NCT04322045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

January 27, 2020

Last Update Submit

March 23, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of prostate cancer

    Incidence of prostate cancer among males ≥50 years old

    3 years

Secondary Outcomes (4)

  • Number of participants with different gleason scores

    3 years

  • Number of participants with different clinical stages

    3 years

  • Number of participants with different risk groups

    3 years

  • Number of participants with different prognostic stage groups

    3 years

Study Arms (1)

participants

EXPERIMENTAL

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

Diagnostic Test: multi-parametric MRI

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.

Also known as: targeted prostate biopsy
participants

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsScreening for prostate cancer is conducted only among males
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Xiaozhi Zhao

CONTACT

13851744779zhaoxz@nju.edu.cn

Hongqian Guo

CONTACT

13605171690dr.ghq@nju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

First Submitted

January 27, 2020

First Posted

March 26, 2020

Study Start

April 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

not willing to share

Locations

CN(1)