FUS-TB VS COG-TB in Small Lesions of Prostate Cancer

NCT06504017 | Not Yet Recruiting

• 1 other identifier: 2024-SR-359
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• detection rate of any PCa

  detection rate of any prostate cancer

  1 week (after pathology）

Secondary Outcomes (1)

• detection rate(cs PCa and PCa) of TBx

  1 week (after pathology）

Study Arms (2)

COG-TB: Cognitive Fusion guided prostate targeted Biopsy

OTHER

Targeted Biopsy 4 cores under cognitive fusion ultrasound

Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy

FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy

EXPERIMENTAL

Targeted Biopsy 4 cores under MRI-TRUS Fusion ultrasound

Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy

Interventions

COG-TB: Cognitive Fusion guided prostate targeted Biopsy PROCEDURE

Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

COG-TB: Cognitive Fusion guided prostate targeted Biopsy

FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy PROCEDURE

MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: The prostate is unique to men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) male who are between 18 to 80 years old; 2) meet any of the following criteria:
• suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value;
• PSA≥10μg/L;
• μg/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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Huai'an First People's Hospital: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shangqian Wang, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangqian Wang, PhD

CONTACT

0086-025-68306360; wsq5501@126.com

Xu Wang

CONTACT

0086-025-68306360; jsphkj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share