BioJet system for prostate biopsy

JRCT ID: jRCT1052190098

Registered date:28/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: suspicion of prostate cancer
• Date of first enrollment: 03/10/2018
• Target sample size: 300
• Study type: Interventional
• Intervention(s): transperineal prostate needle biopsy

Outcome(s)

Primary Outcome

a) Positive prostate cancer rate by biopsy
b) Comparison of 3D cancer localization at prostate needle biopsy and the actual localization in prostatectomy specimen

Secondary Outcome

Comparison of adverse events using historical control.
(specific adverse events of prostate needle biopsy are 1. pain, 2. bleeding, 3. infection, 4. hematuria, 5. fever)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Male

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Akamatsu Shusuke