Prostate Cancer, PSA
Conditions
Keywords
Prostate Cancer, PSA, PHI, ultrasound, TPV
Brief summary
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.
Interventions
DIAGNOSTIC_TESTp2PSA
p2PSA test(for calculation of PHI)
DIAGNOSTIC_TESTUltrasonic parameters
Ultrasonic parameters(TPV)
DIAGNOSTIC_TESTTransperineal prostate biopsy
Transperineal prostate biopsy for confirmation of prostate cancer or benign disease
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient\> 45 years of age 2. Abnormal serum PSA 3. Prostate nodules found by DRE 4. Abnormal MRI or TRUS finding
Exclusion criteria
1. Incomplete medical history 2. Poor quality of serum samples 3. Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy 5.Previous prostate biopsy history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases | 2019/05/01-2021/05/30 | 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. |
Countries
China
Contacts
Primary ContactYongjiang Yu, MD.
Outcome results
None listed