Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening

N/AUnknownNCT04322045

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School10,000 enrolled

Overview

The study aims to investigate the incidence of prostate cancer among males in Nanjing and whether a combination of PSA, multi-parametric MRI and targeted biopsy is a feasible approach for screening prostate cancer in China.

The investigators are going to collect serum samples and clinical information from men aged ≥50 years taking physical examination in community health service centers in Nanjing. The investigators will propose mpMRI for those with serum PSA ≥4 ng/mL. Transperineal systematic biopsy (TPSB) combined with MRI /ultrasound fusion targeted biopsy (TB) will be offered for those scored ≥3 on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). TPSB alone will be offered for those scored \<3 and serum PSA ≥10 ng/mL. Subjects with serum PSA between 4 ng/mL and 10 ng/mL and PI-RADS score \<3 points will be referred to follow-up examinations every 6 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

10,000

Conditions

Prostate Cancer

Interventions

multi-parametric MRIDIAGNOSTIC_TEST

Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 50 * (Eastern Cooperative Oncology Group)ECOG grade: 0-1 * Normal organic function indexes: * (absolute neutrophil count)ANC ≧1.5×109/L * (platelet count)PLT ≧100×109/L * Hb ≧90 g/L * (total bilirubin)TBIL ≦1.5×ULN * (aspartate aminotransferase)ALT≦2.5×ULN * (alanine aminotransferase)AST ≦2.5×ULN * (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN Exclusion Criteria: * Former serum PSA detection * Having took Proscar in the past 3 months * Suffered from any other malignant tumor in the past 5 years * History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system * Having took Proscar in the past 3 months * Suffered from any other malignant tumor in the past 5 years * History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of prostate cancer

Incidence of prostate cancer among males ≥50 years old

Time frame: 3 years

Secondary Outcomes

Number of participants with different gleason scores

Gleason score of prostate cancer patients, Including 7 degrees:3+3=6,3+4=7,4+3=7,4+4=8,4+5=9,5+4=9,5+5=10.

Time frame: 3 years

Number of participants with different clinical stages

Clinical stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer.

Time frame: 3 years

Number of participants with different risk groups

Devided to three risk groups(high-medium-low) according to D'Amico risk groups of prostate cancer.

Time frame: 3 years

Number of participants with different prognostic stage groups

Prognostic stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer.

Time frame: 3 years

Central Contacts

Xiaozhi Zhao

CONTACT

13851744779 zhaoxz@nju.edu.cn

Hongqian Guo

CONTACT

13605171690 dr.ghq@nju.edu.cn

Data from ClinicalTrials.gov

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