NCT07040501

Brief Summary

The purpose of this study is to determine if ChatGPT (an artificial intelligence driven chatbot) can help patients better understand their own pathology results and prostate cancer diagnosis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 6, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

June 6, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

Chat GPTAI

Outcome Measures

Primary Outcomes (1)

  • Accuracy as assessed by the rate of correctly identified and risk-stratified participants diagnosed with prostate cancer

    Post intervention(approximately 70 minutes)

Secondary Outcomes (3)

  • Patient anxiety as measured by Visual analog scale(VAS-A)

    Baseline and post intervention(approximately 70 minutes)

  • Understandability of diagnosis as measured by EORTC QLQ-INFO25

    Baseline and post intervention(approximately 70 minutes)

  • Understandability of Chat GPT as assessed by Patient Education Materials Assessment Tool(PEMAT)

    Post intervention(approximately 70 minutes)

Study Arms (1)

Chat GPT - Prostate Pathology Guide

EXPERIMENTAL
Device: Chat GPT

Interventions

Chat GPTDEVICE

On the date of appointment, participants will be given up to 30 minutes, to interact with a pre-prompted Chat GPT (Prostate Pathology Guide) using a Cleveland clinic device.

Chat GPT - Prostate Pathology Guide

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be \>18 years or age
  • Participants must have received a prostate biopsy at Cleveland Clinic main campus within the last 30 days, and have not received follow-up on their pathology results
  • Participants must be willing to attend an in-person follow-up to review their pathology
  • Participants must be English speaking
  • Participants must provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Glickman Urologic Institute

Cleveland, Ohio, 44195, 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

  • Zeyad Schwen, MD

    Case Comprehensive Cancer Center, Cleveland Clinic Glickman Urologic Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeyad Schwen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 27, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations