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Clinical Trials/NCT05381311
NCT05381311CompletedNot 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 enrollmentStarted: September 3, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,020
Locations
1
Primary Endpoint
Log-odds (preference weights) by participant cancer type and country

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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