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The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy.
Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy
Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.
Prostate Specific Antigen (PSA) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. At present, PSA<4 ng/ml is considered as the normal value, and PSA 4-10 ng/ml is considered as the gray value. PSA>10 ng/ml should be highly suspected of prostate cancer. Prostate biopsy is still the gold standard for the diagnosis of prostate cancer. However, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. There is a growing trend to reduce unnecessary prostate biopsies.
Prostate specific membrane antigen (PSMA) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. In recent years, radioactive nuclide 18F labeling targeting PSMA positron emission tomography/computed tomography (PET/CT) has shown important clinical application value in prostate cancer recurrence monitoring.
The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone.
Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo biopsy
Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Prostate Cancer | Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed non-prostate cancer after biopsies | ||
| Prostate Cancer | Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed prostate cancer after biopsies |
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| Measure | Description | Time Frame |
|---|---|---|
| detection rate of prostate cancer | detection rate of prostate cancer | about 1 year |
| detection rate of clinical significant prostate cancer | detection rate of clinical significant prostate cancer | about 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| gleason score group prediction | Using biopsy histopathology as standard, patients will be classified as gleason score 6-10. We use PSMA PET and genomics to predict gleason score group | about 1 year |
| expression level of survival-related genes |
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Inclusion Criteria:
Exclusion Criteria:
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-Patients with elevated PSA levels in the First Affiliated Hospital of Xi'an Jiaotong University be included in this study with signed informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Zhuonan Wang, Ph.D. | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702584 | Derived | Luo L, Wang R, Bai L, Shang J, Wang X, Chang R, Dong W, Li Y, Li Y, Liang H, Xie H, Duan X. The accuracy of fluorine 18-labelled prostate-specific membrane antigen PET/CT and MRI for diagnosis of prostate cancer in PSA grey zone. Br J Cancer. 2025 Feb;132(3):253-258. doi: 10.1038/s41416-024-02934-x. Epub 2024 Dec 19. |
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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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RNA expression and gene mutation
Using RNA sequence to evaluate the expression level of survival-related genes
| about 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |