Prostate CancerNCT07924644
AI-Based Digital Pathology Model for Predicting Treatment Response and Prognosis in mHSPC
A study testing Artificial Intelligence-Based Digital Pathology Assessment in people with Prostate Cancer and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this multicenter observational study is to develop and validate an artificial intelligence-based digital pathology model to predict treatment response and prognosis in adult men with metastatic hormone-sensitive prostate cancer treated with androgen deprivation therapy plus androgen receptor signaling… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer)
- What is being tested?
- Artificial Intelligence-Based Digital Pathology Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,115 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate adenocarcinoma diagnosed as metastatic hormone-sensitive prostate cancer at initial diagnosis. Metastatic disease may include distant bone metastases, visceral metastases, and/or metastatic lymph node involvement according to the definition of metastatic hormone-sensitive prostate cancer at the time of diagnosis.
- Received first-line systemic therapy consisting of standard androgen deprivation therapy, either surgical or medical castration, in combination with at least one androgen receptor signaling inhibitor, including but not limited to abiraterone plus prednisone, enzalutamide, or apalutamide.
- Availability of diagnostic prostate needle biopsy specimens obtained at initial diagnosis, with formalin-fixed paraffin-embedded tissue sections available and digitized into high-resolution whole-slide images in .svs format.
- Availability of complete clinical follow-up data, including serial prostate-specific antigen measurements after treatment, recorded monthly or quarterly when available, and documented information on progression to metastatic castration-resistant prostate cancer. In particular, prostate-specific antigen level at approximately 6 to 7 months after treatment initiation must be available.
- Age 18 years or older at the time of diagnosis or treatment initiation.
- Eastern Cooperative Oncology Group performance status of 0 to 2 at the time of first-line systemic treatment initiation.
- Expected survival of more than 6 months at the time of first-line systemic treatment initiation.
- Informed consent or ethical approval for research use of clinical data and pathology materials must have been obtained according to the requirements of each participating center.
Who cannot join
- Unavailable or unusable pathology slide images, including missing tissue blocks or slides, failure of slide digitization, or whole-slide images of insufficient quality for artificial intelligence analysis.
- Pathology specimens obtained from surgical resection rather than diagnostic needle biopsy. To ensure consistency of tissue source, only prostate needle biopsy specimens obtained at initial diagnosis will be included.
- Diagnosis of special histological subtypes or mixed malignancies that do not represent typical androgen receptor pathway-driven prostate adenocarcinoma, including cases with a prominent small-cell neuroendocrine carcinoma component.
- Discontinuation of first-line androgen deprivation therapy plus androgen receptor signaling inhibitor within 6 months for reasons unrelated to disease progression, such as severe adverse events, intolerance, or patient refusal.
- Incomplete follow-up information, including inability to determine the date of progression to metastatic castration-resistant prostate cancer or lack of adequate follow-up data for outcome assessment.
- -Receipt of additional systemic therapies that may substantially affect prostate-specific antigen levels during the treatment course, such as poly adenosine diphosphate-ribose polymerase inhibitors, unless such therapies were initiated after the defined outcome assessment period or after progression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study on the Development and Validation of an Artificial Intelligence-Based Digital Pathology Model for Predicting Treatment Response and Prognosis in Patients With Metastatic Hormone-Sensitive Prostate Cancer
The goal of this multicenter observational study is to develop and validate an artificial intelligence-based digital pathology model to predict treatment response and prognosis in adult men with metastatic hormone-sensitive prostate cancer treated with androgen deprivation therapy plus androgen receptor signaling inhibitors.
The main questions it aims to answer are:
Read more
Can digital pathology-based artificial intelligence predict deep prostate-specific antigen response, defined as prostate-specific antigen less than 0.2 ng/mL at 6 to 7 months after treatment? Can digital pathology-based artificial intelligence predict progression to metastatic castration-resistant prostate cancer and time to metastatic castration-resistant prostate cancer? Researchers will compare artificial intelligence-defined low-risk and high-risk groups to evaluate whether the model can improve prediction of treatment response and prognosis beyond conventional clinicopathological risk stratification.
Participants will not receive any additional intervention as part of this study. Researchers will retrospectively collect clinical characteristics, treatment records, prostate-specific antigen response data, follow-up outcomes, and archived prostate biopsy slides from participating centers. The biopsy slides will be scanned into whole-slide images and analyzed using artificial intelligence to develop and validate predictive models.
- Being tested
- Artificial Intelligence-Based Digital Pathology Assessment
- Keywords
- Prostate cancer, ARSI, mCRPC, WSI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Based Digital Pathology AssessmentOther
Archived prostate biopsy pathology slides will be digitized as whole-slide images and analyzed using an artificial intelligence-based digital pathology model. The model will be developed and validated to predict treatment response and prognosis in patients with metastatic hormone-sensitive prostate cancer treated with androgen deprivation therapy plus androgen receptor signaling inhibitors. No study-mandated treatment intervention will be assigned, and the artificial intelligence results will not be used to guide clinical treatment decisions during this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Patients With mHSPC | Other | Adult men diagnosed with metastatic hormone-sensitive prostate cancer and treated with androgen deprivation therapy combined with androgen receptor signaling inhibitors. Clinical data, treatment response, follow-up outcomes, and archived prostate biopsy whole-slide images will be collected for artificial intelligence model development and validation. Receives: Other: Artificial Intelligence-Based Digital Pathology Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Performance of the AI-Based Digital Pathology Model for Deep PSA Response
The primary outcome measure is the area under the receiver operating characteristic curve of the artificial intelligence-based digital pathology model for predicting deep prostate-specific antigen response. Deep PSA response is defined as a prostate-specific antigen level of less than 0.2 ng/mL at 6 to 7 months after initiation of androgen deprivation therapy plus androgen receptor signaling inhibitors. Model performance will be evaluated in the validation cohort.
Measured: 6 to 7 months after initiation of ADT plus ARSI
Secondary outcomes (1)
Concordance Index of the Artificial Intelligence-Based Digital Pathology Model for Predicting Metastatic Castration-Resistant Prostate Cancer
The secondary outcome measure is the concordance index of the artificial intelligence-based digital pathology model for predicting time to metastatic castration-resistant prostate cancer. Time to metastatic castration-resistant prostate cancer is defined as the interval from initiation of androgen deprivation therapy plus androgen receptor signaling inhibitors to the development of metastatic castration-resistant prostate cancer. Patients without metastatic castration-resistant prostate cancer at the last follow-up will be censored. Model performance will be evaluated in the validation cohort.
Measured: Up to 60 months after initiation of androgen deprivation therapy plus androgen receptor signaling inhibitors.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Jan 2019
- Primary completion31 Mar 2026
- Study completion31 Dec 2026 (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 Xiangya Hospital of Central South 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924644
- Sponsor's protocol ID
- 2026010083_3
- Status last verified
- May 2026
- First submitted
- 1 Jul 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because this study involves multicenter clinical data, pathology whole-slide images, and follow-up information from patients with metastatic hormone-sensitive prostate cancer. Although data will be de-identified, the combination of clinical variables and pathology images may still carry potential privacy and re-identification risks. Data sharing is also subject to the ethical approvals, institutional policies, and data use agreements of each participating center. Reasonable requests for access to aggregated or de-identified data may be considered by the principal investigator, subject to approval by the relevant ethics committees and participating institutions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Development and Validation of an Artificial Intelligence-Based Digital Pathology Model for Predicting Treatment Response and Prognosis in Patients With Metastatic Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07924644
- Acronym / sponsor ID
- 2026010083_3
- Keywords
- Prostate cancer, ARSI, mCRPC, WSI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,115 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Nov 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 goal of this multicenter observational study is to develop and validate an artificial intelligence-based digital pathology model to predict treatment response and prognosis in adult men with metastatic hormone-sensitive prostate cancer treated with androgen deprivation therapy plus androgen receptor signaling inhibitors.
The main questions it aims to answer are:
Can digital pathology-based artificial intelligence predict deep prostate-specific antigen response, defined as prostate-specific antigen less than 0.2 ng/mL at 6 to 7 months after treatment? Can digital pathology-based artificial intelligence predict progression to metastatic castration-resistant prostate cancer and time to metastatic castration-resistant prostate cancer? Researchers will compare artificial intelligence-defined low-risk and high-risk groups to evaluate whether the model can improve prediction of treatment response and prognosis beyond conventional clinicopathological risk stratification.
Participants will not receive any additional intervention as part of this study. Researchers will retrospectively collect clinical characteristics, treatment records, prostate-specific antigen response data, follow-up outcomes, and archived prostate biopsy slides from participating centers. The biopsy slides will be scanned into whole-slide images and analyzed using artificial intelligence to develop and validate predictive models.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With mHSPC | Other | Other: Artificial Intelligence-Based Digital Pathology AssessmentAdult men diagnosed with metastatic hormone-sensitive prostate cancer and treated with androgen deprivation therapy combined with androgen receptor signaling inhibitors. Clinical data, treatment response, follow-up outcomes, and archived prostate biopsy whole-slide images will be collected for artificial intelligence model development and validation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed prostate adenocarcinoma diagnosed as metastatic hormone-sensitive prostate cancer at initial diagnosis. Metastatic disease may include distant bone metastases, visceral metastases, and/or metastatic lymph node involvement according to the definition of metastatic hormone-sensitive prostate cancer at the time of diagnosis.
- Received first-line systemic therapy consisting of standard androgen deprivation therapy, either surgical or medical castration, in combination with at least one androgen receptor signaling inhibitor, including but not limited to abiraterone plus prednisone, enzalutamide, or apalutamide.
- Availability of diagnostic prostate needle biopsy specimens obtained at initial diagnosis, with formalin-fixed paraffin-embedded tissue sections available and digitized into high-resolution whole-slide images in .svs format.
- Availability of complete clinical follow-up data, including serial prostate-specific antigen measurements after treatment, recorded monthly or quarterly when available, and documented information on progression to metastatic castration-resistant prostate cancer. In particular, prostate-specific antigen level at approximately 6 to 7 months after treatment initiation must be available.
- Age 18 years or older at the time of diagnosis or treatment initiation.
Key exclusion criteria (6 listed)
- Unavailable or unusable pathology slide images, including missing tissue blocks or slides, failure of slide digitization, or whole-slide images of insufficient quality for artificial intelligence analysis.
- Pathology specimens obtained from surgical resection rather than diagnostic needle biopsy. To ensure consistency of tissue source, only prostate needle biopsy specimens obtained at initial diagnosis will be included.
- Diagnosis of special histological subtypes or mixed malignancies that do not represent typical androgen receptor pathway-driven prostate adenocarcinoma, including cases with a prominent small-cell neuroendocrine carcinoma component.
- Discontinuation of first-line androgen deprivation therapy plus androgen receptor signaling inhibitor within 6 months for reasons unrelated to disease progression, such as severe adverse events, intolerance, or patient refusal.
- Incomplete follow-up information, including inability to determine the date of progression to metastatic castration-resistant prostate cancer or lack of adequate follow-up data for outcome assessment.
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 |
|---|---|---|
| Artificial Intelligence-Based Digital Pathology AssessmentArchived prostate biopsy pathology slides will be digitized as whole-slide images and analyzed using an artificial intelligence-based digital pathology model. The model will be developed and validated to predict treatment response and prognosis in patients with metastatic hormone-sensitive prostate cancer treated with androgen deprivation therapy plus androgen receptor signaling inhibitors. No study-mandated treatment intervention will be assigned, and the artificial intelligence results will not be used to guide clinical treatment decisions during this observational study. | Other | Patients With mHSPC |
Primary outcome
Predictive Performance of the AI-Based Digital Pathology Model for Deep PSA Response
Time frame: 6 to 7 months after initiation of ADT plus ARSI
The primary outcome measure is the area under the receiver operating characteristic curve of the artificial intelligence-based digital pathology model for predicting deep prostate-specific antigen response. Deep PSA response is defined as a prostate-specific antigen level of less than 0.2 ng/mL at 6 to 7 months after initiation of androgen deprivation therapy plus androgen receptor signaling inhibitors. Model performance will be evaluated in the validation cohort.
1 secondary outcome
Concordance Index of the Artificial Intelligence-Based Digital Pathology Model for Predicting Metastatic Castration-Resistant Prostate Cancer
Time frame: Up to 60 months after initiation of androgen deprivation therapy plus androgen receptor signaling inhibitors.
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 9 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because this study involves multicenter clinical data, pathology whole-slide images, and follow-up information from patients with metastatic hormone-sensitive prostate cancer. Although data will be de-identified, the combination of clinical variables and pathology images may still carry potential privacy and re-identification risks. Data sharing is also subject to the ethical approvals, institutional policies, and data use agreements of each participating center. Reasonable requests for access to aggregated or de-identified data may be considered by the principal investigator, subject to approval by the relevant ethics committees and participating institutions.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Based Digital Pathology Assessment in people with Prostate Cancer and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Xiangya Hospital of Central South University at 1 site 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 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Nov 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of the AI-Based Digital Pathology Model for Deep PSA Response (time frame: 6 to 7 months after initiation of ADT plus ARSI). 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 9 Nov 2026.