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Completed

NCT Number: NCT05381311

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Hormone-sensitive Prostate Cancer Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

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Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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