Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.

NCT04180592 | Unknown

• 1 other identifier: 6018147
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

MRI; Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

• Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]

  Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.

  Day 0

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  0 Day and at 30 day

• Tolerability of CT fusion biopsy

  Day 0

Study Arms (2)

CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy

EXPERIMENTAL

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.

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

Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy

OTHER

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.

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

Interventions

CT Fusion + Transrectal U/S Guided Prostate Biopsy PROCEDURE

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.

CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy; Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Jason P Izard, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized cross-over designed trial

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 27, 2019
• Study Start: November 6, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

CA (1)