20, 2014
Study Start
December 31, 2013
Primary Completion
November 14, 2019
Study Completion
November 14, 2019
Last Updated
December 20, 2019
Record last verified: 2019-12