Prostate CancerNCT07040501
Improving Patient Understanding of Their Prostate Cancer Diagnosis Using AI
A study testing Chat GPT in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Chat GPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who do not meet the inclusion criteria, as stated above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Case Comprehensive Cancer Center, Cleveland Clinic Glickman Urologic Institute
Cleveland, Ohio, 44195
Zeyad Schwen, MD
About this study
Official title: Can Artificial Intelligence Help Improve Patient Understanding of Their Diagnosis? Using ChatGPT as an Interactive Chatbot for Patients With Localized Prostate Cancer, a Feasibility Study
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.
Read the detailed description
Prostate cancer is the second most common cancer among men and poses a significant challenge due to its varied clinical course, ranging from indolent tumors that only requires surveillance, to aggressive life-threatening metastatic disease.1 Nearly 1 million prostate biopsies are performed in the United States each year, and approximately 25% of these biopsies result in a prostate cancer diagnosis. One out every four patients receiving a prostate biopsy will inevitably have a positive pathology report, and are typically waiting anywhere from 2 days to multiple weeks prior to follow-up with their healthcare provider. It is without question that patients experience substantial anxiety while awaiting pathology results or making treatment decisions, as the uncertainty surrounding their diagnosis can be overwhelming.
Risk stratification in localized prostate cancer requires the patient's pre-biopsy PSA (prostate-specific antigen) value and prostate biopsy results. Once appropriately risk-stratified, depending on their risk level, patients may require additional staging scans, followed by a discussion with their urologist or oncologist regarding treatment options. Treatment options for localized prostate cancer may include active surveillance, radical prostatectomy, radiotherapy, or focal therapy.
Chat GPT, developed by Open AI, is a large language model based on the GPT (Generative Pre-trained Transformer) architecture. It leverages deep learning techniques, specifically transformer networks, to generate human-like text responses. Trained on vast amounts of diverse data, it uses pattern recognition and contextual understanding to engage in meaningful conversations. Initially aimed at general natural language processing tasks, Chat GPT's capabilities have been adapted for various applications, including healthcare, where it can assist in patient communication, decision support, and educational initiatives. A recent study has shown promising results with several large language model chatbots such as Chat GPT, which was able to simplify pathology reports for the average layperson with 97% accuracy, and an extremely low rate of hallucination (0.26%).2 Technology such as this could empower patients to not only better understand their disease, but disease but also increase participation in shared decision-making. In addition, to test how well AI-powered chatbots perform, when asked some of the most queried questions about the five most common cancers, including prostate cancer, a recent study in JAMA oncology reported that the quality of information generated by four different AI chatbots were good (median DISCERN score of 5, indicating high quality of information), and no misinformation was identified.3
In the current era, where information is so readily available and accessible, patients are often able to 'Google' their own diagnosis before seeing the clinician for follow-up. However, there is no quality-control for the information that is presented online. Often, when patients input keywords such as 'prostate cancer' into search engines, they are led down a rabbit-hole of information, that is neither accurate, nor easy to understand. Loeb et al, performed a comprehensive overview of available prostate cancer videos on screening and treatment on the You tube platform, and deemed the quality of information as only moderate, with 77% of videos containing potentially misinformative or biased content, and there was a significant negative correlation between scientific quality and viewer engagement (viewer reviews via thumbs up, and number of views).4 An additional study which examined the readability of prostate cancer information online found that the large majority of information available on the Internet about prostate cancer are difficult to understand, particularly for older adults - who may already have compromised capacity to understand health information, who happens to also be the population at greatest risk for prostate cancer.5 Another study showed that when prompted, the free version of Chat GPT was able to paraphrase health information to a grade six reading level, which is associated with increased readability for the general public.6 Given the challenges of locating reliable, and patient-friendly information online regarding a new prostate cancer diagnosis, investigator identified a potential gap that may be filled by AI-powered chatbots.
Although high-quality patient-oriented websites (such as the Cleveland Clinic or Mayo Clinic websites) do exist, along with other sources of vetted patient education materials (such as the Cancer Support Community, and Facing Our Risk of Cancer Empowered - FORCE), these are often not what patients turn to at first, especially given the influence of social media platforms and news outlets.
Our proposed Prostate Cancer chatbot is not meant to replace these vetted resources, but to enhance patient comprehension in addition to what is available, by having information presented in a different format - interactive and customized. In fact, in a recent white paper published by the ACCC (Association of Community Cancer Centers), one listed future goal of patient-centered reporting of pathology results, is to include interactive web pages with customized educational content - which is exactly what our chatbot hopes to achieve.7 The main goal of this project is to create a tool which can enhance understanding of pathology reports, which is filled with medical terminology and grading systems.
- Conditions
- Prostate Cancer
- Being tested
- Chat GPT
- Keywords
- Chat GPT, AI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Chat GPT - Prostate Pathology Guide | Experimental | Not described Receives: Device: Chat GPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy as assessed by the rate of correctly identified and risk-stratified participants diagnosed with prostate cancer
Measured: Post intervention(approximately 70 minutes)
Secondary outcomes (3)
Patient anxiety as measured by Visual analog scale(VAS-A)
VAS-A: Answers rated on scale of 0 to 100 - where 0 is not at all anxious and 100 is extremely anxious
Measured: Baseline and post intervention(approximately 70 minutes)
Understandability of diagnosis as measured by EORTC QLQ-INFO25
EORTC QLQ-INFO25: Answers rated on scale of 1 to 4 - not at all, a little, quite a bit, very much
Measured: Baseline and post intervention(approximately 70 minutes)
Understandability of Chat GPT as assessed by Patient Education Materials Assessment Tool(PEMAT)
This will be measured by three evaluators who will complete the PEMAT (patient education materials assessment tool) using chatlogs from different patient encounters. The questionnaire has twenty-six items, and will ask for responses on a two point scale of "Disagree" meaning 0 points, and "Agree" meaning 1 point. Higher scores mean a better outcome.
Measured: Post intervention(approximately 70 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeyad Schwen, MD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic Glickman Urologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040501
- Sponsor's protocol ID
- CASE14824
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Artificial Intelligence Help Improve Patient Understanding of Their Diagnosis? Using ChatGPT as an Interactive Chatbot for Patients With Localized Prostate Cancer, a Feasibility Study
- ClinicalTrials.gov ID
- NCT07040501
- Acronym / sponsor ID
- CASE14824
- Conditions
- Prostate Cancer
- Keywords
- Chat GPT, AI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate cancer is the second most common cancer among men and poses a significant challenge due to its varied clinical course, ranging from indolent tumors that only requires surveillance, to aggressive life-threatening metastatic disease.1 Nearly 1 million prostate biopsies are performed in the United States each year, and approximately 25% of these biopsies result in a prostate cancer diagnosis. One out every four patients receiving a prostate biopsy will inevitably have a positive pathology report, and are typically waiting anywhere from 2 days to multiple weeks prior to follow-up with their healthcare provider. It is without question that patients experience substantial anxiety while awaiting pathology results or making treatment decisions, as the uncertainty surrounding their diagnosis can be overwhelming.
Risk stratification in localized prostate cancer requires the patient's pre-biopsy PSA (prostate-specific antigen) value and prostate biopsy results. Once appropriately risk-stratified, depending on their risk level, patients may require additional staging scans, followed by a discussion with their urologist or oncologist regarding treatment options. Treatment options for localized prostate cancer may include active surveillance, radical prostatectomy, radiotherapy, or focal therapy.
Chat GPT, developed by Open AI, is a large language model based on the GPT (Generative Pre-trained Transformer) architecture. It leverages deep learning techniques, specifically transformer networks, to generate human-like text responses. Trained on vast amounts of diverse data, it uses pattern recognition and contextual understanding to engage in meaningful conversations. Initially aimed at general natural language processing tasks, Chat GPT's capabilities have been adapted for various applications, including healthcare, where it can assist in patient communication, decision support, and educational initiatives. A recent study has shown promising results with several large language model chatbots such as Chat GPT, which was able to simplify pathology reports for the average layperson with 97% accuracy, and an extremely low rate of hallucination (0.26%).2 Technology such as this could empower patients to not only better understand their disease, but disease but also increase participation in shared decision-making. In addition, to test how well AI-powered chatbots perform, when asked some of the most queried questions about the five most common cancers, including prostate cancer, a recent study in JAMA oncology reported that the quality of information generated by four different AI chatbots were good (median DISCERN score of 5, indicating high quality of information), and no misinformation was identified.3
In the current era, where information is so readily available and accessible, patients are often able to 'Google' their own diagnosis before seeing the clinician for follow-up. However, there is no quality-control for the information that is presented online. Often, when patients input keywords such as 'prostate cancer' into search engines, they are led down a rabbit-hole of information, that is neither accurate, nor easy to understand. Loeb et al, performed a comprehensive overview of available prostate cancer videos on screening and treatment on the You tube platform, and deemed the quality of information as only moderate, with 77% of videos containing potentially misinformative or biased content, and there was a significant negative correlation between scientific quality and viewer engagement (viewer reviews via thumbs up, and number of views).4 An additional study which examined the readability of prostate cancer information online found that the large majority of information available on the Internet about prostate cancer are difficult to understand, particularly for older adults - who may already have compromised capacity to understand health information, who happens to also be the population at greatest risk for prostate cancer.5 Another study showed that when prompted, the free version of Chat GPT was able to paraphrase health information to a grade six reading level, which is associated with increased readability for the general public.6 Given the challenges of locating reliable, and patient-friendly information online regarding a new prostate cancer diagnosis, investigator identified a potential gap that may be filled by AI-powered chatbots.
Although high-quality patient-oriented websites (such as the Cleveland Clinic or Mayo Clinic websites) do exist, along with other sources of vetted patient education materials (such as the Cancer Support Community, and Facing Our Risk of Cancer Empowered - FORCE), these are often not what patients turn to at first, especially given the influence of social media platforms and news outlets.
Our proposed Prostate Cancer chatbot is not meant to replace these vetted resources, but to enhance patient comprehension in addition to what is available, by having information presented in a different format - interactive and customized. In fact, in a recent white paper published by the ACCC (Association of Community Cancer Centers), one listed future goal of patient-centered reporting of pathology results, is to include interactive web pages with customized educational content - which is exactly what our chatbot hopes to achieve.7 The main goal of this project is to create a tool which can enhance understanding of pathology reports, which is filled with medical terminology and grading systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chat GPT - Prostate Pathology Guide | Experimental | Device: Chat GPT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who do not meet the inclusion criteria, as stated above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chat GPTOn 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. | Device | Chat GPT - Prostate Pathology Guide |
Primary outcome
Accuracy as assessed by the rate of correctly identified and risk-stratified participants diagnosed with prostate cancer
Time frame: Post intervention(approximately 70 minutes)
3 secondary outcomes
Patient anxiety as measured by Visual analog scale(VAS-A)
Time frame: Baseline and post intervention(approximately 70 minutes)
Understandability of diagnosis as measured by EORTC QLQ-INFO25
Time frame: Baseline and post intervention(approximately 70 minutes)
Understandability of Chat GPT as assessed by Patient Education Materials Assessment Tool(PEMAT)
Time frame: Post intervention(approximately 70 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeyad Schwen, MD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic Glickman Urologic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chat GPT in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeyad Schwen, MD (216-444-2200, schwenz2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy as assessed by the rate of correctly identified and risk-stratified participants diagnosed with prostate cancer (time frame: Post intervention(approximately 70 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.