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Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p2PSA | Diagnostic Test | p2PSA test(for calculation of PHI) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases | Pathological confirmed diagnosis by transrectal ultrasound guided prostate biopsy (12 needles) according to a standardized protocol. If a suspicious low-density nodule is found during the ultrasound, biopsy to the nodule can be added. Place the prostate biopsy specimen in a 10% Formalin's specimen bag. The specimens were processed and evaluated by the Pathology Department of Xinhua Hospital. | 2019/05/01-2021/05/30 |
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Inclusion Criteria:
Exclusion Criteria:
5.Previous prostate biopsy history.
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This study selected patients with suspected prostate cancer in the Department of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from May 2019 to May 2022, and had a PSA test value of 4-10 ng / mL.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjiang Yu, MD. | Contact | 86-13916241036 | yuyongjiang@xinhuamed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35463344 | Derived | Chen H, Qian Y, Wu Y, Shi B, Zhou J, Qu F, Gu Z, Ding J, Yu Y. Modified Prostate Health Index Density Significantly Improves Clinically Significant Prostate Cancer (csPCa) Detection. Front Oncol. 2022 Apr 7;12:864111. doi: 10.3389/fonc.2022.864111. eCollection 2022. |
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| Ultrasonic parameters |
| Diagnostic Test |
Ultrasonic parameters(TPV) |
|
| Transperineal prostate biopsy | Diagnostic Test | Transperineal prostate biopsy for confirmation of prostate cancer or benign disease |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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