BioJet system for prostate biopsy

Phase 4

• Conditions: suspicion of prostate cancer; prostate cancer, biopsy, MRI; D011471

• Registration Number: JPRN-jRCT1052190098
• Lead Sponsor: Akamatsu Shusuke

Brief Summary

MRI/US fusion prostate needle biopsy using BioJET was useful to diagnose clinically significant cancer efficiently without increasing the diagnosis of non-significant indolent cancer. In addition, there was no adverse event associated with the procedure, and the procedure was proven to be safer than conventional transrectal needle biopsy. On the other hand, when the biopsy result was compared with the whole mount prostatectomy specimen, it was evident that especially during the period of initial experience,

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-28
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 139

Inclusion Criteria

Patients that fulfill criteria I and either II or III who are eligible for prostatectomy and can give consent to the study.
I. Serum PSA elevation (>=2.5ng/ml, <=20ng/ml
II. suspicious of localized prostate cancer by digital rectal exam
III. suspicious of localized prostate cancer by MRI
Iv. age >=20, <90

Exclusion Criteria

Either of the below.
I. patients who would not benefit from diagnoses of prostate cancer
II. patients with PSA >=20ng/ml, who are likely to have advanced prostate cancer
III. suspicious of advanced prostate cancer by digital rectal exam
IV. suspicious of advanced prostate cancer by MRI
V. patients who cannot undergo prostate biopsy due to coagulation disorders
VI. patients who are not eligible for spinal, sacral, or general anesthesia due to allergy
VII. patients who are not eligible for the study determined by the treating physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified