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| Name | Class |
|---|---|
| Shanghai East Hospital of Tongji University | OTHER |
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This study aims to establish a prospective exploratory cohort and database to observe the dynamic evolution of bi-parametric MRI (bpMRI). Investigators intend to study the clinical utility of sequential MRI combined with prostate biopsy in the diagnosis of prostate cancer. Specifically, by utilizing bpMRI findings and their dynamic changes to guide the timing of biopsies, investigators aim to avoid unnecessary procedures. Furthermore, the safety and efficacy of this strategy will be assessed through long-term follow-up, ultimately promoting the precision diagnosis and treatment of prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI follow-up cohort of patients with clinically suspected prostate cancer | Scheduled Follow-up: All enrolled patients will undergo a follow-up period of 24 months. Every 6 months: PSA testing, Digital Rectal Examination (DRE), and clinical assessment. At months 12 and 24: Repeat bi-parametric MRI (bpMRI) examinations. Biopsy Decision-Making: Triggered Biopsy: During the follow-up period (e.g., at month 12), a prostate biopsy will be recommended if the patient exhibits MRI progression to PI-RADS 4/5, or presents with PI-RADS 3 combined with a PSA density (PSAD) > 0.2 ng/ml². Endpoint Biopsy: To ensure study rigor and safety, patients who have not undergone biopsy due to radiological progression during the 24-month follow-up will be advised to undergo a confirmatory biopsy at the study endpoint (month 24). This aims to maximally exclude the missed diagnosis of clinically significant prostate cancer (csPCa). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA test | Diagnostic Test | Blood PSA test every 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| csPCa detection rate | Clinically significant prostate cancer detection rates across different radiological changes (progression, stability, and regression) | From enrollment to the end of follow up at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with clinical suspicion of prostate cancer presenting to Peking University First Hospital and Shanghai East Hospital (Affiliated to Tongji University)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Liu, Medical Doctor | Contact | +86 13611035261 | liuyipkuhsc@163.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Prostate biopsy tissue for pathological diagnosis
| Bi parametric MRI | Diagnostic Test | Bi parametric MRI examination every year. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |