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Procedure
Targeted Fusion Biopsy Techniques for Prostate Cancer
N/A
Recruiting
Led By Nicola Schieda, MD
Research Sponsored by Dr. Nicola Schieda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Patient with a prior diagnosis of prostate cancer enrolled in active surveillance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Summary
This trialwill compare TP vs TR prostate cancer biopsies to see if one is better at diagnosing cancer, while looking at infection/pain/complication rates & procedure time. Expected sample size: 360 men.
Who is the study for?
This trial is for men who have an abnormal area detected on MRI, suggesting possible prostate cancer. They must have signed a consent form and been re-evaluated at The Ottawa Hospital's Prostate Cancer Assessment Centre. Men already diagnosed with prostate cancer under active surveillance or those with no abnormalities on MRI cannot participate.
What is being tested?
The study compares two biopsy methods to diagnose clinically significant prostate cancer: transperineal (TP) targeted fusion biopsy versus the conventional transrectal (TR) targeted fusion biopsy. It aims to see if TP is just as good as TR while also looking at infection rates, pain levels, other minor complications like bleeding or urinary issues, and how long the procedure takes.
What are the potential side effects?
Potential side effects from both biopsy techniques may include discomfort or pain during and after the procedure, risk of infection following the procedure, minor bleeding, difficulty urinating temporarily (urinary retention), among others.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am being actively monitored for prostate cancer without immediate treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Infection Rate
Secondary outcome measures
Malignant neoplasm of prostate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transperineal (TP) Ultrasound (US) Targeted Fusion BiopsyExperimental Treatment1 Intervention
Transperineal (TP) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
Group II: Transrectal (TR) Ultrasound (US) Targeted Fusion BiopsiesActive Control1 Intervention
Transrectal (TR) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
Find a Location
Who is running the clinical trial?
Dr. Nicola SchiedaLead Sponsor
The Ottawa Hospital Academic Medical AssociationOTHER
22 Previous Clinical Trials
2,536 Total Patients Enrolled
Nicola Schieda, MDPrincipal InvestigatorThe Ottawa Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being actively monitored for prostate cancer without immediate treatment.I have been reassessed at the TOH Prostate Cancer Assessment Centre for a targeted biopsy plan.
Research Study Groups:
This trial has the following groups:- Group 1: Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies
- Group 2: Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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