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

NCT04251546 | Unknown

• 1 other identifier: XH-20-002
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate Cancer; PSA; PHI; ultrasound; TPV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational group

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

Diagnostic Test: p2PSA; Diagnostic Test: Ultrasonic parameters; Diagnostic Test: Transperineal prostate biopsy

Interventions

p2PSA DIAGNOSTIC_TEST

p2PSA test(for calculation of PHI)

Observational group

Ultrasonic parameters DIAGNOSTIC_TEST

Ultrasonic parameters(TPV)

Observational group

Transperineal prostate biopsy DIAGNOSTIC_TEST

Transperineal prostate biopsy for confirmation of prostate cancer or benign disease

Observational group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study selected patients with suspected prostate cancer in the Department of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine from May 2019 to May 2022, and had a PSA test value of 4-10 ng / mL.

You may qualify if:

• Patient\> 45 years of age
• Abnormal serum PSA
• Prostate nodules found by DRE
• Abnormal MRI or TRUS finding

You may not qualify if:

• Incomplete medical history
• Poor quality of serum samples
• Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy
• Previous prostate biopsy history.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35463344 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Yongjiang Yu, MD.

CONTACT

86-13916241036; yuyongjiang@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 4, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (1)