Metastatic Prostate CancerLUMINOUSNCT07804030
AI-Assisted Patient Support in mHSPC
A study testing The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support and Delayed AI Agent-Assisted Patient-Centered Support in people with Metastatic Prostate Cancer, run by Fudan University at 4 sites in China.
Trial summary
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support and Delayed AI Agent-Assisted Patient-Centered Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2026to Mar 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology;
- Metastatic disease confirmed by imaging or pathology;
- Diagnosis of metastatic prostate cancer within 2 weeks before enrollment;
- Aged 18-80 years;
- A GAD-7 score of 5 or higher at screening;
- Adequate cognitive ability to understand and participate in the study;
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- Adequate language comprehension and ability to complete the study questionnaires independently;
- Access to a smartphone and an internet connection required to use the study platform;
- Provision of written informed consent.
Who cannot join
- An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care;
- History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease;
- A requirement for emergency surgery within 72 hours after enrollment;
- Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period;
- Current participation in another interventional clinical trial;
- A request from the participant's family to withhold the diagnosis or disease-related information from the participant.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Fujian Cancer Hospital
Fuzhou, Fujian, 350011
Shushang Chen, MD, +86 15859198855, 121257401@qq.com
Yunnan Cancer Hospital
Kunming, Yunnan
Yong Yang, +86-0871 68185656, yongy1974@163.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dai Bo, MD, +86-21 64175590, bodai1978@126.com
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wei Chen, MD, +86 15000238255, 2818777033@qq.com
About this study
Official title: Effects of Large LangUage Model-Based AI Agent-Assisted Patient-Centered Support on ANxiety, Illness PerceptiOn, and Sleep QUality in Patients With Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Participants access the AI agent through a WeChat Mini Program-based platform. The study will also assess the effects of this intervention on illness perception, sleep quality, and patient satisfaction. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will have access to the AI agent-enabled patient support platform throughout the 4-week study period. Participants in the control group will use the same platform without access to the AI agent during the first 2 weeks and will then receive access to the AI agent for the subsequent 2 weeks. Both groups will receive standard-of-care medical treatment throughout the study. The primary objective is to compare changes from baseline in anxiety at 2 weeks between the two groups. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Secondary outcomes include illness perception, sleep quality, and patient satisfaction. Exploratory outcomes include the change from baseline in the GAD-7 total score at 4 weeks and the accuracy of responses generated by the AI agent to participants' questions.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support, Delayed AI Agent-Assisted Patient-Centered Support, Standard-of-Care Medical Treatment
- Keywords
- Prostate cancer, Large Language Model, Anxiety, Illness Perception, Patient Satisfaction
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Same Platform without AI AgentBehavioural
The basic platform supports study registration, assessments, and usage tracking but does not provide AI agent function during the first 2 weeks.
AI Agent-Assisted Patient-Centered SupportBehavioural
Participants access the AI agent through a WeChat Mini Program. It provides clinician-reviewed educational materials on prostate cancer and disease management. A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions. Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses. The AI agent will not replace physician assessment, diagnosis, or treatment decision-making.
Delayed AI Agent-Assisted Patient-Centered SupportBehavioural
Participants will receive access of AI agent after completing the 2-week assessments. The AI agent is accessible through a WeChat Mini Program. It provides clinician-reviewed educational materials on prostate cancer and disease management. A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions. Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses. The AI agent will not replace physician assessment, diagnosis, or treatment decision-making.
Standard-of-Care Medical TreatmentDrug
Participants will continue to receive standard-of-care medical treatment for mHSPC throughout the study. Treatment may include androgen deprivation therapy (ADT) in combination with an androgen receptor pathway inhibitor (ARPi), and bone-protective agents may also be administered, as determined by the treating physician according to clinical guidelines and individual patient needs. However, radiotherapy, surgery, or chemotherapy in any form is not permitted during the study period. Non-antineoplastic medications taken prior to enrollment may be continued during the study.
| Study group | Role | What they receive |
|---|---|---|
| Immediate AI Agent Access | Experimental | Participants will receive immediate access to the AI Agent for 4 weeks after randomization, in addition to standard-of-care medical treatment. Receives: Behavioral: AI Agent-Assisted Patient-Centered Support; Drug: Standard-of-Care Medical Treatment |
| Delayed AI Agent Access | Active comparator | Participants will use the same platform without access to the AI agent during the first 2 weeks after randomization, in addition to standard-of-care medical treatment. After completing the 2-week assessments, participants will receive access to the AI agent for the remaining 2 weeks. Receives: Behavioral: The Same Platform without AI Agent; Behavioral: Delayed AI Agent-Assisted Patient-Centered Support; Drug: Standard-of-Care Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) scale assesses anxiety symptoms using 7 items, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity. Change from baseline is calculated as the score at 2 weeks minus the baseline score, with a negative change indicating improvement. The mean change from baseline will be compared between the two groups.
Measured: At baseline and 2 weeks after randomization.
Secondary outcomes (4)
Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
The study-specific Disease Knowledge Test consists of 10 objective questions on mHSPC. Each correct answer is scored as 1, and each incorrect or unknown answer is scored as 0. The total score ranges from 0 to 10, with higher scores indicating greater disease knowledge. The mean total score at 2 weeks will be compared between the two groups.
Measured: At 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks
The Brief Illness Perception Questionnaire (B-IPQ) assesses cognitive and emotional representations of illness. Eight scored items are rated from 0 to 10. After appropriate reverse scoring, the total score ranges from 0 to 80, with higher scores indicating a more threatening perception of the illness. Change from baseline is calculated as the score at 2 weeks minus the baseline score, with negative values indicating improvement. The mean change from baseline will be compared between the two groups.
Measured: At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks
The Insomnia Severity Index (ISI) assesses insomnia severity using 7 items, each scored from 0 to 4. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. Change from baseline is calculated as the score at 2 weeks minus the baseline score, with negative values indicating improvement. The mean change from baseline will be compared between the two groups.
Measured: At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks
The Patient Satisfaction Questionnaire-18 (PSQ-18) consists of 18 items assessing satisfaction with medical care across seven domains. Each item is scored from 1 to 5. After appropriate reverse scoring, the item scores are summed to produce a total score ranging from 18 to 90, with higher scores indicating greater patient satisfaction. Change from baseline is calculated as the score at 2 weeks minus the baseline score, with positive values indicating improvement. The mean change from baseline will be compared between the two groups.
Measured: At baseline and 2 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Dai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804030
- Sponsor's protocol ID
- PCaAICom-01
- Acronym
- LUMINOUS
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Large LangUage Model-Based AI Agent-Assisted Patient-Centered Support on ANxiety, Illness PerceptiOn, and Sleep QUality in Patients With Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07804030
- Acronym / sponsor ID
- LUMINOUS / PCaAICom-01
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate cancer, Large Language Model, Anxiety, Illness Perception, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Sep 2026 (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 multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Participants access the AI agent through a WeChat Mini Program-based platform. The study will also assess the effects of this intervention on illness perception, sleep quality, and patient satisfaction. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will have access to the AI agent-enabled patient support platform throughout the 4-week study period. Participants in the control group will use the same platform without access to the AI agent during the first 2 weeks and will then receive access to the AI agent for the subsequent 2 weeks. Both groups will receive standard-of-care medical treatment throughout the study. The primary objective is to compare changes from baseline in anxiety at 2 weeks between the two groups. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Secondary outcomes include illness perception, sleep quality, and patient satisfaction. Exploratory outcomes include the change from baseline in the GAD-7 total score at 4 weeks and the accuracy of responses generated by the AI agent to participants' questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate AI Agent Access | Experimental | Behavioral: AI Agent-Assisted Patient-Centered Support, Drug: Standard-of-Care Medical TreatmentParticipants will receive immediate access to the AI Agent for 4 weeks after randomization, in addition to standard-of-care medical treatment. |
| Delayed AI Agent Access | Active comparator | Behavioral: The Same Platform without AI Agent, Behavioral: Delayed AI Agent-Assisted Patient-Centered Support, Drug: Standard-of-Care Medical TreatmentParticipants will use the same platform without access to the AI agent during the first 2 weeks after randomization, in addition to standard-of-care medical treatment. After completing the 2-week assessments, participants will receive access to the AI agent for the remaining 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology;
- Metastatic disease confirmed by imaging or pathology;
- Diagnosis of metastatic prostate cancer within 2 weeks before enrollment;
- Aged 18-80 years;
- A GAD-7 score of 5 or higher at screening;
Key exclusion criteria (6 listed)
- An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care;
- History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease;
- A requirement for emergency surgery within 72 hours after enrollment;
- Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period;
- Current participation in another interventional clinical trial;
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 |
|---|---|---|
| The Same Platform without AI AgentThe basic platform supports study registration, assessments, and usage tracking but does not provide AI agent function during the first 2 weeks. | Behavioural | Delayed AI Agent Access |
| AI Agent-Assisted Patient-Centered SupportParticipants access the AI agent through a WeChat Mini Program. It provides clinician-reviewed educational materials on prostate cancer and disease management. A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions. Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses. The AI agent will not replace physician assessment, diagnosis, or treatment decision-making. | Behavioural | Immediate AI Agent Access |
| Delayed AI Agent-Assisted Patient-Centered SupportParticipants will receive access of AI agent after completing the 2-week assessments. The AI agent is accessible through a WeChat Mini Program. It provides clinician-reviewed educational materials on prostate cancer and disease management. A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions. Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses. The AI agent will not replace physician assessment, diagnosis, or treatment decision-making. | Behavioural | Delayed AI Agent Access |
| Standard-of-Care Medical TreatmentParticipants will continue to receive standard-of-care medical treatment for mHSPC throughout the study. Treatment may include androgen deprivation therapy (ADT) in combination with an androgen receptor pathway inhibitor (ARPi), and bone-protective agents may also be administered, as determined by the treating physician according to clinical guidelines and individual patient needs. However, radiotherapy, surgery, or chemotherapy in any form is not permitted during the study period. Non-antineoplastic medications taken prior to enrollment may be continued during the study. | Drug | Delayed AI Agent Access, Immediate AI Agent Access |
Primary outcome
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks
Time frame: At baseline and 2 weeks after randomization.
The Generalized Anxiety Disorder-7 (GAD-7) scale assesses anxiety symptoms using 7 items, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity. Change from baseline is calculated as the score at 2 weeks minus the baseline score, with a negative change indicating improvement. The mean change from baseline will be compared between the two groups.
4 secondary outcomes
Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
Time frame: At 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks
Time frame: At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks
Time frame: At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks
Time frame: At baseline and 2 weeks after randomization.
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support and Delayed AI Agent-Assisted Patient-Centered Support in people with Metastatic Prostate Cancer, run by Fudan University at 4 sites in China.
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 9 inclusion and 6 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 Bo Dai, MD (+86-21 64175590, bodai1978@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks (time frame: At baseline and 2 weeks after randomization.). 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 4 Sep 2026.