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

Sponsor
Dr. Nicola Schieda (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03936127
Collaborator
The Ottawa Hospital Academic Medical Association (Other)
360
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Ultrasound (US) Targeted Fusion Biopsy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Infection Rate [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.

Secondary Outcome Measures

  1. Clinically Significant Prostate 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.]

    Gleason score of tumor in biopsy samples containing cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dr. Nicola Schieda
  • The Ottawa Hospital Academic Medical Association

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dr. Nicola Schieda, Director of Abdominal and Pelvic MRI, The Ottawa Hospital, The Ottawa Hospital
ClinicalTrials.gov Identifier:
NCT03936127
Other Study ID Numbers:
  • 20190262-01H
First Posted:
May 3, 2019
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Nicola Schieda, Director of Abdominal and Pelvic MRI, The Ottawa Hospital, The Ottawa Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021