Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

March 20, 2020 updated by: Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

The study aims to evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score <3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.

Study Type

Interventional

Enrollment (Anticipated)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • PSA between 2.5 and 4.0ng/ml
  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participants
All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.
Diagnostic test: mpMRI scanning
The patients whose PSA levels are between 2.5 and 4.0ng/ml will be recommended to mpMRI scanning at first but not biopsy or active surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of prostate cancer
Time Frame: 3 years
among PSA between 2.5 and 4.0 ng/ml
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUNU-PC-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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