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)
Status
Conditions
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Volunteers
Inclusion criteria
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Diagnosis of prostate adenocarcinoma
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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
Trial design
1,533 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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