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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 19 February 2024
cancer diagnosis
prostate specific antigen
digital rectal examination
transrectal ultrasound
biopsy of prostate
transperineal biopsy
prostate health index

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.

Details
Condition Malignant neoplasm of prostate, PROSTATE SPECIFIC ANTIGEN, Prostatic disorder
Age 45years - 100years
Treatment p2PSA ,ultrasonic parameters and transperineal prostate biopsy
Clinical Study IdentifierNCT04251546
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient> 45 years of age, with abnormal serum PSA, with or without digital rectal examination (DRE), with indications for prostate biopsy
Prostate biopsy indications
(1) DRE found prostate nodules; (2) MRI, TRUS and other examinations found
abnormalities; (3) f / tPSA is abnormal or PSAD value is abnormal. 3. Criteria
for diagnosis of prostate cancer: The pathological results of transrectal
ultrasound-guided prostate biopsy (12 needles), Gleason score is based on the
diagnosis of pathology

Exclusion Criteria

Incomplete medical history; poor quality of serum samples; bacterial acute
prostatitis diagnosed within 3 months before biopsy; 5 reductase inhibitors
anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy
patient with previous prostate biopsy history
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