Clinical trial NCT04251546: Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV
Official title: Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
PSA
Keywords: Prostate Cancer
PSA
PHI
ultrasound
TPV
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 80
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases
timeFrame: 2019/05/01-2021/05/30
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
citation: 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.