Prostate CancerNCT07597369
Clinically Actionable Tumor-Associated Antigens in Prostate Cancer
An observational study of Prostate Cancer and Metastatic Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Cancer (mCRPC)
- What is being tested?
- Immunohistochemistry (IHC) Staining and Analysis
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jan 2029
- Phase
- Observational
- 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
Study population: 1. Retrospective Cohorts: These four groups are defined by the origin of the archived tumor tissue specimen at Peking University First Hospital (2000-2025). Each cohort includes patients across the spectrum of disease states (castration-sensitive [CSPC] and castration-resistant [CRPC] prostate cancer) and those with special clinicopathological subtypes (e.g., neuroendocrine differentiation, cribriform/intraductal carcinoma). 2. Prospective Validation Cohort: This group will consist of patients with metastatic prostate cancer recruited at Peking University First Hospital starting January 1, 2026. Participants will provide informed consent for the use of residual tumor tissue (from any anatomic site) obtained during standard clinical care and for prospective clinical follow-up. The core material for analysis is formalin-fixed, paraffin-embedded (FFPE) tumor tissue from all participants, which will be subjected to immunohistochemical (IHC) staining for biomarker evaluation.
Who may be able to join
- For the Retrospective Cohorts (mCRPC, CSPC, Special Pathology):
- Patients with a pathological diagnosis of prostate cancer.
- Treated at Peking University First Hospital between January 2000 and 2025.
- Availability of adequate, qualified formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks for research.
- Availability of essential clinical and follow-up data in medical records.
- For the Prospective Cohort:
Show all 11Show fewer
- Age ≥ 18 years.
- CSPC, primarily includes patients who underwent neoadjuvant therapy and have paired pre- and post-treatment biopsy and surgical specimens; or patients with special clinicopathological subtypes.
- metastatic prostate cancer patients.
- Planned or recent (within 6 months prior to enrollment) acquisition of tumor tissue (from metastasis or primary site) as part of standard clinical care, with sufficient residual tissue available for the study.
- Willing and able to provide written informed consent.
Who cannot join
- For All Cohorts:
- Tumor tissue sample is of insufficient quality or quantity for immunohistochemical (IHC) analysis.
- Essential clinical or outcome data are missing or irretrievable, which would preclude meaningful analysis.
- Specifically for the Prospective Cohort:
- Any condition that, in the investigator's judgment, would significantly compromise the patient's ability to provide informed consent or comply with the study follow-up procedures.
- Patient refusal to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Expression Profiles And Prognostic Implications Of Clinically Actionable Tumor-Associated Antigens Across Diverse Clinicopathological Subtypes of Prostate Cancer: a Bidirectional Cohort Study
The goal of this observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. primary and different metastatic types，HSPC and CRPC， PC with neuroendocrine differentiation, cribriform/intraductal carcinoma).
The main questions it aims to answer are:
Read more
- What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer?
- Can the prognostic value of these targets (e.g. association with overall survival) identified in a retrospective cohort be validated in an independent prospective cohort? Researchers will head-to-head compare the expression levels among different targets and across different disease stages/metastatic site. Researchers will also assess whether the targets showing prognostic significance in the retrospective cohort can also predict survival outcomes in the prospective cohort.
Participants in the retrospective cohort have already provided archived tissue samples and clinical data. Participants in the prospective cohort (metastatic prostate cancer patients) will be invited to provide residual tumor tissue samples obtained during standard care and will be followed up regularly for clinical outcomes.
Read the detailed description
- Study Type This is a single-center, observational cohort study incorporating both retrospective and prospective components. It is a non-interventional study that does not involve assignment of participants to specific interventions.
- Objectives
Primary Objectives:
- To determine the protein expression profile (positive rate, expression level) of 15 membrane targets (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in diverse clinicopathological subtypes of prostate cancer (HSPC and CRPC，primary and metastatic lesions include lymph node, bone and visceral metastasis, etc.).
- To characterize the molecular subtypes of prostate cancer based on the expression profiles of AR, PSA, PSMA, Syn, CgA, CD56, p53, RB1, and PTEN across different disease states and metastatic sites.
- To validate the association between the expression of prognostically significant targets (identified in the retrospective cohort) and overall survival (OS) in an independent, prospectively enrolled cohort of prostate cancer patients.
Secondary Objectives:
- To compare the expression of each target between matched CSPC and mCRPC samples from the same patients.
- To compare the expression of each target across different metastatic sites (e.g., bone, lymph node, viscera) in mCRPC.
- To analyze the association between target expression and clinical outcomes [biochemical recurrence-free survival (BFS), metastasis-free survival (MFS)] in patients with CSPC.
- To explore co-expression patterns of the targets and their correlation with clinicopathological features.
3.Study Design
Retrospective Cohort:
Population: Patients treated at Peking University First Hospital between 2000-2025.
Cohort 1: Primary Tumor Cohort - This cohort includes patients with CSPC or CRPC, or those with special pathological structures, for whom primary tumor tissue (from biopsy or surgery) is available.
Cohort 2: Lymph Node Metastasis Cohort - This cohort includes patients with CSPC or CRPC for whom lymph node metastasis tissue is available (from biopsy or surgery) .
Cohort 3: Bone Metastasis Cohort - This cohort includes patients with CSPC or CRPC, for whom bone metastasis tissue is available (from biopsy or surgery).
Cohort 4: Visceral Metastasis Cohort - This cohort includes patients with CSPC or CRPC, for whom visceral (e.g., liver, lung) metastasis tissue is available.
Procedures: Archived FFPE tissue blocks will be retrieved for immunohistochemistry (IHC) staining. Clinical and follow-up data will be extracted from medical records.
Prospective Cohort:
Population: Newly diagnosed metastatic prostate cancer patients at Peking University First Hospital from January 1, 2026.
Cohort 5: Prospective Validation Cohort - This cohort will consist of patients with metastatic prostate cancer (mHSPC or mCRPC), from whom tissue samples will be collected prospectively along with their clinical data.
Procedures: Eligible patients will provide informed consent. Residual tumor tissue obtained during standard-of-care biopsies or surgeries will be collected for IHC staining. Patients will be followed prospectively at defined intervals to collect treatment and outcome data.
4.Methods Laboratory Assessment (for both cohorts): IHC will be performed on FFPE tissue sections using validated antibodies against the eight targets (as specified in the protocol: e.g., HER2: ab2142275; TROP2: ab214488; etc.). Staining will be evaluated by pathologists blinded to clinical outcomes. IHC score 0-3,0=negative/none,1=weak,2=moderate,3=strong. A modified H-score ([1×% weak staining + 2×% moderate staining + 3×% strong staining], range 0-300) will be used for quantification.
Data Collection: Clinical data (demographics, laboratory assessment (tPSA、LDH levels)，imaging data(ultrasound, MRI, CT, PET, providing TNM staging results, treatment history, pathology reports) and outcome data (biochemical recurrence, metastasis, death) will be collected retrospectively from databases/records for the retrospective cohort and prospectively during follow-up visits for the prospective cohort.
- Being tested
- Immunohistochemistry (IHC) Staining and Analysis
- Keywords
- ADC, mCRPC, NEPC, CSPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry (IHC) Staining and AnalysisOther
Immunohistochemistry staining will be performed on formalin-fixed, paraffin-embedded (FFPE) prostate cancer tissue sections to quantitatively assess the expression levels of eight membrane protein targets: PSMA, HER2, TROP2, NECTIN4, DLL3, STEAP1, B7-H3, and PDL1. This is a laboratory-based biomarker analysis and does not constitute a therapeutic intervention for participants.
| Study group | Role | What they receive |
|---|---|---|
| Primary Tumor Cohort | This retrospective cohort consists of patients with prostate cancer (encompassing castration-sensitive [CSPC], castration-resistant [CRPC] disease states, and those with special clinicopathological subtypes) for whom primary tumor tissue (from biopsy or radical prostatectomy) is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. Receives: Other: Immunohistochemistry (IHC) Staining and Analysis | |
| Lymph Node Metastasis Cohort | This retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom lymph node metastasis tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. Receives: Other: Immunohistochemistry (IHC) Staining and Analysis | |
| Bone Metastasis Cohort | This retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom bone metastasis tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. Receives: Other: Immunohistochemistry (IHC) Staining and Analysis | |
| Visceral Metastasis Cohort | This retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom visceral metastasis (e.g., liver, lung) tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. Receives: Other: Immunohistochemistry (IHC) Staining and Analysis | |
| Prospective Validation Cohort | This is a prospective, observational cohort. It will enroll metastatic prostate cancer patients (mHSPC or mCRPC) at Peking University First Hospital starting January 1, 2026. Participants will provide informed consent. Residual tumor tissue (from any site) obtained during standard-of-care procedures will be collected for biomarker analysis, and participants will be followed prospectively for clinical outcomes. No study intervention is administered. Receives: Other: Immunohistochemistry (IHC) Staining and Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression Profile in the Retrospective Prostate Cancer Cohort
The protein expression profiles of 15 tumor-associated antigens (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) and molecular subtype markers (AR, PSA, Syn, CgA, CD56, p53, RB1, and PTEN) in tumor tissues from the four retrospective site-based cohorts (Primary Tumor, Lymph Node Metastasis, Bone Metastasis, Visceral Metastasis). Measure: Expression level assessed by IHC score (0-3) , modified H-score (0-300) (positive expression defined as a H-score > 20) for each target within each cohort.
Measured: Baseline (at time of metastatic site sample acquisition)
Validation in the Prospective Cohort
The association between the expression status (positive/negative or H-score level) of prognostically significant ADC targets (identified in the retrospective cohort) and Overall Survival (OS) in the prospectively enrolled mCRPC validation cohort. This is a confirmatory analysis.
Measure: Hazard Ratio (HR) with 95% Confidence Interval (CI) from Cox proportional hazards model.
Measured: From date of prospective cohort enrollment until death from any cause, assessed up to 3 years
Secondary outcomes (4)
Target Expression Difference: Primary Tumor vs. Paired Metastasis
The difference in expression level (IHC score or H-score) for each target between primary tumor and matched metastasis (from any site) from the same patients, where such paired samples are available in the retrospective cohorts.
Measure: IHC score or H-score.
Measured: Baseline (at time of matched sample acquisition)
Target Expression Difference: Across Different Metastatic Sites
The difference in expression level (IHC score or H-score) for each target among the different metastatic sites (Lymph Node, Bone, Viscera) in the retrospective cohorts.
Measure: IHC score or H-score.
Measured: Baseline
Target Expression in Special Clinicopathological Subtypes (Subgroup Analysis)
The expression profile of the 15 tumor-associated antigens in tumor tissues with neuroendocrine differentiation or cribriform/intraductal carcinoma (CF/IDC), analyzed as a subgroup across retrospective cohorts.
Measure: IHC score or H-score.
Measured: Baseline
Prognostic Association in Retrospective Prostate Cancer Cohort
The association between tumor-associated antigens expression status and clinical outcomes in the retrospective retrospective prostate cancer cohort, with sub-analysis by disease state (CSPC vs. CRPC).
Measure: Hazard Ratios (HR) for Metastasis-free Survival (MFS) and (for CSPC sub-group) Biochemical Recurrence-free Survival (BFS).
Measured: From date of radical prostatectomy until biochemical recurrence, metastasis, or death, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (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 Peking University First HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelin Mulati, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597369
- Sponsor's protocol ID
- 2022CR16
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Profiles And Prognostic Implications Of Clinically Actionable Tumor-Associated Antigens Across Diverse Clinicopathological Subtypes of Prostate Cancer: a Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT07597369
- Acronym / sponsor ID
- 2022CR16
- Keywords
- ADC, mCRPC, NEPC, CSPC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 May 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 observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. primary and different metastatic types，HSPC and CRPC， PC with neuroendocrine differentiation, cribriform/intraductal carcinoma).
The main questions it aims to answer are:
- What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer?
- Can the prognostic value of these targets (e.g. association with overall survival) identified in a retrospective cohort be validated in an independent prospective cohort? Researchers will head-to-head compare the expression levels among different targets and across different disease stages/metastatic site. Researchers will also assess whether the targets showing prognostic significance in the retrospective cohort can also predict survival outcomes in the prospective cohort.
Participants in the retrospective cohort have already provided archived tissue samples and clinical data. Participants in the prospective cohort (metastatic prostate cancer patients) will be invited to provide residual tumor tissue samples obtained during standard care and will be followed up regularly for clinical outcomes.
Detailed description
- Study Type This is a single-center, observational cohort study incorporating both retrospective and prospective components. It is a non-interventional study that does not involve assignment of participants to specific interventions.
- Objectives
Primary Objectives:
- To determine the protein expression profile (positive rate, expression level) of 15 membrane targets (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in diverse clinicopathological subtypes of prostate cancer (HSPC and CRPC，primary and metastatic lesions include lymph node, bone and visceral metastasis, etc.).
- To characterize the molecular subtypes of prostate cancer based on the expression profiles of AR, PSA, PSMA, Syn, CgA, CD56, p53, RB1, and PTEN across different disease states and metastatic sites.
- To validate the association between the expression of prognostically significant targets (identified in the retrospective cohort) and overall survival (OS) in an independent, prospectively enrolled cohort of prostate cancer patients.
Secondary Objectives:
- To compare the expression of each target between matched CSPC and mCRPC samples from the same patients.
- To compare the expression of each target across different metastatic sites (e.g., bone, lymph node, viscera) in mCRPC.
- To analyze the association between target expression and clinical outcomes [biochemical recurrence-free survival (BFS), metastasis-free survival (MFS)] in patients with CSPC.
- To explore co-expression patterns of the targets and their correlation with clinicopathological features.
3.Study Design
Retrospective Cohort:
Population: Patients treated at Peking University First Hospital between 2000-2025.
Cohort 1: Primary Tumor Cohort - This cohort includes patients with CSPC or CRPC, or those with special pathological structures, for whom primary tumor tissue (from biopsy or surgery) is available.
Cohort 2: Lymph Node Metastasis Cohort - This cohort includes patients with CSPC or CRPC for whom lymph node metastasis tissue is available (from biopsy or surgery) .
Cohort 3: Bone Metastasis Cohort - This cohort includes patients with CSPC or CRPC, for whom bone metastasis tissue is available (from biopsy or surgery).
Cohort 4: Visceral Metastasis Cohort - This cohort includes patients with CSPC or CRPC, for whom visceral (e.g., liver, lung) metastasis tissue is available.
Procedures: Archived FFPE tissue blocks will be retrieved for immunohistochemistry (IHC) staining. Clinical and follow-up data will be extracted from medical records.
Prospective Cohort:
Population: Newly diagnosed metastatic prostate cancer patients at Peking University First Hospital from January 1, 2026.
Cohort 5: Prospective Validation Cohort - This cohort will consist of patients with metastatic prostate cancer (mHSPC or mCRPC), from whom tissue samples will be collected prospectively along with their clinical data.
Procedures: Eligible patients will provide informed consent. Residual tumor tissue obtained during standard-of-care biopsies or surgeries will be collected for IHC staining. Patients will be followed prospectively at defined intervals to collect treatment and outcome data.
4.Methods Laboratory Assessment (for both cohorts): IHC will be performed on FFPE tissue sections using validated antibodies against the eight targets (as specified in the protocol: e.g., HER2: ab2142275; TROP2: ab214488; etc.). Staining will be evaluated by pathologists blinded to clinical outcomes. IHC score 0-3,0=negative/none,1=weak,2=moderate,3=strong. A modified H-score ([1×% weak staining + 2×% moderate staining + 3×% strong staining], range 0-300) will be used for quantification.
Data Collection: Clinical data (demographics, laboratory assessment (tPSA、LDH levels)，imaging data(ultrasound, MRI, CT, PET, providing TNM staging results, treatment history, pathology reports) and outcome data (biochemical recurrence, metastasis, death) will be collected retrospectively from databases/records for the retrospective cohort and prospectively during follow-up visits for the prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Primary Tumor Cohort | – | Other: Immunohistochemistry (IHC) Staining and AnalysisThis retrospective cohort consists of patients with prostate cancer (encompassing castration-sensitive [CSPC], castration-resistant [CRPC] disease states, and those with special clinicopathological subtypes) for whom primary tumor tissue (from biopsy or radical prostatectomy) is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. |
| Lymph Node Metastasis Cohort | – | Other: Immunohistochemistry (IHC) Staining and AnalysisThis retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom lymph node metastasis tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. |
| Bone Metastasis Cohort | – | Other: Immunohistochemistry (IHC) Staining and AnalysisThis retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom bone metastasis tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. |
| Visceral Metastasis Cohort | – | Other: Immunohistochemistry (IHC) Staining and AnalysisThis retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom visceral metastasis (e.g., liver, lung) tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered. |
| Prospective Validation Cohort | – | Other: Immunohistochemistry (IHC) Staining and AnalysisThis is a prospective, observational cohort. It will enroll metastatic prostate cancer patients (mHSPC or mCRPC) at Peking University First Hospital starting January 1, 2026. Participants will provide informed consent. Residual tumor tissue (from any site) obtained during standard-of-care procedures will be collected for biomarker analysis, and participants will be followed prospectively for clinical outcomes. No study intervention is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Retrospective Cohorts: These four groups are defined by the origin of the archived tumor tissue specimen at Peking University First Hospital (2000-2025). Each cohort includes patients across the spectrum of disease states (castration-sensitive [CSPC] and castration-resistant [CRPC] prostate cancer) and those with special clinicopathological subtypes (e.g., neuroendocrine differentiation, cribriform/intraductal carcinoma). 2. Prospective Validation Cohort: This group will consist of patients with metastatic prostate cancer recruited at Peking University First Hospital starting January 1, 2026. Participants will provide informed consent for the use of residual tumor tissue (from any anatomic site) obtained during standard clinical care and for prospective clinical follow-up. The core material for analysis is formalin-fixed, paraffin-embedded (FFPE) tumor tissue from all participants, which will be subjected to immunohistochemical (IHC) staining for biomarker evaluation.
Key inclusion criteria (11 listed)
- For the Retrospective Cohorts (mCRPC, CSPC, Special Pathology):
- For the Prospective Cohort:
Key exclusion criteria (6 listed)
- For All Cohorts:
- Specifically for the Prospective Cohort:
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 |
|---|---|---|
| Immunohistochemistry (IHC) Staining and AnalysisImmunohistochemistry staining will be performed on formalin-fixed, paraffin-embedded (FFPE) prostate cancer tissue sections to quantitatively assess the expression levels of eight membrane protein targets: PSMA, HER2, TROP2, NECTIN4, DLL3, STEAP1, B7-H3, and PDL1. This is a laboratory-based biomarker analysis and does not constitute a therapeutic intervention for participants. | Other | Bone Metastasis Cohort, Lymph Node Metastasis Cohort, Primary Tumor Cohort, Prospective Validation Cohort, Visceral Metastasis Cohort |
Primary outcome
Expression Profile in the Retrospective Prostate Cancer Cohort
Time frame: Baseline (at time of metastatic site sample acquisition)
The protein expression profiles of 15 tumor-associated antigens (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) and molecular subtype markers (AR, PSA, Syn, CgA, CD56, p53, RB1, and PTEN) in tumor tissues from the four retrospective site-based cohorts (Primary Tumor, Lymph Node Metastasis, Bone Metastasis, Visceral Metastasis). Measure: Expression level assessed by IHC score (0-3) , modified H-score (0-300) (positive expression defined as a H-score > 20) for each target within each cohort.
Validation in the Prospective Cohort
Time frame: From date of prospective cohort enrollment until death from any cause, assessed up to 3 years
The association between the expression status (positive/negative or H-score level) of prognostically significant ADC targets (identified in the retrospective cohort) and Overall Survival (OS) in the prospectively enrolled mCRPC validation cohort. This is a confirmatory analysis. Measure: Hazard Ratio (HR) with 95% Confidence Interval (CI) from Cox proportional hazards model.
4 secondary outcomes
Target Expression Difference: Primary Tumor vs. Paired Metastasis
Time frame: Baseline (at time of matched sample acquisition)
Target Expression Difference: Across Different Metastatic Sites
Time frame: Baseline
Target Expression in Special Clinicopathological Subtypes (Subgroup Analysis)
Time frame: Baseline
Prognostic Association in Retrospective Prostate Cancer Cohort
Time frame: From date of radical prostatectomy until biochemical recurrence, metastasis, or death, assessed up to 10 years
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 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Prostate Cancer and Metastatic Prostate Cancer, run by Peking University First Hospital 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 11 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 15 Jun 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?
Expression Profile in the Retrospective Prostate Cancer Cohort (time frame: Baseline (at time of metastatic site sample acquisition)). The study lists 2 primary outcomes in all. 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 15 Jun 2026.