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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251546
• Other study ID #: XH-20-002
• Status: Recruiting
• Start date: January 4, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yongjiang Yu, MD.
• Phone: 86-13916241036
• Email: yuyongjiang[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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 4.5a reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy

5.Previous prostate biopsy history.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• PSA

Intervention

Diagnostic Test:
• p2PSA
p2PSA test(for calculation of PHI)
• Ultrasonic parameters
Ultrasonic parameters(TPV)
• Transperineal prostate biopsy
Transperineal prostate biopsy for confirmation of prostate cancer or benign disease

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases	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.	2019/05/01-2021/05/30