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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

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

Study 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.Check my eligibility

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.See study design

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.

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.

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).

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being evaluated in this clinical examination?

"Affirmative. Clinicaltrials.gov information reveals that this research endeavour, which was opened up to applicants on October 11th 2022, is currently recruiting. Approximately 360 volunteers are required from one site of operation."

Answered by AI