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Trial Title:
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
NCT ID:
NCT06504017
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
COG-TB: Cognitive Fusion guided prostate targeted Biopsy
Description:
Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
Arm group label:
COG-TB: Cognitive Fusion guided prostate targeted Biopsy
Intervention type:
Procedure
Intervention name:
FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
Description:
MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
Arm group label:
FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
Summary:
To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with
PI-RADS 4 small lesions.
Detailed description:
Prostate cancer (PCA) is the most frequent malignancy in male urogenital system.
According to the World Health Organization's 2020 GLOBOCAN statistics, there are
approximately 1.4 million new cases and 375,000 deaths worldwide. PCa is the second most
common tumor in male patients after lung cancer and ranks fifth among cancer causes of
death.
Currently, prostate specific antigen ( PSA ), digital rectal examination (DRE),
multi-parametric magnetic resonance imaging (mpMRI), prostate specific membrane antigen
positron emission Tomography/computed tomography (PSMA PET/CT) and other detection
methods have played an important role in the diagnosis of PCa, but the gold standard for
confirming PCa is the histopathological examination of prostate biopsy. Performing mpMRI
before biopsy can help detect and locate prostate cancer with ISUP grade ≥2. Studies have
shown that the prostate imaging reporting and data system (PI-RADS) may help improve the
detection of clinically significant cancers. Biopsy should be considered when PI-RADS
score 4 or 5.
This clinical study intends to use the mpMRI-TRUS image fusion ultrasound system to
assist in guiding FUS-TB, comparing to COG-TB to evaluate the application value of
mpMR-TRUS image fusion in the detection of PCa in prostate biopsy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) male who are between 18 to 80 years old; 2) meet any of the following criteria:
1. suspicious nodules of prostate under digital rectal examination(DRE), with any
PSA value;
2. PSA≥10μg/L;
3. 4μg/L≤PSA<10μg/L,f/t PSA≤0.16; 3) suspicious lesions under mpMRI, at least one
lesion <5mm, PI-RADS 4; 4) good compliance; 5) must sign the informed consent
form.
Exclusion Criteria:
-
1) diagnosed prostate cancer or acute prostatitis; 2) acute infection, or
clinically significant urinary tract infection; 3) performed prostate puncture
within 1 month; 4) cardiac insufficiency; 5) having high risk of bleeding or
taking anticoagulants for a long time; 6) severe internal or external
hemorrhoids, perianal or rectal lesions; 7) having severe osteoarticular
diseases that can not be performed lithotomy; 8) hypertensive crisis; 9)
patients who should not be anesthetized; 10) patients with mental illness or
mental disorders and unable to understand the informed consent; 11) patients
with electronic devices such as built-in artificial pacemaker, cochlear
implants or nerve stimulators; 12) other surgical contraindications, or those
considered unsuitable by the investigators.
Gender:
Male
Gender based:
Yes
Gender description:
The prostate is unique to men
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
August 2024
Completion date:
August 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Huai'an First People's Hospital
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06504017
