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

NCT06500741 | Completed

• 1 other identifier: 9785-MA-3547
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Novel hormonal therapy; Androgen-deprivation therapy

Outcome Measures

Primary Outcomes (2)

• Patients' Preference weights for different treatment attributes

  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)

  Preference data will be collected via online survey questionnaires designed using DCE method.

  Up to 1 day

Study Arms (1)

Participants

Participants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys.

Other: No Intervention

Interventions

No Intervention OTHER

No investigational drug will be administered to participants in this study.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.

You may not qualify if:

• The patient is castration resistant.
• The patient has metastatic PC.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Analysis Group, Inc.

Boston, Massachusetts, 02199, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: November 22, 2024
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)