NCT07074405

Brief Summary

This study investigates the acceptability of artificial intelligence (AI) as a diagnostic support tool among patients with localized prostate cancer and healthcare providers, as well as their willingness to share health data for AI development. Background AI tools in healthcare show promising potential, especially in improving diagnosis accuracy and personalizing treatment. However, successful implementation depends not only on technical performance but also on the acceptability of AI among its users-both patients and professionals. Prior research has shown varied acceptability depending on context, disease severity, task performed by AI, and user population. Objectives Assess patients' acceptability of AI as a diagnostic support in prostate cancer. Explore patients' willingness to share health data for developing clinical AI. Assess healthcare providers' acceptability of AI in this diagnostic context. Methodology Design: A cross-sectional, mixed-method, multinational study (Belgium, Italy, Spain). Quantitative Phase: Online questionnaire, using adapted theoretical frameworks (Value Perception Model, NASSS-AI, TFA). Qualitative Phase: Will follow based on quantitative findings. Participants: Adults diagnosed with localized prostate cancer. Recruitment via hospitals, social media, and patient associations. Data Collected: Personal and health information, attitudes toward AI, willingness to share data. Ethics Approved by ethics committees in each participating country. Informed consent obtained digitally before participation. Data anonymized and GDPR-compliant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable prostate-cancer

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

December 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

June 10, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

QuestionnaireArtificial IntelligenceAcceptability of AI

Outcome Measures

Primary Outcomes (4)

  • Perceived Benefits of using AI in the diagnosis of prostate cancer

    They are latent measures and will be assessed in several questions: * Benefits: I believe that tools based on artificial intelligence can 'Improve the diagnosis of prostate cancer', 'Advance the prostate cancer diagnostic process', 'Provide an accurate diagnosis of prostate cancer', Reduce the costs of prostate cancer diagnosis'. Scale: "Strongly disagree", "Disagree", "Somewhat disagree", "Neither agree nor disagree", "Somewhat agree", "Agree", "Strongly agree"; 'Strongly agree' gives the highest value of benefit.

    Baseline

  • Perceived Risks of using AI in the prostate cancer diagnosis

    Risks, scale "Very low", "Low", "Somewhat low", "Moderate", "Somewhat high", "High", "Very high". The questions are too long to include here but they access the percieved risks of using AI in the diagnosis and treatment of prostate cancer. The 'very high' risk is considered the worst.

    Baseline

  • Intention to use AI

    Question: Would you like to use artificial intelligence-based tools to manage my prostate cancer diagnosis. Answers - yes, uncertain beacause and no; then there are concerns if they answer 'no' or 'yes because' and they evaluate these concerns on the scale from 0 to 10; 10 is the biggest concern.

    Baseline

  • Willingless to share personal data

    Question: Willingless to share personal data; answers 'yes', 'no', yes with conditions; then they can describe their conditions

    Baseline

Study Arms (1)

Questionnaire

EXPERIMENTAL

This is an online questionnaire that the patients copmlete on their own or with the help of the responsable person

Other: Questionnaire and Physical Exam

Interventions

This is an online questionnaire that the patients fill in

Questionnaire

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years;
  • with diagnose of localized prostate cancer;
  • consent to the study.

You may not qualify if:

  • not speaking French;
  • diagnosed with metastatic cancer from the outset;
  • terminally ill;
  • people suffering from mental retardation, dementia or altered state of consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Liege

Liège, Belgium

Location

Related Publications (3)

  • Frost EK, Bosward R, Aquino YSJ, Braunack-Mayer A, Carter SM. Facilitating public involvement in research about healthcare AI: A scoping review of empirical methods. Int J Med Inform. 2024 Jun;186:105417. doi: 10.1016/j.ijmedinf.2024.105417. Epub 2024 Mar 22.

  • Esmaeilzadeh P. Use of AI-based tools for healthcare purposes: a survey study from consumers' perspectives. BMC Med Inform Decis Mak. 2020 Jul 22;20(1):170. doi: 10.1186/s12911-020-01191-1.

  • Fazakarley CA, Breen M, Thompson B, Leeson P, Williamson V. Beliefs, experiences and concerns of using artificial intelligence in healthcare: A qualitative synthesis. Digit Health. 2024 Feb 11;10:20552076241230075. doi: 10.1177/20552076241230075. eCollection 2024 Jan-Dec.

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientifique R&D

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 20, 2025

Study Start

December 2, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations