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

Completed

• Conditions: Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Prostate Cancer

• Registration Number: NCT02066961
• Lead Sponsor: Astellas Pharma Global Development, Inc.

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.

Study Timeline

• Study Start: 2013-12-31
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2019-11-14
• Study Completion: 2019-11-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1533

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site; 🇬🇧 Sunderland, United Kingdom