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Clinical Trials/NCT04251546
NCT04251546
Unknown
N/A

Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country80 target enrollmentJanuary 4, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
80
Locations
1
Primary Endpoint
Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2020
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient\> 45 years of age
  • Abnormal serum PSA
  • Prostate nodules found by DRE
  • Abnormal MRI or TRUS finding

Exclusion Criteria

  • Incomplete medical history
  • Poor quality of serum samples
  • 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.

Outcomes

Primary Outcomes

Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases

Time Frame: 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.

Study Sites (1)

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