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Clinical Trials/NCT05381311
NCT05381311
Completed
Not Applicable

Prospective Evaluation of Patient Preferences for Outcomes of Hormonal Agents and Chemotherapy in Combination With Androgen Deprivation Therapy

Astellas Pharma Global Development, Inc.1 site in 1 country1,020 target enrollmentSeptember 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Astellas Pharma Global Development, Inc.
Enrollment
1020
Locations
1
Primary Endpoint
Log-odds (preference weights) by participant cancer type and country
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with locally-advanced and metastatic hormone-sensitive prostate cancer (mHSPC). This study will also quantify the importance of administration factors related to convenience relative to treatment outcomes.

Detailed Description

The study will develop and administer a discrete-choice experiment (DCE) to quantify tradeoff preferences of participants with mHSPC and locally-advanced prostate cancer in various countries. Data/surveys are being collected in: United States, Canada, UK, France, Spain, Japan, China and South Korea.

Registry
clinicaltrials.gov
Start Date
September 3, 2021
End Date
December 11, 2022
Last Updated
last year
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For interviews (attribute prioritization and pretest interviews)
  • Diagnosis of mHSPC with or without previous experience with ADT
  • Able to read and understand the survey language
  • Able to provide informed consent For online survey
  • Diagnosis of mHSPC or locally-advanced prostate cancer with or without previous experience with ADT
  • Able to read and understand the survey language
  • Able to provide informed consent

Exclusion Criteria

  • Not applicable

Outcomes

Primary Outcomes

Log-odds (preference weights) by participant cancer type and country

Time Frame: 1 day (once through survey)

Log-odds indicate participants' relative preferences for treatments with each attribute level in the study, all else equal.

Secondary Outcomes

  • Relative importance weights by participant type and country(1 day (once through survey))

Study Sites (1)

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