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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mpMRI scanning
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

participants

Arm Description

All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.

Outcomes

Primary Outcome Measures

Incidence of prostate cancer
among PSA between 2.5 and 4.0 ng/ml

Secondary Outcome Measures

Full Information

First Posted
January 27, 2020
Last Updated
March 20, 2020
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04317625
Brief Title
Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
Official Title
Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
participants
Arm Type
Experimental
Arm Description
All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.
Intervention Type
Diagnostic Test
Intervention Name(s)
mpMRI scanning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of prostate cancer
Description
among PSA between 2.5 and 4.0 ng/ml
Time Frame
3 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate cancer screening is limited only among males
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhi Zhao
Phone
13851744779
Ext
13851744779
Email
zhaoxz@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqian Guo
Phone
13605171690
Ext
13605171690
Email
dr.ghq@nju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqian Guo
Organizational Affiliation
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyan Shi, MD
Phone
18260098653
Ext
18260098653
Email
18260098653@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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