Recruiting

MRI Guided Biopsies

Sponsor:

Queen's University

Code:

NCT04180592

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT Fusion + Transrectal U/S Guided Prostate Biopsy

Study Details

Brief summary:

The purpose of this study is to investigate a novel method of prostate biopsy using a computerized guidance system to accurately target lesions within the prostate. This method of prostate biopsy involves using a computerized technology that permits a lesion detected on MRI to be projected by a computer into 3 dimensions on a patient's CT scan. A CT guided biopsy can then be performed where a needle is advanced into the patient, where the computer has projected the image of the tumor that cannot normally be seen on CT. This is a randomized, cross over designed trial to compare this new method of prostate biopsy to the currently employed standard transrectal ultrasound guided prostate (TRUSP) biopsy technique.

Conditions

Prostate Cancer

Study ID

NCT04180592

Start date

Nov 6, 2019

Status verified date

Dec, 2019

Completion date

Aug, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants will be eligible for enrollment if they have both of:

1. Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5).
2. A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion.

Exclusion Criteria:

1. Uncorrected coagulopathy.
2. Active, untreated urinary tract infection.
3. Inability to access the rectum in order to perform TRUSP biopsy.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy

All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.

other: Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy

All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.

Interventions

CT Fusion + Transrectal U/S Guided Prostate Biopsy

All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.

Primary outcome measure

  • Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer] [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Jason P Izard, MD

613-548-2493jason.izard@kingstonhsc.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Jason Izard, MD

613-548-2493jason.izard@kingstonhsc.ca

More Information

Sponsor

Queen's University

Last update posted

Dec 4, 2019

Last verified

Dec, 2019

Keywords

  • MRI
  • Prostate Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2019-12-04.