← Back to Search

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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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

Ultrasound (US) Targeted Fusion Biopsy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03936127 — N/A
Prostate Cancer Research Study Groups: Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies, Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
Prostate Cancer Clinical Trial 2023: Ultrasound (US) Targeted Fusion Biopsy Highlights & Side Effects. Trial Name: NCT03936127 — N/A
Ultrasound (US) Targeted Fusion Biopsy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936127 — N/A
~29 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top