Combined Prostate-specific Antigen, Multi-parametric MRI... | NCT04322045

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

NCT04322045

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Status

Unknown status

Last Update Posted

Mar 26, 2020Actual

Enrollment

10,000Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

multi-parametric MRI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 27, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 26, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongqian Guo, Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPrincipal Investigator

Lead Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
participants	Experimental	All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.	Diagnostic Test: multi-parametric MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multi-parametric MRI	Diagnostic Test	Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.	participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Screening for prostate cancer is conducted only among males

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaozhi Zhao	Contact	13851744779	13851744779	zhaoxz@nju.edu.cn
Hongqian Guo	Contact	13605171690	13605171690	dr.ghq@nju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Recruiting	Nanjing	Jiangsu	210000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

not willing to share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081364	Multiparametric Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D008279	Magnetic Resonance Imaging
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided