Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study

Completed

• Conditions: Prostate Cancer; Metastatic Hormone-sensitive Prostate Cancer

• Registration Number: NCT05381311
• Lead Sponsor: Astellas Pharma Global Development, Inc.

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 Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-19
• Primary Completion: 2022-12-11
• Study Completion: 2022-12-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1020

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Log-odds (preference weights) by participant cancer type and country	1 day (once through survey)	Log-odds indicate participants' relative preferences for treatments with each attribute level in the study, all else equal.

Secondary Outcome Measures

Name	Time	Method
Relative importance weights by participant type and country	1 day (once through survey)	These weights indicate the overall influence of each study attribute on choice.

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States