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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381311
• Other study ID #: 9785-MA-3277
• Status: Completed
• Start date: September 3, 2021
• Est. completion date: December 11, 2022

Study information

• Verified date: January 2023
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: December 11, 2022
• Est. primary completion date: December 11, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Metastatic Hormone-sensitive Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log-odds (preference weights) by participant cancer type and country	Log-odds indicate participants' relative preferences for treatments with each attribute level in the study, all else equal.	1 day (once through survey)
Secondary	Relative importance weights by participant type and country	These weights indicate the overall influence of each study attribute on choice.	1 day (once through survey)