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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Subjects with biochemical failure experience after primary treatment and have high-risk disease | |
| Cohort 2<br>Subjects with a medical diagnosis of castration-resistant prostate cancer | |
| Cohort 3<br>Subjects with an initial diagnosis of metastatic prostate cancer | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic prostate cancer, castration-resistant prostate cancer, prostate cancer