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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317625
• Other study ID #: IUNU-PC-103
• Status: Recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Xiaozhi Zhao
• Phone: 13851744779
• Email: zhaoxz[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• mpMRI scanning
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.

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of prostate cancer	among PSA between 2.5 and 4.0 ng/ml	3 years