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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04317625
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: mpMRI scanning Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: participants
All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.
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.




Primary Outcome Measures :
  1. Incidence of prostate cancer [ Time Frame: 3 years ]
    among PSA between 2.5 and 4.0 ng/ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostate cancer screening is limited only among males
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317625


Contacts
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Contact: Xiaozhi Zhao 13851744779 ext 13851744779 zhaoxz@nju.edu.cn
Contact: Hongqian Guo 13605171690 ext 13605171690 dr.ghq@nju.edu.cn

Locations
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China, Jiangsu
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jingyan Shi, MD    18260098653 ext 18260098653    18260098653@163.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Study Chair: Hongqian Guo Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
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Responsible Party: 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 School
ClinicalTrials.gov Identifier: NCT04317625    
Other Study ID Numbers: IUNU-PC-103
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases