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

October 21, 2022 updated by: Dr. Nicola Schieda

Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy for Diagnosis of Clinically Significant Prostate Cancers and to Eliminate Post-procedure Related Infections: A Randomized Control Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergo mp-MRI, at the discretion of the treating Urologist, when they are referred to the Cancer Assessment Clinic for their initial visit with a risk factor for prostate cancer (e.g. abnormal digital rectal exam [DRE] or elevated prostate serum antigen [PSA] level). Performing an mp-MRI in a man with risk factors for prostate cancer prior to an initial biopsy has become the standard of care for diagnosis of prostate cancer based on two large multi-center randomized control trials.

At the second visit, which is standard of care, the Urologist (or delegate [Resident, Fellow]) will discuss targeted biopsy and will introduce the trial design obtaining informed consent to participate. If consent is obtained, the patient will be randomly assigned to receive either the standard transrectal (TR) ultrasound guided targeted fusion biopsy or the novel transperineal (TP) targeted fusion biopsy system which has also been preliminarily validated as being accurate for detection of significant prostate cancers at targeted biopsy.

Patients will be notified regarding which method of targeted biopsy will be employed at time of scheduling.

Both the TR and TP biopsies will be conducted in existing biopsy rooms in The Ottawa Hospital (TOH) and will employ a brief 30-minute post-procedural observation period at which point the patient is required to urinate prior to discharge. Level of pain will be recorded by the ultrasound technologists during the 30 minutes observation period as well.

This study aims to compare ultrasound guided transrectal and transperineal targeted fusion biopsy for diagnosis of prostate cancer in abnormalities detected on MRI for the purpose of reducing or completely eliminating the risk of serious infection associated with the transrectal approach.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicola Schieda, MD
  • Phone Number: 613-759-0958
  • Email: nschieda@toh.ca

Study Contact Backup

  • Name: Betty Anne Schwarz, PhD
  • Phone Number: 17522 613-798-5555
  • Email: baschwarz@toh.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Contact:
          • Betty Anne Schwarz, PhD
          • Phone Number: 17522 613-798-5555
          • Email: baschwarz@toh.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • MRI positive - abnormal area detected
  • Patient re-evaluated in the TOH Prostate CAC (Cancer Assessment Centre) for planning of targeted biopsy
  • Signed Consent

Exclusion Criteria:

  • MRI negative - no abnormal area detected
  • Patient with a prior diagnosis of prostate cancer enrolled in active surveillance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
Transperineal (TP) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
Procedure: Ultrasound (US) Targeted Fusion Biopsy
Ultrasound (US) Targeted Fusion Biopsy
Active Comparator: Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies
Transrectal (TR) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
Procedure: Ultrasound (US) Targeted Fusion Biopsy
Ultrasound (US) Targeted Fusion Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.
Number of patients with or without post-procedural infection.
Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Significant Prostate Cancer
Time Frame: Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.
Gleason score of tumor in biopsy samples containing cancer.
Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Nicola Schieda

Collaborators

The Ottawa Hospital Academic Medical Association

Investigators

  • Principal Investigator: Nicola Schieda, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190262-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

The Principal Investigator will aim to have data available within 12 months of study completion.

IPD Sharing Access Criteria

  • Authors aim to have the study presented at conferences and published in a peer-reviewed journal.
  • Authors aim to have the study presented at conferences and published in a peer-reviewed journal.
  • A description of this clinical trial/study will be available on http://www.clinicaltrials.gov. Participants can search this website at anytime to obtain all study information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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