Prostate CancerASPIRE-PCaNCT02066961
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
An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 93 sites in 27 countries.
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
- How many people
- 1,533 participants
- Where
- 93 sitesin 27 countries
- Study dates
- 31 Dec 2013to 14 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.
Who may be able to join
- 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
Who cannot join
- Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
- Life expectancy of <1 year due to comorbidities
Trial locations and contacts
93 sites in 27 countries.
93 sites in 27 countries
South Korea8 sites
Site
Anyang, 431-070
Site
Busan, 602-714
Site
Busan, 602739
Site
Incheon, 405-760
Site
Seoul, 110-746
Site
Seoul, 137-701
Site
Seoul, 139-872
Site
Suwon, 442-723
Brazil7 sites
Site
Belo Horizonte, Minas Gerais, 30130-100
Site
Caxias do Sul, 95070-560
Site
Ijuí, Rio Grande do Sul, 98700-000
Site
Passo Fundo, Rio Grande do Sul
Site
Porto Alegre, Rio Grande do Sul, 90110
Site
Santo André, 09060-650
Site
São Paulo, São Paulo, 01246-000
France7 sites
Site
Besançon, 25030
Site
Lille, 59037
Site
Nîmes, 30029
Site
Pierre-Bénite, 69310
Site
Poitiers, 86021
Site
Saint-Mandé, 94163
Site
Suresnes, 92151
Germany7 sites
Site
Berlin, 14197
Site
Freiburg im Breisgau, 79106
Site
Hamburg, 20246
Site
Jena, 7743
Site
Nürtingen, 72622
Site
Rostock, 18107
Site
Ulm, 89075
Taiwan6 sites
Site
Guishan Township, Taoyuan County, 333
Site
Kaohsiung City, 807
Site
Kaohsiung City, 81362
Site
Taichung, 40447
Site
Taipei, 10002
Site
Taipei, 11211
Australia5 sites
Site
Kurralta Park, South Australia, 5037
Site
Parkville, Victoria, 3050
Site
Port Macquarie, New South Wales, 2444
Site
Richmond, Victoria, 3121
Site
Tweed Heads, New South Wales, 2485
Italy4 sites
Site
Brescia, 25123
Site
Cremona, 26100
Site
Milan, 20133
Site
Orbassano, 10043
New Zealand4 sites
Site
Christchurch, 8013
Site
Hamilton, Waikato Region, 3204
Site
Tauranga, 3140
Site
Tauranga, 622
Singapore4 sites
Site
Singapore, 119228
Site
Singapore, 169610
Site
Singapore, 258499
Site
Singapore, 308433
United Kingdom4 sites
Site
Hull, HU17 8SX
Site
London, SE1 9RT
Site
Newcastle upon Tyne, NE7 7DN
Site
Sunderland, SR4 7TP
Argentina3 sites
Site
Buenos Aires, 1060
Site
La Pampa, 6300
Site
Paraje Cabal, C1120AAT
Colombia3 sites
Site
Bogotá, DC, 110221
Site
Bogotá, DC, 111321
Site
Cali, 76001
Peru3 sites
Site
Lima, Lima 01
Site
Lima, Lima 18
Site
Miraflores, Lima region, Lima18
Philippines3 sites
Site
Makati, 1229
Site
Pasig, 1600
Site
San Juan City, 1502
Spain3 sites
Site
Madrid, 28050
Site
Sabadell, 8208
Site
Vall d'Hebron 119-129, Barcelona, 8035
About this study
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
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.
Read the 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.
- Keywords
- metastatic prostate cancer, castration-resistant prostate cancer, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of disease management
Description of disease assessment methods, physician referral patterns and treatments
Measured: up to 72 months
Clinical outcomes
Evidence of disease progression and development of symptomatic disease
Measured: up to 72 months
Secondary outcomes (2)
Factors influencing physician treatment decisions
Reason/s for treatment choices and trigger/s for treatment changes
Measured: up to 72 months
Documentation of healthcare resource utilization used to manage treatment-related complications
Measured: up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start31 Dec 2013
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066961
- Sponsor's protocol ID
- ONC-MA-1001
- Acronym
- ASPIRE-PCa
- Status last verified
- Dec 2019
- First submitted
- 18 Feb 2014
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02066961
- Acronym / sponsor ID
- ASPIRE-PCa / ONC-MA-1001
- Keywords
- metastatic prostate cancer, castration-resistant prostate cancer, prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,533 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2013 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.
Key inclusion criteria (5 listed)
- Diagnosis of prostate adenocarcinoma
- Will receive a new intervention at the time of study entry, for the treatment of:
Key exclusion criteria (2 listed)
- Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
- Life expectancy of <1 year due to comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patterns of disease management
Time frame: up to 72 months
Description of disease assessment methods, physician referral patterns and treatments
Clinical outcomes
Time frame: up to 72 months
Evidence of disease progression and development of symptomatic disease
2 secondary outcomes
Factors influencing physician treatment decisions
Time frame: up to 72 months
Documentation of healthcare resource utilization used to manage treatment-related complications
Time frame: up to 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
93 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 93 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in South Korea, Brazil, France, Germany, Taiwan and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of disease management (time frame: up to 72 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.