Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936127
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
Dr. Nicola Schieda, The Ottawa Hospital

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 disease Intervention/treatment Phase
Prostate Cancer Procedure: Ultrasound (US) Targeted Fusion Biopsy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The expected sample size at The Ottawa Hospital is 360 men.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936127


Contacts
Layout table for location contacts
Contact: Nicola Schieda, MD 613-759-0958 nschieda@toh.ca
Contact: Betty Anne Schwarz, PhD 613-798-5555 ext 17522 baschwarz@toh.ca

Sponsors and Collaborators
Dr. Nicola Schieda
The Ottawa Hospital Academic Medical Association
Investigators
Layout table for investigator information
Principal Investigator: Nicola Schieda, MD The Ottawa Hospital
Additional Information:
Publications:

Layout table for additonal information
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    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Time Frame: The Principal Investigator will aim to have data available within 12 months of study completion.
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.
URL: http://www.clinicaltrials.gov.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Nicola Schieda, The Ottawa Hospital:
Transperineal
Transrectal
Fusion Biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases