Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy: comparison of the evaluation system (PI-RADS category vs. PI-RADS + US evalutaion)

Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy: comparison of the evaluation system (PI-RADS category vs. PI-RADS + US evalutaion) - Detection of clinically significant prostate cancer with MRI-TRUS fusion image-guided biopsy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050631

Enrollment

Registered

2023-03-20

Start date

2023-02-01

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

Suspected prostate cancer

Interventions

Ultrasound imaging (gray scale, Doppler, elastography)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients with PSA value and less than 20 ng/mL Patients who were suspected as having prostate significant cancer on MRI (with and larger than PI-RADS category 3) Patients who will be performed MRI-TRUS fusion image-guided biopsy and systematic biopsy with trans-perineal approach. Patients who agreed with the informed consent

Exclusion criteria

Exclusion criteria: Patients who disagreed with the informed consent Patients who are deemed inappropriate by the principal investigator or subinvestigator.

Design outcomes

Primary

Measure	Time frame
Significant cancer detection	—

Secondary

Measure	Time frame
1. Evaluation time of ultrasound 2. Revision rates of PI-RADS+US category from PI-RADS category 3. Difference of significant cancer detections between target and systematic biopsies 4. Safety (CTCAE v.5.0) during procedure and within 1 month after the procedure	—

Countries

Japan

Contacts

Public ContactSUNAO SHOJI

Tokai University Department of Urology

sunashoj@mail.goo.ne.jp0463-93-1121

Outcome results

None listed

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