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BioJet system for prostate biopsy

Can localization of prostate cancer be improved with the use of BioJet system for prostate biopsy?

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052190098
Enrollment
300
Registered
2020-01-28
Start date
2018-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

suspicion of prostate cancer prostate cancer, biopsy, MRI

Interventions

D061705
prostate needle biopsy

Sponsors

Akamatsu Shusuke
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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, =20, <90

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Contacts

Public ContactShusuke Akamatsu

Kyoto University Hospital

akamats@kuhp.kyoto-u.ac.jp+81-757513337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026