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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.
Age
45 - No limit years
Sex
MALE
Healthy Volunteers
No
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Start Date
January 4, 2020
Primary Completion Date
September 30, 2022
Completion Date
September 30, 2022
Last Updated
May 6, 2022
80
ESTIMATED participants
p2PSA
DIAGNOSTIC_TEST
Ultrasonic parameters
DIAGNOSTIC_TEST
Transperineal prostate biopsy
DIAGNOSTIC_TEST
Lead Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT05691465