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US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer

NCT04797078 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-10

No results posted yet for this study

Summary

We are conducting a randomised trial comparing outcomes of transperineal prostate biopsies under free-hand software assisted MRI/US fusion with transrectal biopsy guide software assisted MRI/US fusion. Primary outcome is the detection of clinically significant prostate cancer. Secondary outcomes is rate of complications including infection and sepsis, as well as feasibility and patient tolerability.

Conditions

Interventions

PROCEDURE

Transperineal biopsy

Transperineal free hand MRI-US fusion prostate biopsy

PROCEDURE

Transrectal biopsy

Transrectal MRI-US fusion prostate biopsy

Sponsors & Collaborators

  • Capio Sankt Görans Hospital

    collaborator OTHER

  • GHP Urologi Odenplan

    collaborator UNKNOWN

  • Urologifocus Stockholm

    collaborator UNKNOWN

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Tobias Nordström, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-11-01
Completion
2025-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797078 on ClinicalTrials.gov