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

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.

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Key information

Conditions

Prostate Cancer Castration-resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Site, Algiers, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Factors influencing physician treatment decisions

Time frame: 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

Time frame: up to 72 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study 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

Acronym: ASPIRE-PCa

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Feb 20, 2014
Registry last updated: Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed