The Effectiveness and Safety probability of Magnetic Resonance/Ultrasound Image Fusion System guided Prostate Target Biopsy in Patients with Suspected Prostate Cancer: A Multicenter, Prospective study

The Effectiveness and Safety probability of Magnetic Resonance/Ultrasound Image Fusion System guided Prostate Target Biopsy in Biopsy naive Men with Elevated Prostate specific Antigen: A Multicenter, Prospective study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007092

Enrollment

390

Registered

2022-03-18

Start date

2022-01-15

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

None listed

Interventions

Procedure/Surgery : 1. Transrectal prostate biopsy 1) Preparations for biopsy - The test is performed on the crushed stone (the state in which the legs are spread on both sides while lying down). A lo

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Men over 19 and under 80 - Patients who have clinically suspected prostate cancer and planned a biopsy (at least one of the criteria below) a. Serum PSA >3ng/ml and ?50ng/ml b. Suspicion of a nodule on the direct upper hand test (DRE) c. Abnormal lesions on rectal ultrasonography (TRUS) - Patients with PI-RADS 3 or higher lesions on MRI - Patients who can understand the contents of the consent form and voluntarily consent

Exclusion criteria

Exclusion criteria: - Patients previously histologically diagnosed with prostate cancer - Those who are contraindicated in MRI - Those who are contraindicated in prostate biopsy - Those who are expected to have artifacts in the MRI image due to previous hip replacement surgery or pelvic surgery history - Those who have a tendency to hemorrhage and are receiving anticoagulant/antiplatelet medication - Acute urinary tract infection - Those with hemorrhoids/anal fissures/anal fistula - Those with a previous history of allergy to lidocaine - Those who are judged to be inappropriate to participate in clinical trials in the judgment of other investigators - Those who are participating in other research

Design outcomes

Primary

Measure	Time frame
Clinically significant prostate cancer diagnosis rate (ISUP Grade group 2 or higher) between single targeted biopsy and parallel biopsy in patients with early stage prostate cancer biopsy	—

Secondary

Measure	Time frame
All prostate cancer diagnoses;Clinically significant prostate cancer diagnosis rate by PI-RADS 3, 4, 5 lesion;Clinically all prostate cancer diagnosis rates by PI-RADS 3, 4, and 5 lesions;Diagnosis rate of clinically significant prostate cancer and all prostate cancers according to prostate biopsy method (transrectal vs. transperineal);Frequency of A/E within 2 weeks (± 1 week) after biopsy	—

Countries

Korea, Republic of

Contacts

Public ContactHyeong Dong Yuk

Seoul National University Hospital

armenia8@snu.ac.kr+82-2-2072-7497

Outcome results