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

January 10, 2023 updated by: Astellas Pharma Global Development, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants with mHSPC or locally-advanced prostate cancer with or without previous experience with ADT.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (once through survey)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Investigators

  • Study Director: Astellas Pharma Global Development, Inc., Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2021

Primary Completion (Actual)

December 11, 2022

Study Completion (Actual)

December 11, 2022

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9785-MA-3277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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