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Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy

NCT02488096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-21

No results posted yet for this study

Summary

The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.

Conditions

Interventions

DEVICE

TRUS-Guided Biopsy

The standard care TRUS-guided biopsy is a schematic 12 core biopsy scheme with 2 cores taken from each of standard 6 zones. In some cases, the radiologist may take additional cores beyond 12 if suspicious areas are suspected from clinical findings or TRUS. TRUS-guided biopsies will be performed by a designated group of radiologists. An overall score out of 5 of likelihood of clinically significant prostate cancer will be recorded for each individual patient. The biopsy will be scheduled within 1 week of referral.

DEVICE

MRI + TRUS-Guided Biopsy

A designated radiologist will perform all MRI exams. The radiologist will identify locations of the prostate gland of the standard 12 cores to be taken and any additional lesions deemed to be suspicious for cancer. The procedure for the MRI-targeted biopsy will be exactly the same as the TRUS-guided biopsy except that an additional 2 cores per area may be taken beyond the standard 12 cores in areas that were previously identified by MRI on the map. The systematic 12-core biopsy will always be performed first. The radiologist performing the MRI-targeted biopsy will review the MRI targets prior to the biopsy as per standard of care, and he/she will also perform the TRUS-guided biopsies for this group. Patients will be scheduled for their biopsy \~ 1 week after the MRI.

Sponsors & Collaborators

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Jennifer St. Onge, PhD · Research, Regina Qu'Appelle Health Region

  • Ashok Verma, MB · Radiology, Regina Qu'Applle Health Region

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Canada

Study Locations

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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 NCT02488096 on ClinicalTrials.gov