Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients

May 2, 2025 updated by: Astellas Pharma Global Development, Inc.

Discrete Choice Experiment to Assess the Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Patients With Prostate Cancer

The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.

Study Type

Observational

Enrollment (Actual)

374

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02199
        • Analysis Group, Inc.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult prostate cancer patients and urologists or oncologists who have cared for at least ten non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients in the past year.

Description

Inclusion Criteria:

Physician inclusion criteria

  • The physician is a certified urologist or oncologist. The final selection will be adjusted to local practice.
  • The physician has cared for at least ten nmHSPC patients in the past year.
  • The physician has experience prescribing NHT and ADT. Patient inclusion criteria
  • The patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.

Exclusion Criteria:

Physician exclusion criteria

  • None Patient exclusion criteria
  • The patient is castration resistant.
  • The patient has metastatic PC.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Participants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys.
Other: No Intervention
No investigational drug will be administered to participants in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Preference weights for different treatment attributes
Time Frame: Up to 1 day
Preference data will be collected via online survey questionnaires designed using DCE method.
Up to 1 day
Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy)
Time Frame: Up to 1 day
Preference data will be collected via online survey questionnaires designed using DCE method.
Up to 1 day

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: Medical Director, 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)

November 22, 2024

Primary Completion (Actual)

April 2, 2025

Study Completion (Actual)

April 2, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9785-MA-3547

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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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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