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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02066961

Acronym

ASPIRE-PCa

Enrollment

1533

Registered

2014-02-20

Start date

2013-12-31

Completion date

2019-11-14

Last updated

2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration-resistant Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer

Keywords

metastatic prostate cancer, castration-resistant prostate cancer, prostate cancer

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patterns of disease management	up to 72 months	Description of disease assessment methods, physician referral patterns and treatments
Clinical outcomes	up to 72 months	Evidence of disease progression and development of symptomatic disease

Secondary

Measure	Time frame	Description
Factors influencing physician treatment decisions	up to 72 months	Reason/s for treatment choices and trigger/s for treatment changes
Documentation of healthcare resource utilization used to manage treatment-related complications	up to 72 months	—

Countries

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

Outcome results