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This is a single center prospective non-randomized controlled study.
The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are:
Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The combination of PSMA-PET/MR and p2PSA | Experimental |
| |
| The combination of mpMRI and p2PSA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate biopsy | Diagnostic Test | Targeted guided puncture biopsy guided by B-ultrasound will be performed (in addition to 12-needle system biopsy, if PSMA-PET/MRI or mpMRI indicates a positive lesion, puncture biopsy should be added at the lesion displayed on image, the "12-needle system biopsy+X" scheme). |
| Measure | Description | Time Frame |
|---|---|---|
| biospy outcome | Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between both methods and set up a diagnostic model. | 12 months |
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Inclusion Criteria:
Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage<T3, while meeting one of the following criteria:
â‘ Digital rectal examination revealed suspicious nodules of the prostate;
â‘¡ Transrectal prostate ultrasound or MRI found suspicious lesions;
â‘¢ PSA>10 ng/mlï¼›
â‘£ PSA 4~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
Aged between 18 and 85 years;
Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc;
Provide a signed and dated informed consent form;
Commit to complying with research procedures and cooperate in the implementation of the entire process of research.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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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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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |