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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multi-parametric MRI
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
  • (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

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 tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.

Outcomes

Primary Outcome Measures

Incidence of prostate cancer
Incidence of prostate cancer among males ≥50 years old

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2020
Last Updated
March 23, 2020
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04322045
Brief Title
Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening
Official Title
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
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
participants
Arm Type
Experimental
Arm Description
All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.
Intervention Type
Diagnostic Test
Intervention Name(s)
multi-parametric MRI
Other Intervention Name(s)
targeted prostate biopsy
Intervention Description
Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.
Primary Outcome Measure Information:
Title
Incidence of prostate cancer
Description
Incidence of prostate cancer among males ≥50 years old
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of participants with different gleason scores
Description
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
Title
Number of participants with different clinical stages
Description
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
Title
Number of participants with different risk groups
Description
Devided to three risk groups(high-medium-low) according to D'Amico risk groups of prostate cancer.
Time Frame
3 years
Title
Number of participants with different prognostic stage groups
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Screening for prostate cancer is conducted only among males
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
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

Plan to Share IPD
No
IPD Sharing Plan Description
not willing to share

Learn more about this trial

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

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