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Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy

NCT03936127 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-10-25

No results posted yet for this study

Summary

This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time.

The expected sample size at The Ottawa Hospital is 360 men.

Conditions

Interventions

PROCEDURE

Ultrasound (US) Targeted Fusion Biopsy

Ultrasound (US) Targeted Fusion Biopsy

Sponsors & Collaborators

  • The Ottawa Hospital Academic Medical Association

    collaborator OTHER

  • Dr. Nicola Schieda

    lead OTHER

Principal Investigators

  • Nicola Schieda, MD · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03936127 on ClinicalTrials.gov