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

• Conditions: Prostate Cancer; PSA
• Interventions: Diagnostic Test: p2PSA; Diagnostic Test: Ultrasonic parameters; Diagnostic Test: Transperineal prostate biopsy

• Registration Number: NCT04251546
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-04
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	p2PSA	Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL
Observational group	Transperineal prostate biopsy	Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL
Observational group	Ultrasonic parameters	Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China