Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
1 other identifier
interventional
232
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 23, 2020
March 1, 2020
2.7 years
January 27, 2020
March 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of prostate cancer
among PSA between 2.5 and 4.0 ng/ml
3 years
Study Arms (1)
participants
EXPERIMENTALAll of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hongqian Guo
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
Central Study Contacts
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 23, 2020
Study Start
April 1, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 23, 2020
Record last verified: 2020-03