Clinically Actionable Tumor-Associated Antigens in Prostate Cancer (NCT07597369) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinically Actionable Tumor-Associated Antigens in Prostate Cancer
China1,600 participantsStarted 2026-01-01
Plain-language 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. primary and different metastatic types，HSPC and CRPC， PC with neuroendocrine differentiation, cribriform/intraductal carcinoma).
The main questions it aims to answer are:
1. What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer?
2. 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expression Profile in the Retrospective Prostate Cancer Cohort
Timeframe: Baseline (at time of metastatic site sample acquisition)
2
Validation in the Prospective Cohort
Timeframe: From date of prospective cohort enrollment until death from any cause, assessed up to 3 years
. 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.
Exclusion criteria
. 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.
. 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.