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

A Clinical Study on the Efficiency of Prostate Cancer Screening by the Combination of Serum PSA Assay，Multi-parametric MRI and Targeted Prostate Biopsy Among Males in Nanjing

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: multi-parametric MRI

Detailed Description

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
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
      • Contact: Jingyan Shi, MD; Phone Number: 18260098653 18260098653; Email: 18260098653@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: participants; All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.	Diagnostic test: multi-parametric MRI; Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.; Other Names: targeted prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of prostate cancer	Incidence of prostate cancer among males ≥50 years old	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	3 years

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IUNU-PC-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not willing to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No