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

NCT ID: NCT04251546

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-04
• Study Completion Date: 2022-09-30

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.

Conditions

Prostate Cancer; PSA

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational group

Patients with suspected prostate cancer with a PSA test value of 4-10 ng / mL

p2PSA

Intervention Type: DIAGNOSTIC_TEST

p2PSA test(for calculation of PHI)

Ultrasonic parameters

Intervention Type: DIAGNOSTIC_TEST

Ultrasonic parameters(TPV)

Transperineal prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

Transperineal prostate biopsy for confirmation of prostate cancer or benign disease

Interventions

p2PSA

p2PSA test(for calculation of PHI)

Intervention Type: DIAGNOSTIC_TEST

Ultrasonic parameters

Ultrasonic parameters(TPV)

Intervention Type: DIAGNOSTIC_TEST

Transperineal prostate biopsy

Transperineal prostate biopsy for confirmation of prostate cancer or benign disease

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjiang Yu, MD.

Role: CONTACT

yuyongjiang@xinhuamed.com.cn

86-13916241036

Facility Contacts

Guangyu Chen, MD.

Role: primary

chenguangyu@xinhuamed.com.cn

+86-1356414407

References

Chen H, Qian Y, Wu Y, Shi B, Zhou J, Qu F, Gu Z, Ding J, Yu Y. Modified Prostate Health Index Density Significantly Improves Clinically Significant Prostate Cancer (csPCa) Detection. Front Oncol. 2022 Apr 7;12:864111. doi: 10.3389/fonc.2022.864111. eCollection 2022.

Reference Type: DERIVED

PMID: 35463344 (View on PubMed)

Other Identifiers

XH-20-002

Identifier Type: -

Identifier Source: org_study_id