NCT05381311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

May 11, 2022

Last Update Submit

November 19, 2024

Conditions

Keywords

prostate cancermetastatic hormone-sensitive prostate cancerobservational

Outcome Measures

Primary Outcomes (1)

  • Log-odds (preference weights) by participant cancer type and country

    Log-odds indicate participants' relative preferences for treatments with each attribute level in the study, all else equal.

    1 day (once through survey)

Secondary Outcomes (1)

  • Relative importance weights by participant type and country

    1 day (once through survey)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Astellas Pharma Global Development, Inc.

    Astellas Pharma Global Development, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 19, 2022

Study Start

September 3, 2021

Primary Completion

December 11, 2022

Study Completion

December 11, 2022

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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/.

Locations