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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02066961




Registration number
NCT02066961
Ethics application status
Date submitted
18/02/2014
Date registered
20/02/2014
Date last updated
20/12/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
ONC-MA-1001
Universal Trial Number (UTN)
Trial acronym
ASPIRE-PCa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Castration-resistant Prostate Cancer 0 0
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patterns of disease management
Timepoint [1] 0 0
up to 72 months
Primary outcome [2] 0 0
Clinical outcomes
Timepoint [2] 0 0
up to 72 months
Secondary outcome [1] 0 0
Factors influencing physician treatment decisions
Timepoint [1] 0 0
up to 72 months
Secondary outcome [2] 0 0
Documentation of healthcare resource utilization used to manage treatment-related complications
Timepoint [2] 0 0
up to 72 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment of metastatic castration-resistant prostate cancer with systemic
chemotherapy

- Life expectancy of <1 year due to comorbidities

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2019
Sample size
Target
Accrual to date
Final
1533
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Site - Port Macquarie
Recruitment hospital [2] 0 0
Site - Tweed Heads
Recruitment hospital [3] 0 0
Site - Kurralta Park
Recruitment hospital [4] 0 0
Site - Parkville
Recruitment hospital [5] 0 0
Site - Richmond
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Algeria
State/province [2] 0 0
Blida
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Cabal
Country [5] 0 0
Argentina
State/province [5] 0 0
La Pampa
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Brazil
State/province [7] 0 0
MG
Country [8] 0 0
Brazil
State/province [8] 0 0
RS
Country [9] 0 0
Brazil
State/province [9] 0 0
SP
Country [10] 0 0
Brazil
State/province [10] 0 0
Caxias do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Santo André
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Colombia
State/province [13] 0 0
DC
Country [14] 0 0
Colombia
State/province [14] 0 0
Cali
Country [15] 0 0
Egypt
State/province [15] 0 0
Cairo
Country [16] 0 0
France
State/province [16] 0 0
Besançon
Country [17] 0 0
France
State/province [17] 0 0
Lille
Country [18] 0 0
France
State/province [18] 0 0
Nimes
Country [19] 0 0
France
State/province [19] 0 0
Pierre Benite
Country [20] 0 0
France
State/province [20] 0 0
Poitiers
Country [21] 0 0
France
State/province [21] 0 0
Saint Mande
Country [22] 0 0
France
State/province [22] 0 0
Suresnes
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
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Germany
State/province [26] 0 0
Jena
Country [27] 0 0
Germany
State/province [27] 0 0
Nürtingen
Country [28] 0 0
Germany
State/province [28] 0 0
Rostock
Country [29] 0 0
Germany
State/province [29] 0 0
Ulm
Country [30] 0 0
Indonesia
State/province [30] 0 0
Jakarta
Country [31] 0 0
Israel
State/province [31] 0 0
Zerifin
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Italy
State/province [34] 0 0
Cremona
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Orbassano
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Anyang
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Incheon
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Suwon
Country [42] 0 0
Lebanon
State/province [42] 0 0
BA
Country [43] 0 0
Mexico
State/province [43] 0 0
Durango
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Nijmegen
Country [46] 0 0
New Zealand
State/province [46] 0 0
Waikato
Country [47] 0 0
New Zealand
State/province [47] 0 0
Christchurch
Country [48] 0 0
New Zealand
State/province [48] 0 0
Tauranga
Country [49] 0 0
Oman
State/province [49] 0 0
Muscat
Country [50] 0 0
Peru
State/province [50] 0 0
Lima
Country [51] 0 0
Philippines
State/province [51] 0 0
Makati
Country [52] 0 0
Philippines
State/province [52] 0 0
Pasig
Country [53] 0 0
Philippines
State/province [53] 0 0
San Juan
Country [54] 0 0
Saudi Arabia
State/province [54] 0 0
Riyadh
Country [55] 0 0
Singapore
State/province [55] 0 0
Singapore
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Sabadell
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taoyuan County
Country [60] 0 0
Taiwan
State/province [60] 0 0
Kaohsiung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taichung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Thailand
State/province [63] 0 0
Bangkok
Country [64] 0 0
Thailand
State/province [64] 0 0
Phayathai
Country [65] 0 0
Thailand
State/province [65] 0 0
Songkla
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Hull
Country [67] 0 0
United Kingdom
State/province [67] 0 0
London
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Newcastle upon Tyne
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02066961
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Senior Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02066961