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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: No Intervention

• Registration Number: NCT06500741
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

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).

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 Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-11-22
• Status Verified: 2025-04
• Primary Completion: 2025-04-02
• Study Completion: 2025-04-02
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 374

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	No Intervention	Participants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Analysis Group, Inc.; 🇺🇸 Boston, Massachusetts, United States